Trial · NCT02559206
Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
NCT02559206, Phase 2, Completed, Ironwood Pharmaceuticals, Inc.; results first posted 2020-04-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C). Trials, record NCT02559206. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02559206
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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 Irritable Bowel Syndrome With Constipation (IBS-C)
- NCT number
- NCT02559206
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 759 participants, actual
- Lead sponsor
- Ironwood Pharmaceuticals, Inc.
- Conditions
- Irritable Bowel Syndrome With Constipation
- Interventions
- Linaclotide, Matching Placebo
- First posted
- 2015-09-24
- Last updated
- 2020-04-24
- Results first posted
- 2020-04-24
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Weekly Abdominal Pain Score Over the 12-Week Treatment Period: DR1 or IR vs. Placebo | Baseline, up to Week 12 | Abdominal pain assessment was based on an 11-point numerical rating scale (0=No symptom; 10=Worst possible) assessing the symptom "at its worst in past 24 hours." A participant's weekly abdominal pain score is the average of the nonmissing abdominal pain scores reported by the participant during each week. |
| Primary | Change From Baseline in Weekly Abdominal Pain Score Over the 12-Week Treatment Period: DR2 or IR vs. Placebo | Baseline, up to Week 12 | Abdominal pain assessment was based on an 11-point numerical rating scale (0=No symptom; 10=Worst possible) assessing the symptom "at its worst in past 24 hours." A participant's weekly abdominal pain score is the average of the nonmissing abdominal pain scores reported by the participant during each week. |
| Primary | Change From Baseline in Weekly CSBM Frequency Rate Over the 12-Week Treatment Period: DR1 or IR vs. Placebo | Baseline, up to Week 12 | A participant's weekly CSBM frequency rate is the CSBM rate (CSBMs/week) calculated over that week. |
| Primary | Change From Baseline in Weekly CSBM Frequency Rate Over the 12-Week Treatment Period: DR2 or IR vs. Placebo | Baseline, up to Week 12 | A participant's weekly CSBM frequency rate is the CSBM rate (CSBMs/week) calculated over that week. |
| Primary | Number of 6/12 Week Abdominal Pain and Constipation (APC) +1 Responders Over the 12-Week Treatment Period: DR1 or IR vs. Placebo | up to Week 12 | A 6/12 Week APC +1 Responder is a participant who meets the Weekly APC +1 Responder criteria for at least 6 out of the 12 weeks of the Treatment Period. * Weekly APC +1 Responder: A participant who meets the criteria to be a Weekly Abdominal Pain Responder and a Weekly CSBM +1 Responder. * Weekly Abdominal Pain Responder: A participant who has a decrease from baseline of ≥30% in the mean daily worst abdominal pain scores for that week. * Weekly CSBM +1 Responder: A participant who has an increase from baseline of ≥1 in the CSBM weekly rate for that week. A participant with \<4 days of completed eDiary data for that week is not considered a responder for that week. |
| Primary | Number of 6/12 Week Abdominal Pain and Constipation (APC) +1 Responders Over the 12-Week Treatment Period: DR2 or IR vs. Placebo | up to Week 12 | A 6/12 Week APC +1 Responder is a participant who meets the Weekly APC +1 Responder criteria for at least 6 out of the 12 weeks of the Treatment Period. * Weekly APC +1 Responder: A participant who meets the criteria to be a Weekly Abdominal Pain Responder and a Weekly CSBM +1 Responder. * Weekly Abdominal Pain Responder: A participant who has a decrease from baseline of ≥30% in the mean daily worst abdominal pain scores for that week. * Weekly CSBM +1 Responder: A participant who has an increase from baseline of ≥1 in the CSBM weekly rate for that week. A participant with \<4 days of completed eDiary data for that week is not considered a responder for that week. |
Source ClinicalTrials.gov
Outcomes6
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 Weekly Abdominal Pain Score Over the 12-Week Treatment Period: DR1 or IR vs. Placebo | Baseline, up to Week 12 | Intent to Treat Population: all randomized participants who received at least one dose of study drug (evaluated according to assigned treatment). | score on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline in Weekly Abdominal Pain Score Over the 12-Week Treatment Period: DR2 or IR vs. Placebo | Baseline, up to Week 12 | Intent to Treat Population: all randomized participants who received at least one dose of study drug (evaluated according to assigned treatment). | score on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline in Weekly CSBM Frequency Rate Over the 12-Week Treatment Period: DR1 or IR vs. Placebo | Baseline, up to Week 12 | Intent to Treat Population: all randomized participants who received at least one dose of study drug (evaluated according to assigned treatment). | CSBMs/week | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline in Weekly CSBM Frequency Rate Over the 12-Week Treatment Period: DR2 or IR vs. Placebo | Baseline, up to Week 12 | Intent to Treat Population: all randomized participants who received at least one dose of study drug (evaluated according to assigned treatment). | CSBMs/week | LEAST_SQUARES_MEAN |
