Trial · NCT00938717
Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
NCT00938717, Phase 3, Completed, Ironwood Pharmaceuticals, Inc.; results first posted 2013-01-30
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 NCT00938717. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00938717
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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
- NCT00938717
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 805 participants, actual
- Lead sponsor
- Ironwood Pharmaceuticals, Inc.
- Conditions
- Irritable Bowel Syndrome With Constipation
- Interventions
- Linaclotide or Matching Placebo
- First posted
- 2009-07-14
- Last updated
- 2013-11-05
- Results first posted
- 2013-01-30
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder, 9 Out of 12 Weeks | Change from Baseline to Week 12 | A patient is considered to be a 9 out of 12 week APC responder if, for at least 9 out of the first 12 weeks of the treatment period, the patient had at least 3 CSBMs, had an increase of at least 1 CSBM from baseline, and had a decrease of at least 30 percent in their Abdominal Pain (AP) score from baseline during a particular week. The AP score assesses patient's worst AP in the past 24 hours using an 11-point scale (from 0-10), where 0 represents no AP and 10 represents very severe AP. SBM is defined as a bowel movement that occurs in the absence of laxative, enema, or suppository use on either the calendar day of the bowel movement or the calendar day before the bowel movement. CSBM is defined as an SBM associated with a sense of complete evacuation. |
| Primary | Complete Spontaneous Bowel Movement (CSBM) 3+1 Responder, 9 Out of 12 Weeks | Change from Baseline to Week 12 | A patient is considered to be a CSBM 3+1 responder if, for at least 9 out of the 12 weeks of the treatment period, the patient had at least 3 CSBMs and experienced an increase of at least 1 CSBM from baseline during a particular week. A CSBM was defined as a Spontaneous Bowel Movement (SBM) that was associated with a sense of complete evacuation. An SBM was 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. |
| Primary | Abdominal Pain Responder, 9 Out of 12 Weeks | Change from Baseline to Week 12 | A patient is considered to be an abdominal pain responder if, for at least 9 out of the 12 weeks of the treatment period, they experienced a decrease of at least 30 percent in the mean abdominal pain score from baseline during a particular week. The Abdominal Pain score assesses patient's worst abdominal pain in the past 24 hours using an 11-point scale (from 0-10), where 0 represents no abdominal pain and 10 represents very severe abdominal pain. |
| Primary | Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder, 6 Out of 12 Weeks | Change from Baseline to Week 12 | A patient is considered to be a 6 out of 12 week APC responder if, for at least 6 out of the first 12 weeks of the treatment period, the patient had an increase of at least 1 CSBM from baseline, and had a decrease of at least 30 percent in their Abdominal Pain (AP) score from baseline during a particular week. The AP score assesses patient's worst AP in the past 24 hours using an 11-point scale (from 0-10), where 0 represents no AP and 10 represents very severe AP. SBM is defined as a bowel movement that occurs in the absence of laxative, enema, or suppository use on either the calendar day of the bowel movement or the calendar day before the bowel movement. CSBM is defined as an SBM associated with a sense of complete evacuation. |
| Secondary | 12-Week Complete Spontaneous Bowel Movement (CSBM) Frequency | Change from Baseline to Week 12 | The change from baseline in 12-week CSBM frequency (i.e., weekly CSBM frequency over the first 12 weeks of the Treatment Period). |
| Secondary | 12-Week Spontaneous Bowl Movement (SBM) Frequency | Change from Baseline to Week 12 | The change from baseline in 12-week SBM frequency (i.e., weekly SBM frequency over the first 12 weeks of the Treatment Period). |
| Secondary | 12-Week Change in Stool Consistency | Change from Baseline to Week 12 | The consistency of each BM was assessed by patients using the 7-point Bristol Stool Form Scale (BSFS) from 1 to 7. 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 \[entirely liquid\]). |
| Secondary | 12-Week Change in Severity of Straining | Change from Baseline to Week 12 | Straining is measured on a 5-point scale where a value of 1 is "not at all" and a value of 5 is "an extreme amount". |
| Secondary | 12-Week Change in Abdominal Pain Score | Change from Baseline to Week 12 | Abdominal Pain at its worst (in the last 24 hours) is based on an 11-point scale where 0 represents no abdominal pain and 10 represents very severe abdominal pain. |
| Secondary | 12-Week Change in Abdominal Discomfort | Change from Baseline to Week 12 | Abdominal discomfort was assessed on an 11-point scale where a value of 0 is "none" and a value of 10 is "very severe". |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder, 9 Out of 12 Weeks | Change from Baseline to Week 12 | 805 patients were randomized to treatment. 804 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the Intent to Treat (ITT) Population. An observed-cases approach to missing postbaseline data was applied. | participants | NUMBER |
| PRIMARY | Complete Spontaneous Bowel Movement (CSBM) 3+1 Responder, 9 Out of 12 Weeks | Change from Baseline to Week 12 | 805 patients were randomized to treatment. 804 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied. | participants | NUMBER |
| PRIMARY | Abdominal Pain Responder, 9 Out of 12 Weeks | Change from Baseline to Week 12 | 805 patients were randomized to treatment. 804 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied. | participants | NUMBER |
