Comparison · NCT00938717-29f0fc59
Linaclotide vs Placebo: Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder, 6 Out of 12 Weeks
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Linaclotide vs Placebo: Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder, 6 Out of 12 Weeks. Trial comparisons, record NCT00938717-29f0fc59. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00938717-29f0fc59
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.337 | 0.292 | 0.384 | wilson | |
| Risk in group 2 | 0.139 | 0.109 | 0.176 | wilson | |
| Risk difference, group 1 minus group 2 | 0.198 | 0.14 | 0.254 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.42 | 1.83 | 3.2 | log | |
| Odds ratio, group 1 over group 2 | 3.14 | 2.22 | 4.46 | log | |
| Number needed to treat, for one more participant with the outcome on Linaclotide than on Placebo | 5.06 | 3.93 | 7.16 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Linaclotide | Linaclotide 290μg, oral administration, once per day. | 135 | 401 | OG001 |
| Group 2 | Placebo | Dose-matched placebo, oral administration, once per day. | 56 | 403 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder, 6 Out of 12 Weeks
- Description
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.
- Time frame
- Change from Baseline to Week 12
- Population
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.
Source ClinicalTrials.gov
Trial
- Title
- Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
- NCT number
- NCT00938717
- Phases
- PHASE3
- Conditions
- Irritable Bowel Syndrome With Constipation
- Interventions
- Linaclotide or Matching Placebo
- Lead sponsor
- Ironwood Pharmaceuticals, Inc.
- Results first posted
- 2013-01-30
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00938717?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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