Trial · NCT04026113
Linaclotide Safety and Efficacy in Pediatric Participants, 6 to 17 Years of Age, With Irritable Bowel Syndrome With Constipation (IBS-C) or Functional Constipation (FC)
NCT04026113, Phase 3, Completed, AbbVie; results first posted 2024-11-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Linaclotide Safety and Efficacy in Pediatric Participants, 6 to 17 Years of Age, With Irritable Bowel Syndrome With Constipation (IBS-C) or Functional Constipation (FC). Trials, record NCT04026113. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04026113
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Linaclotide Safety and Efficacy in Pediatric Participants, 6 to 17 Years of Age, With Irritable Bowel Syndrome With Constipation (IBS-C) or Functional Constipation (FC)
- NCT number
- NCT04026113
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 438 participants, actual
- Lead sponsor
- AbbVie
- Conditions
- Functional Constipation, Irritable Bowel Syndrome With Constipation
- Interventions
- Linaclotide, Placebo
- First posted
- 2019-07-19
- Last updated
- 2024-11-26
- Other registries' IDs
- eudract:2019-001500-38
- Results first posted
- 2024-11-26
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Functional Constipation (FC) Participants: Change From Baseline in 12-week SBM (Spontaneous Bowel Movement) Frequency Rate (SBMs/Week) During the Study Intervention Period | Baseline, up to 12 weeks | An SBM is defined as a BM that occurs in the absence of laxative, enema, or suppository use on the calendar day of the bowel movement (BM) or the calendar day before the BM. Assessments of BM characteristics that determine occurrences of SBM (ie, BM frequency and rescue medication use) were measured by using the eDiary completed twice daily (morning and evening) on the eDiary (Electronic Diary) device. |
| Primary | Irritable Bowel Syndrome With Constipation (IBS-C) Participants: 6/12 Weeks APS (Abdominal Pain and SBM) + 2 Responder Rate | 12 Weeks | 6/12 weeks APS + 2 responder=participant who meets the weekly APS + 2 responder criteria ≥6 of the 12 weeks of the intervention period. Weekly APS +2 responder=participant who has an increase of ≥2 in the SBM weekly rate from baseline, AND a decrease of ≥30% in mean abdominal pain score from baseline, during that study intervention week. Assessments of abdominal pain and BM characteristics that determine occurrences of SBMs were measured by using an eDiary completed twice daily (AM and PM). Assessments of abdominal pain were measured using a 5-point scale where 0=none and 4=a lot. A participant's abdominal pain score=mean of the non-missing abdominal pain scores during the specified period. Responder rate=percentage of participants who were 6/12 weeks APS + 2 responders. A participant had to have ≥4 completed diary days in the analysis week to be considered a responder for that week and was otherwise considered a non-responder for that week. |
| Secondary | Functional Constipation (FC) Participants: Change From Baseline in 12-week Stool Consistency During the Study Intervention Period | Baseline, up to 12 weeks | Stool consistency was measured twice daily, once in the morning and once in the evening eDiary, using the 7-point ordinal pediatric Bristol Stool Form Scale (p-BSFS): Type 1: Looks like small hard lumps or balls, like pebbles; Type 2: Looks like fat sausage shape but lumpy and hard; Type 3: Looks like a sausage but with cracks on it; Type 4: Looks like a sausage or snake, smooth and soft; Type 5: Looks like chicken nuggets, soft smooth blobs; Type 6: Looks like oatmeal, fluffy mushy pieces; Type 7: Looks like a milkshake, watery. A participant's p-BSFS score for the study intervention period was the average of the non-missing p-BSFS scores from the SBMs reported by the participant during the 12-week study intervention period. |
| Secondary | Irritable Bowel Syndrome With Constipation (IBS-C) Participants: Change From Baseline in 12-week SBM Frequency Rate (SBMs/Week) During the Study Intervention Period | Baseline, up to 12 Weeks | An SBM is defined as a BM that occurs in the absence of laxative, enema, or suppository use on the calendar day of the BM or the calendar day before the BM. Assessments of BM characteristics that determine occurrences of SBM (ie, BM frequency and rescue medication use) were measured by using the eDiary completed twice daily (morning and evening) on the eDiary (Electronic Diary) device. A participant's SBMs/week for the study intervention period was the average of the non-missing SBMs/week reported by the participant during the 12-week study intervention period. |
