Trial · NCT00601484
An Effectiveness and Safety Study of PF-04383119 for the Treatment of Pain in Interstitial Cystitis
NCT00601484, Phase 2, Completed, Pfizer; results first posted 2021-05-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Effectiveness and Safety Study of PF-04383119 for the Treatment of Pain in Interstitial Cystitis. Trials, record NCT00601484. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00601484
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Effectiveness and Safety Study of PF-04383119 for the Treatment of Pain in Interstitial Cystitis
- NCT number
- NCT00601484
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 65 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Cystitis, Interstitial
- Interventions
- PF-04383119, Placebo
- First posted
- 2008-01-28
- Last updated
- 2021-05-13
- Results first posted
- 2021-05-13
Source ClinicalTrials.gov
Registered outcomes46
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Average Daily Pain Score at Week 6 | Baseline, Week 6 | Participants assessed their average interstitial cystitis pain intensity during the last 24 hours on an 11-point numeric rating scale (NRS) ranging from 0 (no interstitial cystitis pain) to 10 (worst possible interstitial cystitis pain); where higher scores indicated higher pain. The average daily pain score was calculated as the mean of the scores over the last 7 days prior to each assessment time point. Here, 'Number analyzed' = participants with available data for each specified category. |
| Secondary | Change From Baseline in Average Daily Pain Score at Week 2, 4, 10 and 16 | Baseline, Week 2, 4, 10, 16 | Participants assessed their average interstitial cystitis pain intensity during the last 24 hours on an 11-point NRS ranging from 0 (no interstitial cystitis pain) to 10 (worst possible interstitial cystitis pain); where higher scores indicated higher pain. The average daily pain score was calculated as the mean of the scores over the last 7 days prior to each assessment time point. |
| Secondary | Percent Change From Baseline in Average Daily Pain Score at Week 2, 4, 6, 10 and 16 | Baseline, Week 2, 4, 6, 10, 16 | Participants assessed their average interstitial cystitis pain intensity during the last 24 hours on an 11-point NRS ranging from 0 (no interstitial cystitis pain) to 10 (worst possible interstitial cystitis pain); where higher scores indicated higher pain. The average daily pain score was calculated as the mean of the scores over the last 7 days prior to each assessment time point. |
| Secondary | Change From Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score at Week 2, 4, 6, 10 and 16 | Baseline, Week 2, 4, 6, 10, 16 | The ICSI contained 4 questions that measured symptom severity including urinary urgency, urinary frequency, nocturia and pain/burning/discomfort/pressure in the bladder. Each question in the ICSI was rated on a 0 (no symptoms) to 5 (severe symptoms) scale, with higher scores indicating greater symptom severity. The sum of the individual question ratings was the total score for the ICSI. Total score ranged from 0 (no symptoms) to 20 (severe symptoms), with higher score indicating greater symptom severity. |
| Secondary | Percent Change From Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score at Week 2, 4, 6, 10 and 16 | Baseline, Week 2, 4, 6, 10, 16 | The ICSI contained 4 questions that measured symptom severity including urinary urgency, urinary frequency, nocturia and pain/burning/discomfort/pressure in the bladder. Each question in the ICSI was rated on a 0 (no symptoms) to 5 (severe symptoms) scale, with higher scores indicating greater symptom severity. The sum of the individual question ratings was the total score for the ICSI. Total score ranged from 0 (no symptoms) to 20 (severe symptoms), with higher score indicating greater symptom severity. |
| Secondary | Change From Baseline in Number of Micturitions Per 24 Hours at Week 2, 4, 6, 10 and 16 | Baseline, Week 2, 4, 6, 10, 16 | The micturition frequency per 24 hours was calculated from the sum of voluntary voids divided by the number of diary days over which they were collected. |
