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NCT04538625 · ClinicalTrials.gov registry record · Phase 3
Prophylaxis of Diarrhea in Adult Cancer Patients Receiving Targeted Cancer Therapy
A Phase 3 study, sponsored by Napo Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 287
- Enrollment target
NCT04538625: Completed Phase 3 study, sponsored by Napo Pharmaceuticals.
NCT04538625 is a Phase 3 study that has completed, run by Napo Pharmaceuticals. The registered enrollment target is 287 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04538625, a Phase 3 study, has completed, sponsored by Napo Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 287 participants
- Enrollment target
Study Summary
A 24-week, (two 12-week stages), randomized, placebo-controlled, double-blind study to evaluate the safety and efficacy of crofelemer in providing prophylaxis of diarrhea in adult patients with solid tumors treated with targeted cancer therapy-containing treatment regimens. Diarrhea grading will be done according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. Patients will be randomized 1:1 to placebo or crofelemer and will be stratified by the type of targeted cancer therapy and the tumor type. Placebo and/or crofelemer will be dispensed at Visit 1/Day 1 with the concurrent start of the targeted cancer therapy regimen. The initial Stage I double-blind placebo-controlled primary treatment phase will occur over a 12-week period to accommodate approximately 3 cycle chemotherapy cancer treatment dosing-cycles. The Primary and Secondary Endpoints will be analyzed after the last patient last visit (LPLV) of Stage I. After completing the Stage I double-blind, placebo-controlled primary treatment phase, the subjects will have the option to remain on their assigned treatment arm and reconsented to enter into the Stage II extension phase. Reconsent will be required to enter into Stage II. For subjects who do not reconsent, visit 5 will be the last study visit.
Primary Outcome
The frequency of diarrhea as measured by the average number of loose/watery stools per week will be evaluated as a continuous endpoint.
Interventions
- DRUG Placebo
- DRUG Crofelemer 125 MG [Mytesi]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 287 participants |
| Start Date | 2020-10-07 |
| Est. Completion | 2023-10-30 |
| Phase | Phase 3 |
What the finished NCT04538625 record still lists
NCT04538625 is an interventional study that assigns participants to a tested intervention. The registered 287 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04538625 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04538625 about?
NCT04538625 is a clinical study titled "Prophylaxis of Diarrhea in Adult Cancer Patients Receiving Targeted Cancer Therapy". A 24-week, (two 12-week stages), randomized, placebo-controlled, double-blind study to evaluate the safety and efficacy of crofelemer in providing prophylaxis of diarrhea in adult patients with solid tumors treated with targeted cancer therapy-containing treatment regimens. Diarrhea grading will be ...
What is the current status of trial NCT04538625?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 287 participants. The study started on 2020-10-07. Estimated completion is 2023-10-30.
What interventions are being tested in trial NCT04538625?
The interventions under investigation include: Placebo (DRUG), Crofelemer 125 MG [Mytesi] (DRUG).
Who is sponsoring clinical trial NCT04538625?
This trial is sponsored by Napo Pharmaceuticals, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04538625's enrollment target sits among peer trials
287 1182nd of 2000 higher than 819 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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