Trial · NCT02820844
Efficacy and Safety of GSK1358820 in Subjects With Overactive Bladder
NCT02820844, Phase 3, Completed, GlaxoSmithKline; results first posted 2019-06-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of GSK1358820 in Subjects With Overactive Bladder. Trials, record NCT02820844. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02820844
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of GSK1358820 in Subjects With Overactive Bladder
- NCT number
- NCT02820844
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 250 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Urinary Bladder, Overactive
- Interventions
- GSK1358820, Placebo, Antibiotic therapy, Bladder diary, King's Health Questionnaire (KHQ), Overactive Bladder Symptom Score (OABSS), Treatment Benefit Scale (TBS)
- First posted
- 2016-07-01
- Last updated
- 2020-11-27
- Results first posted
- 2019-06-03
Source ClinicalTrials.gov
Registered outcomes119
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes at Week 12 After the First Treatment | Baseline (Pre-dose on Day 1) and Week 12 in Treatment Cycle 1 | Participants were instructed to enter data in a bladder diary over 3 consecutive days within a week prior to each scheduled visit (or within 28 days prior to Day 1), excluding the day of visit (this period was called the '3-day diary collection period'). The daily average of the number of incontinence episodes were calculated using formula; number of "Yes" response to the diary question of accidental urinary leakage divided by number of valid diary days in the visit. Baseline is the latest pre-dose 3- day diary assessment which has at least one valid diary day. Change from Baseline is any visit value minus Baseline value. Adjusted mean and standard error of adjusted mean has been reported. |
| Secondary | Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in the Average Volume Voided Per Micturition at Week 12 After the First Treatment | Baseline (Pre-dose on Day 1) and Week 12 in Treatment Cycle 1 | The total volume voided was measured and recorded by participants in the bladder diary, over a 24-hour period during the 3-day diary collection period. Volume voided per micturition was determined by dividing the total urine volume collected in 24-hour period by the participants with the number of the urinary volume records which are not missing. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value. Adjusted mean and standard error of adjusted mean has been reported. |
| Secondary | Treatment Phase 1 (Treatment Cycle 1): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes | Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1 | Participants were instructed to enter data in a bladder diary over 3 consecutive days within a week prior to each scheduled visit (or within 28 days prior to Day 1), excluding the day of visit (this period was called the '3-day diary collection period'). The daily average of the number of incontinence episodes were calculated from bladder diary data recorded by the participants during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of accidental urinary leakage with number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value. |
| Secondary | Treatment Phase 2 (Treatment Cycle 2): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes | Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, and Week 36 in Treatment Cycle 2 | Participants were instructed to enter data in a bladder diary over 3 consecutive days within a week prior to each scheduled visit (or within 28 days prior to Day 1), excluding the day of visit (this period was called the '3-day diary collection period'). The daily average of the number of incontinence episodes were calculated from bladder diary data recorded by the participants during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of accidental urinary leakage with number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value. FAS2 Population comprised all randomized participants who had at least 1 post-2nd treatment efficacy assessment after 2nd treatment. |
| Secondary | Treatment Phase 2 (Treatment Cycle 3): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes | Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3 | Participants were instructed to enter data in a bladder diary over 3 consecutive days within a week prior to each scheduled visit (or within 28 days prior to Day 1), excluding the day of visit (this period was called the '3-day diary collection period'). The daily average of the number of incontinence episodes were calculated from bladder diary data recorded by the participants during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of accidental urinary leakage with number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value. FAS3 Population comprised of all randomized participants who had at least 1 post-3rd treatment efficacy assessment after 3rd treatment. |
| Secondary | Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes | Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1 | Participants were instructed to enter data in a bladder diary over 3 consecutive days within a week prior to each scheduled visit (or within 28 days prior to Day 1), excluding the day of visit (this period was called the '3-day diary collection period'). The daily average of the number of incontinence episodes was calculated from bladder diary data recorded by the participants during the 3-day diary collection period by dividing the number of 'Yes' response to the diary question of accidental urinary leakage with number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100. |