| Secondary | Percent Change From Baseline in Number of Micturitions Per 24 Hours at Week 2, 4, 6, 10 and 16 | Baseline, Week 2, 4, 6, 10, 16 | The micturition frequency per 24 hours was calculated from the sum of voluntary voids divided by the number of diary days over which they were collected. |
| Secondary | Change From Baseline in Number of Nocturnal Micturitions Per Night at Week 2, 4, 6, 10 and 16 | Baseline, Week 2, 4, 6, 10, 16 | The nocturnal frequency per night was calculated as the sum of voluntary voids that occurred during a night's sleep, divided by the number of nights over which this was collected. |
| Secondary | Percent Change From Baseline in Number of Nocturnal Micturitions Per Night at Week 2, 4, 6, 10 and 16 | Baseline, Week 2, 4, 6, 10, 16 | The nocturnal frequency per night was calculated as the sum of voluntary voids that occurred during a night's sleep, divided by the number of nights over which this was collected. Percent change from baseline was calculated for participants who reported greater than 0 episodes at baseline. |
| Secondary | Change From Baseline in Number of Incontinence Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16 | Baseline, Week 2, 4, 6, 10, 16 | The incontinence episode frequency per 24 hours was calculated as the sum of any incontinence episodes occurring during the diary period when this was measured, divided by the number of days over which they were recorded. |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 registered outcomesOutcomes46
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Average Daily Pain Score at Week 6 | Baseline, Week 6 | Restricted Full Analysis Set(rFAS): All randomized participants who received at least 1 dose of treatment, completed at least 5 diary days during 7 days prior to randomization, had at least 1 diary day post-randomization, and who provided baseline and post-randomization primary efficacy data for 4 or more days within the predefined diary windows. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Average Daily Pain Score at Week 2, 4, 10 and 16 | Baseline, Week 2, 4, 10, 16 | rFAS population. Here, 'Number analyzed' = participants with available data for each specified category. | units on a scale | MEAN |
| SECONDARY | Percent Change From Baseline in Average Daily Pain Score at Week 2, 4, 6, 10 and 16 | Baseline, Week 2, 4, 6, 10, 16 | rFAS population. Here, 'Number analyzed' = participants with available data for each specified category. | percent change | MEAN |
| SECONDARY | Change From Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score at Week 2, 4, 6, 10 and 16 | Baseline, Week 2, 4, 6, 10, 16 | rFAS population. Here, 'Number analyzed' = participants with available data for each specified category. | units on a scale | MEAN |
| SECONDARY | Percent Change From Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score at Week 2, 4, 6, 10 and 16 | Baseline, Week 2, 4, 6, 10, 16 | RFAS population. Here, 'Number analyzed' = participants with available data for each specified category. | percent change | MEAN |
| SECONDARY | Change From Baseline in Number of Micturitions Per 24 Hours at Week 2, 4, 6, 10 and 16 | Baseline, Week 2, 4, 6, 10, 16 | rFAS population. Here, 'Number analyzed' = participants with available data for each specified category. | micturitions per 24 hours | MEAN |
| SECONDARY | Percent Change From Baseline in Number of Micturitions Per 24 Hours at Week 2, 4, 6, 10 and 16 | Baseline, Week 2, 4, 6, 10, 16 | rFAS population. Here, 'Number analyzed' = participants with available data for each specified category. | percent change | MEDIAN |
| SECONDARY | Change From Baseline in Number of Nocturnal Micturitions Per Night at Week 2, 4, 6, 10 and 16 | Baseline, Week 2, 4, 6, 10, 16 | rFAS population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category. | micturitions per night | MEAN |
| SECONDARY | Percent Change From Baseline in Number of Nocturnal Micturitions Per Night at Week 2, 4, 6, 10 and 16 | Baseline, Week 2, 4, 6, 10, 16 | rFAS population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category. | percent change | MEDIAN |
| SECONDARY | Change From Baseline in Number of Incontinence Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16 | Baseline, Week 2, 4, 6, 10, 16 | rFAS population. Here, 'Number analyzed' = participants with available data for each specified category. | episodes per 24 hours | MEAN |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 outcomesResults by group464
