11 completed, 1 terminated. 4 Phase 2, 4 Phase 3, 2 Not applicable, 2 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 4 | Completed 4 |
| Phase 3 | 4 | Completed 4 |
| Not applicable | 2 | Completed 2 |
| Phase 4 | 2 | Completed 1, Terminated 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 |
|---|---|---|---|---|---|---|
| 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 |
| Crofelemer for Functional Diarrhea Crofelemer, Placebo - Diarrhea | Phase 4 | Terminated | Beth Israel Deaconess Medical Center | 17 | 2020-08-20 | 2026-03-10 |
| 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 |
| Incidence and Severity of Diarrhea in Patients With HER2 Positive Breast Cancer Treated With Trastuzumab and Neratinib Neratinib, Trastuzumab, Loperamide - HER2-positive Breast Cancer, Breast Adenocarcinoma | Phase 2 | Completed | University of California, San Francisco | 11 | 2018-10-09 | 2025-06-26 |
| 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 |
| Safety and Tolerability of Crofelemer for HIV-Associated Diarrhea Crofelemer - HIV Enteropathy, Diarrhea With HIV | Phase 3 | Completed | Bausch Health Americas, Inc. | 250 | 2011-06-07 | 2020-08-31 |
| Safety and Effectiveness of 3 Doses of Crofelemer Compared to Placebo in the Treatment of HIV Associated Diarrhea Crofelemer 125 mg, Crofelemer 250 mg, Crofelemer 500 mg - HIV Associated Diarrhea | Phase 3 | Completed | Bausch Health Americas, Inc. | 374 | 2007-10-01 | 2020-09-03 |
| Diarrhea Predominant Irritable Bowel Syndrome in Females crofelemer - Irritable Bowel Syndrome | Phase 2 | Completed | Bausch Health Americas, Inc. | 240 | 2006-10-01 | 2019-11-25 |
| A Study of Crofelemer to Treat Diarrhea Irritable Bowel Syndrome crofelemer - Irritable Bowel Syndrome, Colonic Diseases | Phase 2 | Completed | Bausch Health Americas, Inc. | 245 | 2004-12-01 | 2019-11-25 |
| A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Orally Administered SP-303 for the Treatment of Diarrhea in Acquired Immunodeficiency Syndrome (AIDS) Patients Crofelemer - Diarrhea, HIV Infections | Phase 3 | Completed | Shaman Pharmaceuticals | 300 | 2005-06-24 | |
| Double-Blind Placebo-Controlled Study Comparing the Combination of 15% SP-303 Gel With Acyclovir Versus Acyclovir Alone for the Treatment of Recurrent Herpes Simplex Virus (HSV) Infections in Subjects With Acquired Immunodeficiency Syndrome (AIDS) Crofelemer, Acyclovir - Herpes Simplex, HIV Infections | Not applicable | Completed | Shaman Pharmaceuticals | 400 | 2005-06-24 | |
| SP-303T Applied to the Skin of Patients With Herpes Simplex Virus (HSV) Infection and AIDS Who Have Not Had Success With Acyclovir Crofelemer - Herpes Simplex, HIV Infections | Not applicable | Completed | Shaman Pharmaceuticals | 2005-06-24 |
Diarrhea (6) · Acquired Immunodeficiency Syndrome (4) · HIV Infections (3) · Breast Neoplasms (2) · Herpes Simplex (2) · Irritable Bowel Syndrome (2) · AIDS-Related Opportunistic Infections (1) · Abdominal Pain (1) · Colonic Diseases (1) · Disease (1) · Gastrointestinal Diseases (1) · HIV Enteropathy (1) · HIV Seropositivity (1)
Bausch Health Americas, Inc. (4) · Shaman Pharmaceuticals (3) · Beth Israel Deaconess Medical Center (1) · Napo Pharmaceuticals, Inc. (1) · Sandra Swain (1) · The University of Texas Health Science Center, Houston (1) · University of California, San Francisco (1)
United States (12) · Puerto Rico (3) · Argentina (1) · Georgia (1) · Serbia (1) · Taiwan (1)
Anthony Lembo, MD (1) · Brooks Cash, MD (1) · Jo Chien, MD (1) · Pablo Okhuysen, MD (1) · Pravin Chaturvedi, PhD (1)