Trial · NCT02291679
Trial of Linaclotide in Patients With Chronic Idiopathic Constipation
NCT02291679, Phase 3, Completed, Ironwood Pharmaceuticals, Inc.; results first posted 2017-05-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Trial of Linaclotide in Patients With Chronic Idiopathic Constipation. Trials, record NCT02291679. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02291679
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial of Linaclotide in Patients With Chronic Idiopathic Constipation
- NCT number
- NCT02291679
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,223 participants, actual
- Lead sponsor
- Ironwood Pharmaceuticals, Inc.
- Conditions
- Chronic Idiopathic Constipation
- Interventions
- Linaclotide, Matching Placebo
- First posted
- 2014-11-14
- Last updated
- 2017-06-15
- Results first posted
- 2017-05-19
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of 12-Week CSBM Overall Responders | Week 12 | A 12-week CSBM Overall Responder is a participant who was a CSBM Weekly Responder for at least 9 of the 12 weeks of the Treatment Period. A CSBM Weekly Responder is a participant who had a CSBM weekly frequency rate that was 3 or greater and increased by 1 or more from baseline, and completed ≥ 4 IVRS calls for the specified week. A CSBM is defined as an SBM that is associated with a sense of complete evacuation. An SBM is defined as a bowel movement BM that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM. |
| Secondary | Change From Baseline in 12-Week CSBM Frequency Rate | Baseline, Week 1 to Week 12 | A participant's 12-week CSBM Frequency Rate is the CSBM rate (CSBMs/week) calculated over the 12 weeks of the Treatment Period. A CSBM is defined as an SBM that is associated with a sense of complete evacuation. An SBM is defined as a BM that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM. |
| Secondary | Change From Baseline in 12-Week SBM Frequency Rate | Baseline, Week 1 to Week 12 | A participant's 12-week SBM Frequency Rate is the SBM rate (SBMs/week) calculated over the 12-weeks of the Treatment Period. An SBM is defined as a BM that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM. |
| Secondary | Change From Baseline in 12-Week Stool Consistency Score | Baseline, Week 1 to Week 12 | Stool consistency was measured daily using the 7-point ordinal Bristol Stool Form Scale (BSFS; 1 = separate hard lumps like nuts \[difficult to pass\]; 2 = sausage shaped but lumpy; 3 = like a sausage but with cracks on surface; 4 = like a sausage or snake, smooth and soft; 5 = soft blobs with clear-cut edges \[passed easily\]; 6 = fluffy pieces with ragged edges, a mushy stool; 7 = watery, no solid pieces \[entirely liquid\]). The participant's BSFS score for the Treatment Period is the average of the non-missing BSFS scores from the SBMs reported by the participant during the 12-week Treatment Period. |
| Secondary | Change From Baseline in 12-Week Straining Score | Baseline, Week 1 to Week 12 | Straining was measured daily using a 5-point ordinal scale (1 = not at all; 2 = a little bit; 3 = a moderate amount; 4 = a great deal; 5 = an extreme amount). The participant's straining score for the Treatment Period is the average of the non-missing straining scores from the SBMs reported by the participant during the 12-week Treatment Period. |
| Secondary | Percentage of 12-Week CSBM Overall Responders (>1 SBM/Week Subpopulation) | Week 12 | A 12-week CSBM Overall Responder is a participant who was a CSBM Weekly Responder for at least 9 of the 12 weeks of the Treatment Period. A CSBM Weekly Responder is a participant who had a CSBM weekly frequency rate that was 3 or greater and increased by 1 or more from baseline, and completed ≥4 IVRS calls for the specified week. A CSBM is defined as an SBM that is associated with a sense of complete evacuation. An SBM is defined as a BM that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM. |
| Secondary | Percentage of Month 1 CSBM Responders | Month 1 | A Month 1 CSBM Responder is a participant who is a CSBM weekly responder for at least 3 of the 4 weeks of Month 1 of the Treatment Period. A CSBM weekly responder is a participant who had a CSBM weekly frequency rate that was 3 or greater and increased by 1 or more from baseline based on a minimum of 4 complete IVRS calls for that week. A CSBM is defined as an SBM that is associated with a sense of complete evacuation. An SBM is defined as a BM that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM. |
