4 completed, 2 active not recruiting. 2 Phase 2, 2 Phase 3, 2 Phase 4, 1 Early Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 2 | Active not recruiting 1, Completed 1 |
| Phase 3 | 2 | Active not recruiting 1, Completed 1 |
| Phase 4 | 2 | Completed 2 |
| Early Phase 1 | 1 | Active not recruiting 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Ascending Doses of Crofelemer Powder for Oral Solution in Pediatric Microvillus Inclusion Disease (MVID) Crofelemer Powder for Oral Solution, Placebo Powder for Oral Solution - Microvillus Inclusion Disease, Congenital Disorders | Phase 2 / Phase 3 | Active not recruiting | Napo Pharmaceuticals, Inc. | 6 | 2025-05-01 | 2026-06-09 |
| Open-Label Pilot Study With Crofelemer in Patients With Short Bowel Syndrome Crofelemer Oral Product - Short Bowel Syndrome | Early Phase 1 | Active not recruiting | Jessica Sosio | 6 | 2025-03-03 | 2026-08-19 |
| Prophylaxis of Diarrhea in Adult Cancer Patients Receiving Targeted Cancer Therapy Crofelemer 125 MG [Mytesi], Placebo - Cancer Therapy-Related Diarrhea, Chemotherapy-related Diarrhea | Phase 3 | Completed | Napo Pharmaceuticals, Inc. | 287 | 2020-10-07 | 2024-07-26 |
| Effects of Crofelemer on the Gut Microbiome in Healthy Volunteers and in HIV+ Patients With Non-Infectious Diarrhea Crofelemer delayed-release tablets 125mg - Acquired Immunodeficiency Syndrome, Healthy Volunteers | Phase 4 | Completed | Napo Pharmaceuticals, Inc. | 17 | 2019-10-22 | 2021-10-22 |
| Yield of Diagnostic Tests and Effects of Crofelemer for Chronic Idiopathic Diarrhea In Non-HIV Patients Crofelemer, Diagnostic tests for cause of chronic diarrhea - Chronic Diarrhea of Unknown Origin | Phase 4 | Completed | The University of Texas Health Science Center, Houston | 93 | 2019-04-01 | 2026-02-12 |
| Diarrhea Prevention and Prophylaxis With Crofelemer in HER2 Positive Breast Cancer Patients Crofelemer - Breast Cancer | Phase 2 | Completed | Sandra Swain | 53 | 2017-01-31 | 2022-10-24 |
Diarrhea (2) · Acquired Immunodeficiency Syndrome (1) · Breast Neoplasms (1) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (1) · Disease (1) · Microvillus inclusion disease (1) · Rare Diseases (1) · Short Bowel Syndrome (1)
crofelemer (3) · Diagnostic Tests, Routine (1) · Solutions (1)
United States (6) · Argentina (1) · Georgia (1) · Italy (1) · Serbia (1) · Taiwan (1) · United Arab Emirates (1)
Pravin Chaturvedi, PhD (2) · Brooks Cash, MD (1) · David Smith, MD (1) · Lindsey Russell (1) · Lissette Jimenez, MD, MPH (1) · Pablo Okhuysen, MD (1)