| PRIMARY | Number of 6/12 Week Abdominal Pain and Constipation (APC) +1 Responders Over the 12-Week Treatment Period: DR1 or IR vs. Placebo | up to Week 12 | Intent to Treat Population: all randomized participants who received at least one dose of study drug (evaluated according to assigned treatment). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of 6/12 Week Abdominal Pain and Constipation (APC) +1 Responders Over the 12-Week Treatment Period: DR2 or IR vs. Placebo | up to Week 12 | Intent to Treat Population: all randomized participants who received at least one dose of study drug (evaluated according to assigned treatment). | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group40
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 Weekly Abdominal Pain Score Over the 12-Week Treatment Period: DR1 or IR vs. Placebo | Placebo | -1.370 | Standard Error 0.241 | score on a scale | |
| Change From Baseline in Weekly Abdominal Pain Score Over the 12-Week Treatment Period: DR1 or IR vs. Placebo | Linaclotide IR 290 μg | -1.938 | Standard Error 0.241 | score on a scale | |
| Change From Baseline in Weekly Abdominal Pain Score Over the 12-Week Treatment Period: DR1 or IR vs. Placebo | Linaclotide DR1 30 μg | -1.667 | Standard Error 0.234 | score on a scale | |
| Change From Baseline in Weekly Abdominal Pain Score Over the 12-Week Treatment Period: DR1 or IR vs. Placebo | Linaclotide DR1 100 μg | -1.656 | Standard Error 0.240 | score on a scale | |
| Change From Baseline in Weekly Abdominal Pain Score Over the 12-Week Treatment Period: DR1 or IR vs. Placebo | Linaclotide DR1 300 μg | -2.140 | Standard Error 0.236 | score on a scale | |
| Change From Baseline in Weekly Abdominal Pain Score Over the 12-Week Treatment Period: DR2 or IR vs. Placebo | Placebo | -1.370 | Standard Error 0.241 | score on a scale | |
| Change From Baseline in Weekly Abdominal Pain Score Over the 12-Week Treatment Period: DR2 or IR vs. Placebo | Linaclotide IR 290 μg | -1.938 | Standard Error 0.241 | score on a scale | |
| Change From Baseline in Weekly Abdominal Pain Score Over the 12-Week Treatment Period: DR2 or IR vs. Placebo | Linaclotide DR2 30 μg | -1.825 | Standard Error 0.238 | score on a scale | |
| Change From Baseline in Weekly Abdominal Pain Score Over the 12-Week Treatment Period: DR2 or IR vs. Placebo | Linaclotide DR2 100 μg | -1.669 | Standard Error 0.235 | score on a scale | |
| Change From Baseline in Weekly Abdominal Pain Score Over the 12-Week Treatment Period: DR2 or IR vs. Placebo | Linaclotide DR2 300 μg | -1.628 | Standard Error 0.239 | score on a scale |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 66 | |
| Overall Study | STARTED | Linaclotide IR 290 μg | 66 | |
| Overall Study | STARTED | Linaclotide DR1 30 μg | 67 | |
| Overall Study | STARTED | Linaclotide DR1 100 μg | 67 | |
| Overall Study | STARTED | Linaclotide DR1 300 μg | 67 | |
| Overall Study | STARTED | Linaclotide DR2 30 μg | 67 | |
| Overall Study | STARTED | Linaclotide DR2 100 μg | 66 | |
| Overall Study | STARTED | Linaclotide DR2 300 μg | 66 | |
| Overall Study | COMPLETED | Placebo | 58 | |
| Overall Study | COMPLETED | Linaclotide IR 290 μg | 54 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events40
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 | 1 | 66 | |
| other | Diarrhea | Gastrointestinal disorders | Linaclotide IR 290 μg | 9 | 66 | |
| other | Diarrhea | Gastrointestinal disorders | Linaclotide DR1 30 μg | 2 | 67 | |
| other | Diarrhea | Gastrointestinal disorders | Linaclotide DR1 100 μg | 5 | 67 | |
| other | Diarrhea | Gastrointestinal disorders | Linaclotide DR1 300 μg | 7 | 67 | |
| other | Diarrhea | Gastrointestinal disorders | Linaclotide DR2 30 μg | 0 | 67 | |
| other | Diarrhea | Gastrointestinal disorders | Linaclotide DR2 100 μg | 1 | 66 | |
| other | Diarrhea | Gastrointestinal disorders | Linaclotide DR2 300 μg | 2 | 66 | |
| other | Headache | Nervous system disorders | Placebo | 0 | 66 | |
| other | Headache | Nervous system disorders | Linaclotide IR 290 μg | 1 | 66 |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 66 |
| Total, all-cause mortality | Linaclotide IR 290 μg | 0 | 66 |
| Total, all-cause mortality | Linaclotide DR1 30 μg | 0 | 67 |
| Total, all-cause mortality | Linaclotide DR1 100 μg | 0 | 67 |
| Total, all-cause mortality | Linaclotide DR1 300 μg | 0 | 67 |
| Total, all-cause mortality | Linaclotide DR2 30 μg | 0 | 67 |
| Total, all-cause mortality | Linaclotide DR2 100 μg | 0 | 66 |
| Total, all-cause mortality | Linaclotide DR2 300 μg | 0 | 66 |
| Total, other adverse events | Placebo | 1 | 66 |
| Total, other adverse events | Linaclotide IR 290 μg | 10 | 66 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33065589 | 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 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/NCT02559206
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