CLINICAL TRIALS PROFILE FOR CROFELEMER

All Clinical Trials for CROFELEMER

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002186 ↗	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)	Completed	Shaman Pharmaceuticals	N/A	1969-12-31	To evaluate the safety of topically applied SP-303 gel and to compare the efficacy of SP-303 gel in combination with acyclovir, relative to acyclovir alone, for the treatment of recurrent Herpes Simplex Virus (HSV) 1 and 2 infections, affecting the genital, perianal and neighboring areas, in patients with AIDS.
NCT00002310 ↗	SP-303T Applied to the Skin of Patients With Herpes Simplex Virus (HSV) Infection and AIDS Who Have Not Had Success With Acyclovir	Completed	Shaman Pharmaceuticals	N/A	1969-12-31	To evaluate the safety and tolerance of topically applied SP-303T in AIDS patients. To observe the effect of this drug on herpes simplex virus lesions in patients who have failed to heal in response to oral or intravenous acyclovir therapy. The lack of alternative treatments for herpes simplex virus infection in patients with AIDS and the development of resistance to acyclovir for patients requiring repeated treatment presents a therapeutic dilemma for physicians. SP-303T has good in vitro activity against resistant strains and offers a convenient and inexpensive means of drug administration in comparison to the use of intravenous medication.
NCT00002408 ↗	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	Completed	Shaman Pharmaceuticals	Phase 3	1969-12-31	To evaluate the efficacy, safety, and durability of response of SP-303 in decreasing stool weight in AIDS patients with diarrhea over 6 days of treatment.
NCT00101725 ↗	A Study of Crofelemer to Treat Diarrhea Irritable Bowel Syndrome	Completed	Bausch Health Americas, Inc.	Phase 2	2004-12-01	This study is designed to evaluate the safety and effectiveness of an investigational drug, TRN-002 (crofelemer) to relieve the symptoms of diarrhea-predominant irritable bowel syndrome (IBS).
NCT00101725 ↗	A Study of Crofelemer to Treat Diarrhea Irritable Bowel Syndrome	Completed	Valeant Pharmaceuticals International, Inc.	Phase 2	2004-12-01	This study is designed to evaluate the safety and effectiveness of an investigational drug, TRN-002 (crofelemer) to relieve the symptoms of diarrhea-predominant irritable bowel syndrome (IBS).
NCT00461526 ↗	Diarrhea Predominant Irritable Bowel Syndrome in Females	Completed	Bausch Health Americas, Inc.	Phase 2	2006-10-01	Clinical Trial with TRN-002 in Women with Irritable Bowel Syndrome (IBS) The purpose of this study is to investigate the safety and effectiveness of a new investigational drug in women for the treatment of diarrhea-predominant irritable bowel syndrome. The investigational drug is a natural product taken from a plant that grows in South America. The study medication will be administered orally twice a day. Subjects will be not able to remain on certain standard IBS medications (anti-diarrheals) while participating in the study. The total duration of the study is 18 weeks. The study requires five study visits that include physical exams, ECG, blood draws, laboratory studies, and a colon procedure (such as a colonoscopy or flexible sigmoidoscopy if an appropriate procedure has not been performed in the last 5 years.) Participants will be asked to make entries into a touch-tone telephone diary on a daily basis. Participants must meet all of the following criteria: - Females at least 18 years of age - Diagnosis of diarrhea predominant Irritable Bowel Syndrome - Willingness to make daily calls on a touch-tone telephone - Willingness to have an endoscopic and/or radiologic bowel evaluation, if you have not received one in the past 5 years. - Willingness to take an approved method of birth control (if required) Participants CANNOT meet any of the following criteria: - Serious medical or surgical conditions - Colon Cancer, Crohns Disease or Ulcerative Colitis - Pregnant or breast feeding

Clinical Trial Conditions for CROFELEMER

Condition Name

Condition Name for CROFELEMER
Intervention	Trials
HIV Infections	3
Diarrhea	3
Herpes Simplex	2
Irritable Bowel Syndrome	2

Condition MeSH

Condition MeSH for CROFELEMER
Intervention	Trials
Diarrhea	11
Immunologic Deficiency Syndromes	4
HIV Infections	4
Acquired Immunodeficiency Syndrome	4

Clinical Trial Locations for CROFELEMER

Trials by Country

Trials by Country for CROFELEMER
Location	Trials
United States	129
Puerto Rico	3

Trials by US State

Trials by US State for CROFELEMER
Location	Trials
California	10
Texas	8
New York	8
Florida	8
Washington	6

Clinical Trial Progress for CROFELEMER

Clinical Trial Phase

Clinical Trial Phase for CROFELEMER
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	4
Phase 2	4

Clinical Trial Status

Clinical Trial Status for CROFELEMER
Clinical Trial Phase	Trials
Completed	9
Recruiting	4

Clinical Trial Sponsors for CROFELEMER

Sponsor Name

Sponsor Name for CROFELEMER
Sponsor	Trials
Napo Pharmaceuticals, Inc.	5
Bausch Health Americas, Inc.	4
Valeant Pharmaceuticals International, Inc.	4

Sponsor Type

Sponsor Type for CROFELEMER
Sponsor	Trials
Industry	18
Other	7