| Secondary | Irritable Bowel Syndrome With Constipation (IBS-C) Participants: Change From Baseline in 12-week Abdominal Pain During the Study Intervention Period | Baseline, up to 12 weeks | Assessments of abdominal pain were measured twice daily, once in the morning and once in the evening eDiary, using a 5-point scale where a score of 0 indicates no abdominal pain scores and a score of 4 indicates a lot of abdominal pain. Assessments of abdominal pain were measured using a 5-point scale where '0' indicates no abdominal pain and '4' indicates a lot of abdominal pain. The participant's abdominal pain score was derived as the mean of the non-missing morning and evening abdominal pain scores during the specified period. |
| Secondary | Irritable Bowel Syndrome With Constipation (IBS-C) Participants: Change From Baseline in 12-week Stool Consistency During the Study Intervention Period | Baseline, up to 12 weeks | Stool consistency was measured twice daily, once in the morning and once in the evening eDiary, using the 7-point ordinal p-BSFS (pediatric Bristol Stool Form Scale: Type 1: Looks like small hard lumps or balls, like pebbles Type 2: Looks like fat sausage shape but lumpy and hard Type 3: Looks like a sausage but with cracks on it Type 4: Looks like a sausage or snake, smooth and soft Type 5: Looks like chicken nuggets, soft smooth blobs Type 6: Looks like oatmeal, fluffy mushy pieces Type 7: Looks like a milkshake, watery. A participant's p-BSFS score for the study intervention period was the average of the non-missing p-BSFS scores from the SBMs reported by the participant during the 12-week study intervention period. |
| Secondary | Irritable Bowel Syndrome With Constipation (IBS-C) Participants: 6/12 Weeks SBM + 2 Responder Rate | 12 weeks | A 6/12 weeks SBM + 2 responder is a participant that meets the weekly SBM + 2 responder criteria for at least 6 out of the 12 weeks of the intervention period. A weekly SBM +2 responder is a participant who has an increase of at least 2 in the SBM weekly rate from baseline, Assessments of BM characteristics that determine occurrences of SBMs (ie, BM frequency and rescue medication use) were measured by using an eDiary completed twice daily (morning and evening). Responder rate is presented as the percentage of participants who were 6/12 weeks SBM + 2 responders. |
| Secondary | Irritable Bowel Syndrome With Constipation (IBS-C) Participants: 6/12 Weeks Abdominal Pain Responder | 12 Weeks | A 6/12 weeks abdominal pain responder is a participant that meets the weekly abdominal pain responder criteria for at least 6 out of the 12 weeks of the intervention period. A weekly abdominal pain responder is a participant who has a decrease of at least 30% in the mean abdominal pain score from baseline, during that study intervention week. Assessments of abdominal pain were measured by using an eDiary completed twice daily (morning and evening) and were measured using a 5-point scale where '0' indicates no abdominal pain and '4' indicates a lot of abdominal pain. The participant's abdominal pain score was derived as the mean of the non-missing abdominal pain scores during the specified period. Responder rate is presented as the percentage of participants who were 6/12 weeks abdominal pain responders. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Functional Constipation (FC) Participants: Change From Baseline in 12-week SBM (Spontaneous Bowel Movement) Frequency Rate (SBMs/Week) During the Study Intervention Period | Baseline, up to 12 weeks | Modified Intent-to-Treat Population: all randomized participants who received at least 1 dose of double-blind study intervention. Participants with analysis values at both baseline and postbaseline during the specified time period. | SBMs | LEAST_SQUARES_MEAN |