| Secondary | Percentage of Month 2 CSBM Responders | Month 2 | A Month 2 CSBM Responder is a participant who is a CSBM weekly responder for at least 3 of the 4 weeks of Month 2 of the Treatment Period. A CSBM weekly responder is a participant who had a CSBM weekly frequency rate that was 3 or greater and increased by 1 or more from baseline based on a minimum of 4 complete IVRS calls for that week. A CSBM is defined as an SBM that is associated with a sense of complete evacuation. An SBM is defined as a BM that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM. |
| Secondary | Percentage of Month 3 CSBM Responders | Month 3 | A Month 3 CSBM Responder is a participant who is a CSBM weekly responder for at least 3 of the 4 weeks of Month 3 of the Treatment Period. A CSBM weekly responder is a participant who had a CSBM weekly frequency rate that was 3 or greater and increased by 1 or more from baseline based on a minimum of 4 complete IVRS calls for that week. A CSBM is defined as an SBM that is associated with a sense of complete evacuation. An SBM is defined as a BM that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM. |
| Secondary | Change From Baseline in 12-Week Abdominal Bloating | Baseline, Week 1 to Week 12 | Abdominal bloating was measured daily using an 11-point NRS (0 = none; 10 = very severe). The participant's abdominal bloating score for the Treatment Period is the average of the non-missing daily participant assessments of abdominal bloating scores reported during the 12-week Treatment Period. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of 12-Week CSBM Overall Responders | Week 12 | Intent-to-Treat Population: all randomized participants who received at least one dose of study drug. Only data for the 72 μg dose versus placebo arms were prospectively defined and evaluated as a primary endpoint; per protocol, data for the 145 μg dose arm were not collected for any pre-specified primary or secondary outcome measures. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in 12-Week CSBM Frequency Rate | Baseline, Week 1 to Week 12 | Intent-to-Treat Population: all randomized participants who received at least one dose of study drug. Only data for the 72 μg dose versus placebo arms were prospectively defined and evaluated as a secondary endpoint; data for the 145 μg dose arm were defined and evaluated as an additional endpoint per protocol. | CSBMs/week | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in 12-Week SBM Frequency Rate | Baseline, Week 1 to Week 12 | Intent-to-Treat Population: all randomized participants who received at least one dose of study drug. Only data for the 72 μg dose versus placebo arms were prospectively defined and evaluated as a secondary endpoint; data for the 145 μg dose arm were defined and evaluated as an additional endpoint per protocol. | SBMs/week | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in 12-Week Stool Consistency Score | Baseline, Week 1 to Week 12 | Intent-to-Treat Population: all randomized participants who received ≥ 1 dose of study drug and reported an SBM during the Baseline period. Only data for the 72 μg dose versus placebo arms were prospectively defined and evaluated as a secondary endpoint; data for the 145 μg dose arm were defined and evaluated as an additional endpoint per protocol. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in 12-Week Straining Score | Baseline, Week 1 to Week 12 | Intent-to-Treat Population: all randomized participants who received ≥ 1 dose of study drug and reported an SBM during the Baseline period. Only data for the 72 μg dose versus placebo arms were prospectively defined and evaluated as a secondary endpoint; data for the 145 μg dose arm were defined and evaluated as an additional endpoint per protocol. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of 12-Week CSBM Overall Responders (>1 SBM/Week Subpopulation) | Week 12 | Participants in the Intent-to-Treat Population who reported \>1 SBM/week during the Pretreatment Period (14 days prior to randomization). Only data for the 72 μg dose versus placebo arms were prospectively defined and evaluated as a secondary endpoint; data for the 145 μg dose arm were defined and evaluated as an additional endpoint per protocol. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Month 1 CSBM Responders | Month 1 | Intent-to-Treat Population: all randomized participants who received at least one dose of study drug. Only data for the 72 μg dose versus placebo arms were prospectively defined and evaluated as a secondary endpoint; data for the 145 μg dose arm were defined and evaluated as an additional endpoint per protocol. