Comparison · NCT00938717-e5ab9086
Linaclotide vs Placebo: Complete Spontaneous Bowl Movement (CSBM) Responder for 6 Weeks Out of 12 Weeks of Treatment
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: Complete Spontaneous Bowl Movement (CSBM) Responder for 6 Weeks Out of 12 Weeks of Treatment. Trial comparisons, record NCT00938717-e5ab9086. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00938717-e5ab9086
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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 | 0.476 | 0.428 | 0.525 | wilson | |
| Risk in group 2 | 0.226 | 0.188 | 0.269 | wilson | |
| Risk difference, group 1 minus group 2 | 0.251 | 0.186 | 0.312 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.11 | 1.71 | 2.6 | log | |
| Odds ratio, group 1 over group 2 | 3.12 | 2.3 | 4.23 | log | |
| Number needed to treat, for one more participant with the outcome on Linaclotide than on Placebo | 3.99 | 3.2 | 5.39 | 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. | 191 | 401 | OG001 |
| Group 2 | Placebo | Dose-matched placebo, oral administration, once per day. | 91 | 403 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Complete Spontaneous Bowl Movement (CSBM) Responder for 6 Weeks Out of 12 Weeks of Treatment
- Description
- A patient is considered to be a CSBM responder if, for at least 6 out of the 12 weeks of the treatment period, an increase of at least 1 CSBM per week from baseline was experienced.
- 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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