Comparison · NCT02544152-b4638694
Lubiprostone vs Placebo: Number of Participants Classified as an Overall Responder for Abdominal Pain
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Lubiprostone vs Placebo: Number of Participants Classified as an Overall Responder for Abdominal Pain. Trial comparisons, record NCT02544152-b4638694. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02544152-b4638694
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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 | 0.297 | 0.175 | 0.458 | wilson | |
| Risk in group 2 | 0.294 | 0.168 | 0.462 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00318 | -0.204 | 0.207 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.01 | 0.493 | 2.07 | log | |
| Odds ratio, group 1 over group 2 | 1.02 | 0.366 | 2.82 | log | |
| Number needed to treat, for one more participant with the outcome on Lubiprostone than on Placebo | 314 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Lubiprostone | Participants receive 8 mcg lubiprostone capsules BID | 11 | 37 | OG001 |
| Group 2 | Placebo | Participants receive 0 mcg capsules twice daily (BID) | 10 | 34 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants Classified as an Overall Responder for Abdominal Pain
- Description
- An overall responder for abdominal pain is defined as a participant who is a weekly responder for at least 75% of observed treatment weeks.
- Time frame
- within 12 weeks
- Population
- modified Intent to Treat (mITT), defined as all randomized subjects who take at least one dose of study medication.
Source ClinicalTrials.gov
Trial
- Title
- Evaluation of the Efficacy and Safety of Lubiprostone in Adults With Mixed or Unsubtyped Irritable Bowel Syndrome
- NCT number
- NCT02544152
- Phases
- PHASE2
- Conditions
- Irritable Bowel Syndrome
- Interventions
- Lubiprostone, Placebo
- Lead sponsor
- Sucampo Pharma Americas, LLC
- Results first posted
- 2019-12-27
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02544152?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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