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| Descriptive Information Fields | |||||||||
| Brief Title † | Safety and Effectiveness of 3 Doses of Crofelemer Compared to Placebo in the Treatment of HIV Associated Diarrhea | ||||||||
| Official Title † | Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Two-Stage Study to Assess the Efficacy and Safety of 3 Doses of Crofelemer Orally Twice Daily for the Treatment of HIV-Associated Diarrhea | ||||||||
| Brief Summary | This is a randomized, double-blind, parallel-group, placebo-controlled, multi-center study. This study will compare an Investigational new drug (crofelemer) to placebo for the control of HIV-associated diarrhea. The first stage of the study will determine the optimal dose of study drug based on safety and response to therapy and the second stage will evaluate further the effectiveness of the optimal dose. |
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| Detailed Description | The purpose of this study is to test the efficacy and safety of crofelemer while treating patients with HIV-associated diarrhea. This study has two stages. The first 200 patients into the study will enroll into Stage 1. In Stage 1, three doses of crofelemer will be compared to placebo. In Stage 1, study participants are randomly assigned to 1 of 4 groups:
After Stage 1 is completed, the dose of crofelemer that appears to work best and /or is better tolerated than the others will be selected to be used exclusively in Stage 2. The next 150 subjects that enroll will start in Stage 2 and will be randomly assigned to receive either the selected dose of crofelemer or placebo. In Stage 2, participants will have a 50:50 chance of receiving either crofelemer or placebo. Study Requirements: Each Stage consists of a 10-day screening period, a 31-day study phase (double-blind, placebo-controlled) and a 5-month extension phase (placebo-free, all participants in this stage will receive crofelemer for up to 5 months). Daily phone diary describing diarrhea symptoms will be required throughout the 28 weeks of study participation. Maximum duration of study participation is approximately 28 weeks. Study Phase: Phase III Study Type: Interventional, Supportive care Study Design: Multi-center, Double-blind, Placebo-controlled, Two-stage Adaptive design Primary Outcome Measures: The primary objective is to determine the proportion of HIV-positive subjects experiencing relief of diarrhea with crofelemer compared to placebo during the placebo-controlled treatment phase. Secondary Outcome Measure(s): To evaluate the effects of crofelemer vs. placebo on:
Condition: HIV Associated Diarrhea Intervention: Antidiarrheal Medication; crofelemer |
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| Study Phase | Phase III | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Supportive Care, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||||||
| Primary Outcome Measure † | The primary objective is to determine the proportion of HIV-positive subjects experiencing relief of diarrhea with crofelemer compared to placebo during the placebo-controlled treatment phase. [ Time Frame: 31 days ] | ||||||||
| Secondary Outcome Measure † | To evaluate the effects of crofelemer vs. placebo on: [ Time Frame: 6 months ] Number of bowel movements per day [ Time Frame: 6 months ] Number of watery bowel movements per day [ Time Frame: 6 months ] Symptom frequency [ Time Frame: 6 months ] Symptom severity [ Time Frame: 6 months ] Daily stool consistency score [ Time Frame: 6 months ] Safety and tolerability of [ Time Frame: 6 months ] |
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| Condition † | Diarrhea HIV Infections Gastrointestinal Disease |
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| Intervention † | Drug: crofelemer | ||||||||
| MEDLINE PMIDs | |||||||||
| Links | Study information and patient self screener ![]() |
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 350 | ||||||||
| Start Date † | October 2007 | ||||||||
| Completion Date | March 2009 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | United States, Puerto Rico | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00547898 | ||||||||
| Organization ID | NP303-101 | ||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | Napo Pharmaceuticals, Inc. | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | Napo Pharmaceuticals, Inc. | ||||||||
| Verification Date | November 2008 | ||||||||
| First Received Date † | October 21, 2007 | ||||||||
| Last Updated Date | November 19, 2008 | ||||||||