Comparison · NCT00547898-4b5eba95
Crofelemer 125Mg BID vs Placebo BID: Primary Efficacy Outcome is Count of Participants With Two or Less Watery Bowel Movements Per Week During at Least Two Weeks of the Treatment Phase of the Optimal Dose of Crofelemer Compared to Placebo
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. Crofelemer 125Mg BID vs Placebo BID: Primary Efficacy Outcome is Count of Participants With Two or Less Watery Bowel Movements Per Week During at Least Two Weeks of the Treatment Phase of the Optimal Dose of Crofelemer Compared to Placebo. Trial comparisons, record NCT00547898-4b5eba95. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00547898-4b5eba95
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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 | 0.176 | 0.122 | 0.249 | wilson | |
| Risk in group 2 | 0.0797 | 0.0451 | 0.137 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0968 | 0.0173 | 0.177 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.21 | 1.13 | 4.34 | log | |
| Odds ratio, group 1 over group 2 | 2.47 | 1.16 | 5.28 | log | |
| Number needed to treat, for one more participant with the outcome on Crofelemer 125Mg BID than on Placebo BID | 10.3 | 5.64 | 57.7 | 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 | Crofelemer 125Mg BID | 24 | 136 | OG000 | |
| Group 2 | Placebo BID | 11 | 138 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
Primary Efficacy Outcome is Count of Participants With Two or Less Watery Bowel Movements Per Week During at Least Two Weeks of the Treatment Phase of the Optimal Dose of Crofelemer Compared to Placebo
- Description
- Time frame
- 31 days
- Population
The primary efficacy analysis was pre-specified to be for the optimal dose of crofelemer compared to placebo. Crofelemer 125 mg BID group was selected as the optimal dose. Since other doses of crofelemer were not considered to be the optimal dose, they are not included in the analysis.
Source ClinicalTrials.gov
Trial
- Title
- Safety and Effectiveness of 3 Doses of Crofelemer Compared to Placebo in the Treatment of HIV Associated Diarrhea
- NCT number
- NCT00547898
- Phases
- PHASE3
- Conditions
- HIV Associated Diarrhea
- Interventions
- Crofelemer 125 mg, Crofelemer 250 mg, Crofelemer 500 mg, Placebo
- Lead sponsor
- Bausch Health Americas, Inc.
- Results first posted
- 2020-09-03
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00547898?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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