| PRIMARY | Irritable Bowel Syndrome With Constipation (IBS-C) Participants: 6/12 Weeks APS (Abdominal Pain and SBM) + 2 Responder Rate | 12 Weeks | Modified Intent-to-Treat Population: all randomized participants who received at least 1 dose of double-blind study intervention. Participants with analysis values at both baseline and postbaseline during the specified time period. | percentage of participants | NUMBER |
| SECONDARY | Functional Constipation (FC) Participants: Change From Baseline in 12-week Stool Consistency During the Study Intervention Period | Baseline, up to 12 weeks | Modified Intent-to-Treat Population: all randomized participants who received at least 1 dose of double-blind study intervention. Participants with analysis values at both baseline and postbaseline during the specified time period. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Irritable Bowel Syndrome With Constipation (IBS-C) Participants: Change From Baseline in 12-week SBM Frequency Rate (SBMs/Week) During the Study Intervention Period | Baseline, up to 12 Weeks | Modified Intent-to-Treat Population: all randomized participants who received at least 1 dose of double-blind study intervention. Participants with analysis values at both baseline and postbaseline during the specified time period. | SBMs/week | MEAN |
| SECONDARY | Irritable Bowel Syndrome With Constipation (IBS-C) Participants: Change From Baseline in 12-week Abdominal Pain During the Study Intervention Period | Baseline, up to 12 weeks | Modified Intent-to-Treat Population: all randomized participants who received at least 1 dose of double-blind study intervention. Participants with analysis values at both baseline and postbaseline during the specified time period. | units on a scale | MEAN |
| SECONDARY | Irritable Bowel Syndrome With Constipation (IBS-C) Participants: Change From Baseline in 12-week Stool Consistency During the Study Intervention Period | Baseline, up to 12 weeks | Modified Intent-to-Treat Population: all randomized participants who received at least 1 dose of double-blind study intervention. Participants with analysis values at both baseline and postbaseline during the specified time period. | units on a scale | MEAN |
| SECONDARY | Irritable Bowel Syndrome With Constipation (IBS-C) Participants: 6/12 Weeks SBM + 2 Responder Rate | 12 weeks | Modified Intent-to-Treat Population: all randomized participants who received at least 1 dose of double-blind study intervention. Participants with analysis values at both baseline and postbaseline during the specified time period. | percentage of participants | NUMBER |
| SECONDARY | Irritable Bowel Syndrome With Constipation (IBS-C) Participants: 6/12 Weeks Abdominal Pain Responder | 12 Weeks | Modified Intent-to-Treat Population: all randomized participants who received at least 1 dose of double-blind study intervention. Participants with analysis values at both baseline and postbaseline during the specified time period. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Functional Constipation (FC) Participants: Change From Baseline in 12-week SBM (Spontaneous Bowel Movement) Frequency Rate (SBMs/Week) During the Study Intervention Period | FC Participants: Placebo | 1.050 | Standard Error 0.187 | SBMs | |
| Functional Constipation (FC) Participants: Change From Baseline in 12-week SBM (Spontaneous Bowel Movement) Frequency Rate (SBMs/Week) During the Study Intervention Period | FC Participants: Linaclotide 72 μg | 2.220 | Standard Error 0.187 | SBMs | |
| Irritable Bowel Syndrome With Constipation (IBS-C) Participants: 6/12 Weeks APS (Abdominal Pain and SBM) + 2 Responder Rate | IBS-C Participants: Linaclotide 145 μg | 22.6 | percentage of participants | ||
| Irritable Bowel Syndrome With Constipation (IBS-C) Participants: 6/12 Weeks APS (Abdominal Pain and SBM) + 2 Responder Rate | IBS-C Participants: Linaclotide 290 μg | 23.4 | percentage of participants | ||
| Functional Constipation (FC) Participants: Change From Baseline in 12-week Stool Consistency During the Study Intervention Period | FC Participants: Placebo | 0.685 | Standard Error 0.078 | units on a scale | |
| Functional Constipation (FC) Participants: Change From Baseline in 12-week Stool Consistency During the Study Intervention Period | FC Participants: Linaclotide 72 μg | 1.108 | Standard Error 0.077 | units on a scale | |