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Average Daily Pain Score at Week 6 | Tanezumab | Baseline | 6.4 | Standard Deviation 1.39 | units on a scale |
| Change From Baseline in Average Daily Pain Score at Week 6 | Placebo | Baseline | 5.9 | Standard Deviation 1.15 | units on a scale |
| Change From Baseline in Average Daily Pain Score at Week 6 | Tanezumab | Change at Week 6 | -2.3 | Standard Deviation 1.88 | units on a scale |
| Change From Baseline in Average Daily Pain Score at Week 6 | Placebo | Change at Week 6 | -1.1 | Standard Deviation 1.49 | units on a scale |
| Change From Baseline in Average Daily Pain Score at Week 2, 4, 10 and 16 | Tanezumab | Change at Week 2 | -1.5 | Standard Deviation 1.64 | units on a scale |
| Change From Baseline in Average Daily Pain Score at Week 2, 4, 10 and 16 | Placebo | Change at Week 2 | -0.9 | Standard Deviation 1.15 | units on a scale |
| Change From Baseline in Average Daily Pain Score at Week 2, 4, 10 and 16 | Tanezumab | Change at Week 4 | -2.1 | Standard Deviation 2.04 | units on a scale |
| Change From Baseline in Average Daily Pain Score at Week 2, 4, 10 and 16 | Placebo | Change at Week 4 | -1.0 | Standard Deviation 1.44 | units on a scale |
| Change From Baseline in Average Daily Pain Score at Week 2, 4, 10 and 16 | Tanezumab | Change at Week 10 | -2.2 | Standard Deviation 1.93 | units on a scale |
| Change From Baseline in Average Daily Pain Score at Week 2, 4, 10 and 16 | Placebo | Change at Week 10 | -1.4 | Standard Deviation 1.87 | units on a scale |
1 to 10 of 464Source ClinicalTrials.gov
See all 464 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tanezumab | 34 | |
| Overall Study | STARTED | Placebo | 31 | |
| Overall Study | Treated | Tanezumab | 34 | |
| Overall Study | Treated | Placebo | 30 | |
| Overall Study | COMPLETED | Tanezumab | 29 | |
| Overall Study | COMPLETED | Placebo | 23 | |
| Overall Study | NOT COMPLETED | Tanezumab | 5 | |
| Overall Study | NOT COMPLETED | Placebo | 8 |
Source ClinicalTrials.gov
Adverse events216
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 | Anaemia | Blood and lymphatic system disorders | Tanezumab | 0 | 34 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 1 | 30 | |
| other | Palpitations | Cardiac disorders | Tanezumab | 1 | 34 | |
| other | Palpitations | Cardiac disorders | Placebo | 0 | 30 | |
| other | Ear pruritus | Ear and labyrinth disorders | Tanezumab | 1 | 34 | |
| other | Ear pruritus | Ear and labyrinth disorders | Placebo | 0 | 30 | |
| other | Tympanic membrane perforation | Ear and labyrinth disorders | Tanezumab | 1 | 34 | |
| other | Tympanic membrane perforation | Ear and labyrinth disorders | Placebo | 0 | 30 | |
| other | Altered visual depth perception | Eye disorders | Tanezumab | 1 | 34 | |
| other | Altered visual depth perception | Eye disorders | Placebo | 0 | 30 |
1 to 10 of 216Source ClinicalTrials.gov
See all 216 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tanezumab | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Tanezumab | 23 | 34 |
| Total, other adverse events | Placebo | 17 | 30 |
| Total, serious adverse events | Tanezumab | 2 | 34 |
| Total, serious adverse events | Placebo | 4 | 30 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32734597 | DERIVED |
Source PubMed
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 comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Tanezumab vs Placebo: Number of Participants With Clinically Significant Change From Baseline in Vital Signs | Trial comparisons |
| Tanezumab vs Placebo: Number of Participants With Clinically Significant Change From Baseline in Body Weight | Trial comparisons |
| Tanezumab vs Placebo: Number of Participants With Clinically Significant Change From Baseline in Physical Examination | Trial comparisons |
| Tanezumab vs Placebo: Number of Participants With Laboratory Abnormalities | Trial comparisons |
| Tanezumab vs Placebo: Number of Participants With Clinically Significant Change From Baseline in Neurologic Examination | Trial comparisons |
| Tanezumab vs Placebo: serious adverse events | 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.
For software
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