Trial · NCT00547898

Safety and Effectiveness of 3 Doses of Crofelemer Compared to Placebo in the Treatment of HIV Associated Diarrhea

NCT00547898, Phase 3, Completed, Bausch Health Americas, Inc.; results first posted 2020-09-03

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Effectiveness of 3 Doses of Crofelemer Compared to Placebo in the Treatment of HIV Associated Diarrhea. Trials, record NCT00547898. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00547898

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Safety and Effectiveness of 3 Doses of Crofelemer Compared to Placebo in the Treatment of HIV Associated Diarrhea
NCT number: NCT00547898
Status: Completed
Phases: Phase 3
Enrollment: 374 participants, actual
Lead sponsor: Bausch Health Americas, Inc.
Conditions: HIV Associated Diarrhea
Interventions: Crofelemer 125 mg, Crofelemer 250 mg, Crofelemer 500 mg, Placebo
First posted: 2007-10-23
Last updated: 2020-09-03
Results first posted: 2020-09-03

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	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	31 days
Other	Percentage of Participants Experiencing Relief of Diarrhea	31 days	Relief of diarrhea was defined as two or less watery bowel movements per week during at least two weeks of the treatment phase.

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	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	31 days	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.	Participants	COUNT_OF_PARTICIPANTS
OTHER_PRE_SPECIFIED	Percentage of Participants Experiencing Relief of Diarrhea	31 days		Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
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	Crofelemer 125Mg BID	24	Participants
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	Placebo BID	11	Participants
Percentage of Participants Experiencing Relief of Diarrhea	Placebo	11	Participants
Percentage of Participants Experiencing Relief of Diarrhea	Crofelemer 125 mg	24	Participants
Percentage of Participants Experiencing Relief of Diarrhea	Crofelemer 250 mg	5	Participants
Percentage of Participants Experiencing Relief of Diarrhea	Crofelemer 500 mg	9	Participants

Source ClinicalTrials.gov

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	138
Overall Study	STARTED	Crofelemer 125 mg	136
Overall Study	STARTED	Crofelemer 250 mg	54
Overall Study	STARTED	Crofelemer 500 mg	46
Overall Study	COMPLETED	Placebo	129
Overall Study	COMPLETED	Crofelemer 125 mg	126
Overall Study	COMPLETED	Crofelemer 250 mg	54
Overall Study	COMPLETED	Crofelemer 500 mg	40
Overall Study	NOT COMPLETED	Placebo	9
Overall Study	NOT COMPLETED	Crofelemer 125 mg	10

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events20

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
serious	PANCREATITIS ACUTE	Gastrointestinal disorders	Placebo	1	137
serious	PANCREATITIS ACUTE	Gastrointestinal disorders	Crofelemer 125 mg	0	130
serious	PANCREATITIS ACUTE	Gastrointestinal disorders	Crofelemer 250 mg	0	54
serious	PANCREATITIS ACUTE	Gastrointestinal disorders	Crofelemer 500 mg	0	42
serious	ESCHERICHIA SEPSIS	Infections and infestations	Placebo	0	137
serious	ESCHERICHIA SEPSIS	Infections and infestations	Crofelemer 125 mg	1	130
serious	ESCHERICHIA SEPSIS	Infections and infestations	Crofelemer 250 mg	0	54
serious	ESCHERICHIA SEPSIS	Infections and infestations	Crofelemer 500 mg	0	42
serious	PNEUMONIA	Infections and infestations	Placebo	1	137
serious	PNEUMONIA	Infections and infestations	Crofelemer 125 mg	1	130

1 to 10 of 20Source ClinicalTrials.gov

See all 20 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo
Total, all-cause mortality	Crofelemer 125 mg
Total, all-cause mortality	Crofelemer 250 mg
Total, all-cause mortality	Crofelemer 500 mg
Total, other adverse events	Placebo	0	137
Total, other adverse events	Crofelemer 125 mg	0	130
Total, other adverse events	Crofelemer 250 mg	0	54
Total, other adverse events	Crofelemer 500 mg	0	42
Total, serious adverse events	Placebo	4	137
Total, serious adverse events	Crofelemer 125 mg	2	130

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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 comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
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

Source 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT00547898

GET https://conductscience.org/api/trials/v1/NCT00547898/registered

API reference For AI assistants