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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 is a Phase 3 study that has completed, run by Napo Pharmaceuticals. The registered enrollment target is 287 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04538625
The ClinicalTrials.gov registry entry for NCT04538625 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 287 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Napo Pharmaceuticals, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04538625 reports 0 study locations.
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.
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