| PRIMARY | Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder, 6 Out of 12 Weeks | Change from Baseline to Week 12 | 805 patients were randomized to treatment. 804 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied. | participants | NUMBER |
| SECONDARY | 12-Week Complete Spontaneous Bowel Movement (CSBM) Frequency | Change from Baseline to Week 12 | 805 patients were randomized to treatment. 804 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied. | CSBMs per Week | LEAST_SQUARES_MEAN |
| SECONDARY | 12-Week Spontaneous Bowl Movement (SBM) Frequency | Change from Baseline to Week 12 | 805 patients were randomized to treatment. 804 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied. | SBMs per Week | LEAST_SQUARES_MEAN |
| SECONDARY | 12-Week Change in Stool Consistency | Change from Baseline to Week 12 | 805 patients were randomized to treatment; 804 patients had at least 1 postrandomization entry of the primary efficacy assessment and included in the ITT Population; 134 patients with no pretreatment spontaneous bowel movements were excluded from the Stool Consistency analysis. An observed-cases approach to missing postbaseline data was applied. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | 12-Week Change in Severity of Straining | Change from Baseline to Week 12 | 805 patients were randomized to treatment; 804 patients had at least 1 postrandomization entry of the primary efficacy assessment and included in the ITT Population; 134 patients with no pretreatment spontaneous bowel movements were excluded from the Straining analysis. An observed-cases approach to missing postbaseline data was applied. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | 12-Week Change in Abdominal Pain Score | Change from Baseline to Week 12 | 805 patients were randomized to treatment. 804 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | 12-Week Change in Abdominal Discomfort | Change from Baseline to Week 12 | 805 patients were randomized to treatment. 804 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied. | Units on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder, 9 Out of 12 Weeks | Placebo | 12 | participants | ||
| Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder, 9 Out of 12 Weeks | Linaclotide | 51 | participants | ||
| Complete Spontaneous Bowel Movement (CSBM) 3+1 Responder, 9 Out of 12 Weeks | Placebo | 20 | participants | ||
| Complete Spontaneous Bowel Movement (CSBM) 3+1 Responder, 9 Out of 12 Weeks | Linaclotide | 72 | participants | ||
| Abdominal Pain Responder, 9 Out of 12 Weeks | Placebo | 79 | participants | ||
| Abdominal Pain Responder, 9 Out of 12 Weeks | Linaclotide | 156 | participants | ||
| Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder, 6 Out of 12 Weeks | Placebo | 56 | participants | ||
| Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder, 6 Out of 12 Weeks | Linaclotide | 135 | participants | ||
| 12-Week Complete Spontaneous Bowel Movement (CSBM) Frequency | Placebo | 0.70 | Standard Error 0.12 | CSBMs per Week | |
| 12-Week Complete Spontaneous Bowel Movement (CSBM) Frequency | Linaclotide | 2.24 | Standard Error 0.12 | CSBMs per Week |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 403 | |
| Overall Study | STARTED | Linaclotide | 402 | |
| Overall Study | COMPLETED | Placebo | 305 | |
| Overall Study | COMPLETED | Linaclotide | 294 | |
| Overall Study | NOT COMPLETED | Placebo | 98 | |
| Overall Study | NOT COMPLETED | Linaclotide | 108 |
Source ClinicalTrials.gov
Adverse events34
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 | 10 | 403 | |
| other | Diarrhea | Gastrointestinal disorders | Linaclotide | 79 | 402 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 24 | 403 | |
| other | Nausea | Gastrointestinal disorders | Linaclotide | 23 | 402 | |
| other | Sinusitis | Infections and infestations | Placebo | 28 | 403 | |
| other | Sinusitis | Infections and infestations | Linaclotide | 23 | 402 | |
| other | Upper respiratory tract infection | Infections and infestations | Placebo | 22 | 403 | |
| other | Upper respiratory tract infection | Infections and infestations | Linaclotide | 22 | 402 | |
| other | Urinary tract infection | Infections and infestations | Placebo | 22 | 403 | |
| other | Urinary tract infection | Infections and infestations | Linaclotide | 17 | 402 |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Linaclotide | ||
| Total, other adverse events | Placebo | 86 | 403 |
| Total, other adverse events | Linaclotide | 137 | 402 |
| Total, serious adverse events | Placebo | 7 | 403 |
| Total, serious adverse events | Linaclotide | 4 | 402 |
Source ClinicalTrials.gov
Papers2
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 comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Linaclotide vs Placebo: Abdominal Pain Responder, 9 Out of 12 Weeks | Trial comparisons |
| Linaclotide vs Placebo: Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder, 6 Out of 12 Weeks | Trial comparisons |
| Linaclotide vs Placebo: Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder, 9 Out of 12 Weeks | Trial comparisons |
| Linaclotide vs Placebo: Abdominal Pain Responder for 6 Out of 12 Weeks | Trial comparisons |
| Linaclotide vs Placebo: Complete Spontaneous Bowl Movement (CSBM) Responder for 6 Weeks Out of 12 Weeks of Treatment | Trial comparisons |
| Linaclotide vs Placebo: Complete Spontaneous Bowel Movement (CSBM) 3+1 Responder, 9 Out of 12 Weeks | Trial comparisons |
| Linaclotide 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
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/NCT00938717
GET https://conductscience.org/api/trials/v1/NCT00938717/results?page=2