Prophylaxis of Diarrhea in Adult Cancer Patients Receiving Targeted Cancer Therapy
Public ClinicalTrials.gov record NCT04538625. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3 Multicenter, Randomized, Double-blind Placebo-controlled Trial Evaluating Crofelemer for the Prophylaxis of Diarrhea in Adult Patients With Solid Tumors Receiving Targeted-cancer Therapies With or Without Standard Chemotherapy
Study identification
- NCT ID
- NCT04538625
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Napo Pharmaceuticals, Inc.
- Industry
- Enrollment
- 287 participants
Conditions and interventions
Conditions
Interventions
- Crofelemer 125 MG [Mytesi] Drug
- Placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 6, 2020
- Primary completion
- Aug 6, 2023
- Completion
- Oct 29, 2023
- Last update posted
- Jul 25, 2024
2020 – 2023
United States locations
- U.S. sites
- 27
- U.S. states
- 14
- U.S. cities
- 27
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Oncology Associates PC - HAL | Prescott | Arizona | 86314 | — |
| Pacific Cancer Medical Center Inc | Anaheim | California | 92801 | — |
| The Oncology Institute of Hope and Innovation | Corona | California | 92882 | — |
| The Oncology Institute of Hope and Innovation | Glendale | California | 91204 | — |
| PIH Health Whittier Hospital | Whittier | California | 90602 | — |
| SCL Health Research Institute | Lafayette | Colorado | 80218 | — |
| GenesisCare USA | Aventura | Florida | 33180 | — |
| Cancer Care Centers of Brevard, Inc. | Palm Bay | Florida | 32909 | — |
| BRCR Global | Plantation | Florida | 33322 | — |
| Advanced Research Institute | St. Petersburg | Florida | 33710 | — |
| American Oncology Partners of Maryland | Bethesda | Maryland | 20817 | — |
| Minnesota Oncology Hematology, P.A. | Minneapolis | Minnesota | 55404 | — |
| Nebraska Methodist Hospital | Omaha | Nebraska | 68114 | — |
| North Shore Hematology Oncology Associates dba New York Cancer and Blood Specialists | Port Jefferson Station | New York | 11776 | — |
| Jacobi Medical Center | The Bronx | New York | 10461 | — |
| Gabrail Cancer Research | Canton | Ohio | 44718 | — |
| Oregon Health & Science University (OHSU) Knight Cancer Institute | Portland | Oregon | 97239 | — |
| The West Clinic Research | Germantown | Tennessee | 38138 | — |
| Texas Oncology - Denison | Denison | Texas | 75020 | — |
| Texas Oncology, P.A. - Flower Mound | Flower Mound | Texas | 75028 | — |
| MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| Texas Oncology - New Braunfels | New Braunfels | Texas | 78130 | — |
| Texas Oncology - Plano East | Plano | Texas | 75075-7787 | — |
| Texas Oncology - Gulf Coast | Webster | Texas | 77598 | — |
| Inova Schar Cancer Institute | Fairfax | Virginia | 22031 | — |
| Shenandoah Oncology Associates | Winchester | Virginia | 22601 | — |
| MultiCare Institute for Research and Innovation | Tacoma | Washington | 98405 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 25 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04538625, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 25, 2024 · Synced May 12, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04538625 live on ClinicalTrials.gov.