| Irritable Bowel Syndrome With Constipation (IBS-C) Participants: Change From Baseline in 12-week SBM Frequency Rate (SBMs/Week) During the Study Intervention Period | IBS-C Participants: Linaclotide 145 μg | 2.347 | Standard Deviation 3.3335 | SBMs/week | |
| Irritable Bowel Syndrome With Constipation (IBS-C) Participants: Change From Baseline in 12-week SBM Frequency Rate (SBMs/Week) During the Study Intervention Period | IBS-C Participants: Linaclotide 290 μg | 2.747 | Standard Deviation 2.8861 | SBMs/week | |
| Irritable Bowel Syndrome With Constipation (IBS-C) Participants: Change From Baseline in 12-week Abdominal Pain During the Study Intervention Period | IBS-C Participants: Linaclotide 145 μg | -0.837 | Standard Deviation 0.9313 | units on a scale | |
| Irritable Bowel Syndrome With Constipation (IBS-C) Participants: Change From Baseline in 12-week Abdominal Pain During the Study Intervention Period | IBS-C Participants: Linaclotide 290 μg | -0.837 | Standard Deviation 0.8809 | units on a scale |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow28
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-Blind Treatment Period (12 Weeks) | STARTED | FC Participants: Placebo | 164 | |
| Double-Blind Treatment Period (12 Weeks) | STARTED | FC Participants: Linaclotide 72 μg | 166 | |
| Double-Blind Treatment Period (12 Weeks) | STARTED | IBS-C Participants: Linaclotide 145 μg | 55 | |
| Double-Blind Treatment Period (12 Weeks) | STARTED | IBS-C Participants: Linaclotide 290 μg | 53 | |
| Double-Blind Treatment Period (12 Weeks) | Randomized and Treated | FC Participants: Placebo | 164 | |
| Double-Blind Treatment Period (12 Weeks) | Randomized and Treated | FC Participants: Linaclotide 72 μg | 164 | |
| Double-Blind Treatment Period (12 Weeks) | Randomized and Treated | IBS-C Participants: Linaclotide 145 μg | 55 | |
| Double-Blind Treatment Period (12 Weeks) | Randomized and Treated | IBS-C Participants: Linaclotide 290 μg | 53 | |
| Double-Blind Treatment Period (12 Weeks) | COMPLETED | FC Participants: Placebo | 145 | |
| Double-Blind Treatment Period (12 Weeks) | COMPLETED | FC Participants: Linaclotide 72 μg | 148 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 participant flowAdverse events32
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 | ABDOMINAL PAIN | Gastrointestinal disorders | FC Participants: Linaclotide 72 μg | 1 | 166 | 1 |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | FC Participants: Placebo | 2 | 164 | 2 |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | IBS-C Participants: Linaclotide 145 μg | 2 | 55 | 2 |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | IBS-C Participants: Linaclotide 290 μg | 0 | 53 | 0 |
| other | CONSTIPATION | Gastrointestinal disorders | FC Participants: Linaclotide 72 μg | 1 | 166 | 1 |
| other | CONSTIPATION | Gastrointestinal disorders | FC Participants: Placebo | 0 | 164 | 0 |
| other | CONSTIPATION | Gastrointestinal disorders | IBS-C Participants: Linaclotide 145 μg | 2 | 55 | 2 |
| other | CONSTIPATION | Gastrointestinal disorders | IBS-C Participants: Linaclotide 290 μg | 0 | 53 | 0 |
| other | DIARRHOEA | Gastrointestinal disorders | FC Participants: Linaclotide 72 μg | 6 | 166 | 6 |
| other | DIARRHOEA | Gastrointestinal disorders | FC Participants: Placebo | 3 | 164 | 3 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | FC Participants: Linaclotide 72 μg | 0 | 166 |
| Total, all-cause mortality | FC Participants: Placebo | 0 | 164 |
| Total, all-cause mortality | IBS-C Participants: Linaclotide 145 μg | 0 | 55 |
| Total, all-cause mortality | IBS-C Participants: Linaclotide 290 μg | 0 | 53 |
| Total, other adverse events | FC Participants: Linaclotide 72 μg | 11 | 166 |
| Total, other adverse events | FC Participants: Placebo | 10 | 164 |
| Total, other adverse events | IBS-C Participants: Linaclotide 145 μg | 7 | 55 |
| Total, other adverse events | IBS-C Participants: Linaclotide 290 μg | 4 | 53 |
| Total, serious adverse events | FC Participants: Linaclotide 72 μg | 2 | 166 |
| Total, serious adverse events | FC Participants: Placebo | 2 | 164 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04026113
GET https://conductscience.org/api/trials/v1/NCT04026113/flow?page=2