| Secondary | Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes | Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 36 in Treatment Cycle 2 | Participants were instructed to enter data in a bladder diary over 3 consecutive days within a week prior to each scheduled visit (or within 28 days prior to Day 1), excluding the day of visit (this period was called the '3-day diary collection period'). The daily average of the number of incontinence episodes was calculated from bladder diary data recorded by the participants during the 3-day diary collection period by dividing the number of 'Yes' response to the diary question of accidental urinary leakage with number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100. |
| Secondary | Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes | Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3 | Participants were instructed to enter data in a bladder diary over 3 consecutive days within a week prior to each scheduled visit (or within 28 days prior to Day 1), excluding the day of visit (this period was called the '3-day diary collection period'). The daily average of the number of incontinence episodes was calculated from bladder diary data recorded by the participants during the 3-day diary collection period by dividing the number of 'Yes' response to the diary question of accidental urinary leakage with number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100. |
| Secondary | Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes | Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1 | The daily average number of urge incontinence episodes were calculated from bladder diary data recorded by the participants during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of accidental urinary leakage and sudden/ urgent need to urinate with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value. |
| Secondary | Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes | Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 36 in Treatment Cycle 2 | The daily average number of urge incontinence episodes were calculated from bladder diary data recorded by the participants during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of accidental urinary leakage and sudden/ urgent need to urinate with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value. |
1 to 10 of 119Source ClinicalTrials.gov
See all 119 registered outcomesOutcomes119
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes at Week 12 After the First Treatment | Baseline (Pre-dose on Day 1) and Week 12 in Treatment Cycle 1 | Full Analysis Set 1(FAS1) Population comprised of all randomized participants who had at least 1 post-Baseline efficacy assessment. Only those participants with data available at specified time point were analyzed. | Episodes | MEAN |
| SECONDARY | Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in the Average Volume Voided Per Micturition at Week 12 After the First Treatment | Baseline (Pre-dose on Day 1) and Week 12 in Treatment Cycle 1 | FAS1 Population. Only those participants with data available at specified time point were analyzed. | Milliliter | MEAN |
| SECONDARY | Treatment Phase 1 (Treatment Cycle 1): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes | Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1 | FAS1 Population. All the participants in this population were analyzed (124, 124 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles). | Episodes | MEAN |
| SECONDARY | Treatment Phase 2 (Treatment Cycle 2): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes | Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, and Week 36 in Treatment Cycle 2 | FAS2 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles). | Episodes | MEAN |
| SECONDARY | Treatment Phase 2 (Treatment Cycle 3): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes | Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3 | FAS3 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles). | Episodes | MEAN |
| SECONDARY | Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes | Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1 | FAS1 Population. All the participants in this population were analyzed (124, 124 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles). | Percent change | MEAN |
| SECONDARY | Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes | Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 36 in Treatment Cycle 2 | FAS2 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles). | Percent change | MEAN |
| SECONDARY | Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes | Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3 | FAS3 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles). | Percent change | MEAN |
| SECONDARY | Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes | Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1 | FAS1 Population. All the participants in this population were analyzed (124, 124 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles). | Episodes | MEAN |
| SECONDARY | Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes | Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 36 in Treatment Cycle 2 | FAS2 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles). | Episodes | MEAN |
1 to 10 of 119Source ClinicalTrials.gov
See all 119 outcomesResults by group3,016
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes at Week 12 After the First Treatment | Treatment Cycle 1: Placebo | -1.25 | Standard Error 0.375 | Episodes | |
| Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes at Week 12 After the First Treatment | Treatment Cycle 1: GSK1358820 100 U | -3.42 | Standard Error 0.381 | Episodes | |
| Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in the Average Volume Voided Per Micturition at Week 12 After the First Treatment | Treatment Cycle 1: Placebo | -0.22 | Standard Error 4.329 | Milliliter | |
| Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in the Average Volume Voided Per Micturition at Week 12 After the First Treatment | Treatment Cycle 1: GSK1358820 100 U | 29.47 | Standard Error 4.390 | Milliliter | |
| Treatment Phase 1 (Treatment Cycle 1): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes | Treatment Cycle 1: Placebo | Week 2; n=124, 123 | -0.84 | Standard Deviation 2.883 | Episodes |
| Treatment Phase 1 (Treatment Cycle 1): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes | Treatment Cycle 1: GSK1358820 100 U | Week 2; n=124, 123 | -3.24 | Standard Deviation 4.355 | Episodes |
| Treatment Phase 1 (Treatment Cycle 1): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes | Treatment Cycle 1: Placebo | Week 6; n=124, 120 | -0.83 | Standard Deviation 3.022 | Episodes |
| Treatment Phase 1 (Treatment Cycle 1): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes | Treatment Cycle 1: GSK1358820 100 U | Week 6; n=124, 120 | -3.62 | Standard Deviation 4.447 | Episodes |
| Treatment Phase 1 (Treatment Cycle 1): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes | Treatment Cycle 1: Placebo | Week 12; n=122, 122 | -0.92 | Standard Deviation 3.402 | Episodes |
| Treatment Phase 1 (Treatment Cycle 1): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes | Treatment Cycle 1: GSK1358820 100 U | Week 12; n=122, 122 | -3.41 | Standard Deviation 4.394 | Episodes |
1 to 10 of 3,016Source ClinicalTrials.gov
See all 3,016 results by groupParticipant flow54
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-blinded (Up to 48 Weeks) | STARTED | Treatment Cycle 1: Placebo | 124 | |
| Double-blinded (Up to 48 Weeks) | STARTED | Treatment Cycle 1: GSK1358820 100 U | 124 | |
| Double-blinded (Up to 48 Weeks) | STARTED | Treatment Cycle 2: Placebo / GSK1358820 100 U | 0 | |
| Double-blinded (Up to 48 Weeks) | STARTED | Treatment Cycle 2: GSK1358820 100 U / GSK1358820 100 U | 0 | |
| Double-blinded (Up to 48 Weeks) | STARTED | Treatment Cycle 3: Placebo / GSK1358820 100 U | 0 | |
| Double-blinded (Up to 48 Weeks) | STARTED | Treatment Cycle 3: GSK1358820 100 U / GSK1358820 100 U | 0 | |
| Double-blinded (Up to 48 Weeks) | COMPLETED | Treatment Cycle 1: Placebo | 119 | |
| Double-blinded (Up to 48 Weeks) | COMPLETED | Treatment Cycle 1: GSK1358820 100 U | 115 | |
| Double-blinded (Up to 48 Weeks) | COMPLETED | Treatment Cycle 2: Placebo / GSK1358820 100 U | 0 | |
| Double-blinded (Up to 48 Weeks) | COMPLETED | Treatment Cycle 2: GSK1358820 100 U / GSK1358820 100 U | 0 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 participant flowAdverse events210
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nasopharyngitis | Infections and infestations | Treatment Cycle 1: Placebo | 13 | 124 | 14 |
| other | Nasopharyngitis | Infections and infestations | Treatment Cycle 1: GSK1358820 100 U | 22 | 124 | 26 |
| other | Nasopharyngitis | Infections and infestations | Treatment Cycle 2: Placebo / GSK1358820 100 U | 14 | 108 | 18 |
| other | Nasopharyngitis | Infections and infestations | Treatment Cycle 2: GSK1358820 100 U / GSK1358820 100 U | 14 | 88 | 14 |
| other | Nasopharyngitis | Infections and infestations | Treatment Cycle 3: Placebo / GSK1358820 100 U | 5 | 56 | 8 |
| other | Nasopharyngitis | Infections and infestations | Treatment Cycle 3: GSK1358820 100 U / GSK1358820 100 U | 5 | 43 | 6 |
| other | Urinary tract infection | Infections and infestations | Treatment Cycle 1: Placebo | 10 | 124 | 11 |
| other | Urinary tract infection | Infections and infestations | Treatment Cycle 1: GSK1358820 100 U | 22 | 124 | 31 |
| other | Urinary tract infection | Infections and infestations | Treatment Cycle 2: Placebo / GSK1358820 100 U | 30 | 108 | 40 |
| other | Urinary tract infection | Infections and infestations | Treatment Cycle 2: GSK1358820 100 U / GSK1358820 100 U | 19 | 88 | 22 |
1 to 10 of 210Source ClinicalTrials.gov
See all 210 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment Cycle 1: Placebo | 0 | 124 |
| Total, all-cause mortality | Treatment Cycle 1: GSK1358820 100 U | 0 | 124 |
| Total, all-cause mortality | Treatment Cycle 2: Placebo / GSK1358820 100 U | 0 | 108 |
| Total, all-cause mortality | Treatment Cycle 2: GSK1358820 100 U / GSK1358820 100 U | 0 | 88 |
| Total, all-cause mortality | Treatment Cycle 3: Placebo / GSK1358820 100 U | 0 | 56 |
| Total, all-cause mortality | Treatment Cycle 3: GSK1358820 100 U / GSK1358820 100 U | 0 | 43 |
| Total, other adverse events | Treatment Cycle 1: Placebo | 29 | 124 |
| Total, other adverse events | Treatment Cycle 1: GSK1358820 100 U | 53 | 124 |
| Total, other adverse events | Treatment Cycle 2: Placebo / GSK1358820 100 U | 49 | 108 |
| Total, other adverse events | Treatment Cycle 2: GSK1358820 100 U / GSK1358820 100 U | 40 | 88 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Treatment Cycle 1: GSK1358820 100 U vs Treatment Cycle 1: Placebo: Treatment Phase 1 (Treatment Cycle 1): Number of Participants Using Clean Intermittent Catheterization (CIC) for Urinary Retention or Elevated PVR | Trial comparisons |
| Treatment Cycle 1: GSK1358820 100 U vs Treatment Cycle 1: Placebo: Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Urinary Tract Infection (UTI) | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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GET https://conductscience.org/api/trials/v1/NCT02820844/registered?page=2