Crofelemer
Sponsors
Napo Therapeutics S.p.A., Shaman Pharmaceuticals, Bausch Health Americas, Inc., Sandra Swain, University of California, San Francisco
Conditions
Breast AdenocarcinomaBreast CancerChronic Diarrhea of Unknown OriginColonic DiseasesDiarrheaDiarrhea With HIVGastrointestinal DiseaseHER2-positive Breast Cancer
Phase 2
A Study of Crofelemer to Treat Diarrhea Irritable Bowel Syndrome
CompletedNCT00101725
Start: 2004-12-31End: 2005-11-30Updated: 2019-11-25
Diarrhea Predominant Irritable Bowel Syndrome in Females
CompletedNCT00461526
Start: 2006-10-31End: 2007-12-31Updated: 2019-11-25
Diarrhea Prevention and Prophylaxis With Crofelemer in HER2 Positive Breast Cancer Patients
CompletedNCT02910219
Start: 2017-01-31End: 2020-11-23Updated: 2022-10-24
Incidence and Severity of Diarrhea in Patients With HER2 Positive Breast Cancer Treated With Trastuzumab and Neratinib
CompletedNCT03094052
Start: 2018-10-09End: 2022-10-31Updated: 2025-06-26
A Phase 2, Placebo-Controlled, Randomized, Double-Blind Study of 2 Doses of Crofelemer for the Treatment of adult patients with Short Bowel Syndrome and Intestinal Failure (SBS-IF) without colon in continuity (CIC)
RecruitingCTIS2024-511994-31-00
Start: 2025-03-10Target: 22Updated: 2025-12-23
Phase 3
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
CompletedNCT00002408
Target: 300Updated: 2005-06-24
Safety and Tolerability of Crofelemer for HIV-Associated Diarrhea
CompletedNCT01374490
Start: 2011-06-07End: 2012-10-31Updated: 2020-08-31
Phase 4
Unknown Phase
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)
CompletedNCT00002186
Target: 400Updated: 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
CompletedNCT00002310
Updated: 2005-06-24