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Month 2 CSBM Responders | Month 2 | Intent-to-Treat Population: all randomized participants who received at least one dose of study drug. Only data for the 72 μg dose versus placebo arms were prospectively defined and evaluated as a secondary endpoint; data for the 145 μg dose arm were defined and evaluated as an additional endpoint per protocol. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Month 3 CSBM Responders | Month 3 | Intent-to-Treat Population: all randomized participants who received at least one dose of study drug. Only data for the 72 μg dose versus placebo arms were prospectively defined and evaluated as a secondary endpoint; data for the 145 μg dose arm were defined and evaluated as an additional endpoint per protocol. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in 12-Week Abdominal Bloating | Baseline, Week 1 to Week 12 | Intent-to-Treat Population: all randomized participants who received at least one dose of study drug. Only data for the 72 μg dose versus placebo arms were prospectively defined and evaluated as a secondary endpoint; data for the 145 μg dose arm were defined and evaluated as an additional endpoint per protocol. | units on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of 12-Week CSBM Overall Responders | Placebo | Responder | 4.7 | percentage of participants | |
| Percentage of 12-Week CSBM Overall Responders | 72 μg Linaclotide | Responder | 13.4 | percentage of participants | |
| Percentage of 12-Week CSBM Overall Responders | Placebo | Non-Responder | 95.3 | percentage of participants | |
| Percentage of 12-Week CSBM Overall Responders | 72 μg Linaclotide | Non-Responder | 86.6 | percentage of participants | |
| Change From Baseline in 12-Week CSBM Frequency Rate | Placebo | 0.884 | Standard Error 0.142 | CSBMs/week | |
| Change From Baseline in 12-Week CSBM Frequency Rate | 72 μg Linaclotide | 1.725 | Standard Error 0.139 | CSBMs/week | |
| Change From Baseline in 12-Week SBM Frequency Rate | Placebo | 1.329 | Standard Error 0.169 | SBMs/week | |
| Change From Baseline in 12-Week SBM Frequency Rate | 72 μg Linaclotide | 2.366 | Standard Error 0.166 | SBMs/week | |
| Change From Baseline in 12-Week Stool Consistency Score | Placebo | 1.065 | Standard Error 0.076 | units on a scale | |
| Change From Baseline in 12-Week Stool Consistency Score | 72 μg Linaclotide | 1.693 | Standard Error 0.074 | units on a scale |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 401 | |
| Overall Study | STARTED | 72 μg Linaclotide | 411 | |
| Overall Study | STARTED | 145 μg Linaclotide | 411 | |
| Overall Study | COMPLETED | Placebo | 357 | |
| Overall Study | COMPLETED | 72 μg Linaclotide | 369 | |
| Overall Study | COMPLETED | 145 μg Linaclotide | 352 | |
| Overall Study | NOT COMPLETED | Placebo | 44 | |
| Overall Study | NOT COMPLETED | 72 μg Linaclotide | 42 | |
| Overall Study | NOT COMPLETED | 145 μg Linaclotide | 59 |
Source ClinicalTrials.gov
Adverse events30
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 | Diarrhea | Gastrointestinal disorders | Placebo | 28 | 401 | |
| other | Diarrhea | Gastrointestinal disorders | 72 μg Linaclotide | 79 | 411 | |
| other | Diarrhea | Gastrointestinal disorders | 145 μg Linaclotide | 91 | 411 | |
| serious | Colitis | Gastrointestinal disorders | Placebo | 0 | 401 | |
| serious | Colitis | Gastrointestinal disorders | 72 μg Linaclotide | 1 | 411 | |
| serious | Colitis | Gastrointestinal disorders | 145 μg Linaclotide | 1 | 411 | |
| serious | Diabetes mellitus inadequate control | Metabolism and nutrition disorders | Placebo | 0 | 401 | |
| serious | Diabetes mellitus inadequate control | Metabolism and nutrition disorders | 72 μg Linaclotide | 0 | 411 | |
| serious | Diabetes mellitus inadequate control | Metabolism and nutrition disorders | 145 μg Linaclotide | 1 | 411 | |
| serious | Asthma | Respiratory, thoracic and mediastinal disorders | Placebo | 1 | 401 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | 72 μg Linaclotide | ||
| Total, all-cause mortality | 145 μg Linaclotide | ||
| Total, other adverse events | Placebo | 28 | 401 |
| Total, other adverse events | 72 μg Linaclotide | 79 | 411 |
| Total, other adverse events | 145 μg Linaclotide | 91 | 411 |
| Total, serious adverse events | Placebo | 4 | 401 |
| Total, serious adverse events | 72 μg Linaclotide | 3 | 411 |
| Total, serious adverse events | 145 μg Linaclotide | 2 | 411 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT02291679
GET https://conductscience.org/api/trials/v1/NCT02291679/results?page=2