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Filters: Intervention: crofelemer Clear all

Conditions: Diarrhea
Interventions: Crofelemer, Placebo; Drug
Lead sponsor: Beth Israel Deaconess Medical Center; Other
Eligibility: 18 Years to 65 Years
Enrollment: 17 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2020 – 2022
U.S. locations: 1
States / cities: Boston, Massachusetts

Conditions: Irritable Bowel Syndrome
Interventions: crofelemer; Drug
Lead sponsor: Bausch Health Americas, Inc.; Industry
Eligibility: 18 Years and older · Female only
Enrollment: 240 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2006 – 2007
U.S. locations: 43
States / cities: Huntsville, Alabama • Chandler, Arizona • Tucson, Arizona + 36 more

Conditions: Herpes Simplex, HIV Infections
Interventions: Crofelemer, Acyclovir; Drug
Lead sponsor: Shaman Pharmaceuticals; Industry
Eligibility: 18 Years and older
Enrollment: 400 participants
Healthy volunteers: Healthy volunteers not accepted
U.S. locations: 32
States / cities: Birmingham, Alabama • Scottsdale, Arizona • Tucson, Arizona + 23 more

Conditions: HIV Associated Diarrhea
Interventions: Crofelemer 125 mg, Crofelemer 250 mg, Crofelemer 500 mg, Placebo; Drug
Lead sponsor: Bausch Health Americas, Inc.; Industry
Eligibility: 18 Years and older
Enrollment: 374 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2007 – 2011
U.S. locations: 79
States / cities: Huntsville, Alabama • Phoenix, Arizona • Little Rock, Arkansas + 53 more

Conditions: Cancer Therapy-Related Diarrhea, Chemotherapy-related Diarrhea, Adult Solid Tumor, Prophylaxis of Diarrhea, Symptomatic Relief of Diarrhea, Targeted Therapy-related Diarrhea
Interventions: Crofelemer 125 MG [Mytesi], Placebo; Drug
Lead sponsor: Napo Pharmaceuticals, Inc.; Industry
Eligibility: 18 Years and older
Enrollment: 287 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2020 – 2023
U.S. locations: 27
States / cities: Prescott, Arizona • Anaheim, California • Corona, California + 24 more

Conditions: HIV Enteropathy, Diarrhea With HIV
Interventions: Crofelemer; Drug
Lead sponsor: Bausch Health Americas, Inc.; Industry
Eligibility: 18 Years and older
Enrollment: 250 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2011 – 2012
U.S. locations: 21
States / cities: Phoenix, Arizona • Little Rock, Arkansas • Bakersfield, California + 16 more

Conditions: Diarrhea, HIV Infections
Interventions: Crofelemer; Drug
Lead sponsor: Shaman Pharmaceuticals; Industry
Eligibility: 18 Years and older
Enrollment: 300 participants
Healthy volunteers: Healthy volunteers not accepted
U.S. locations: 34
States / cities: Scottsdale, Arizona • Los Angeles, California • Palo Alto, California + 25 more

Conditions: Breast Cancer
Interventions: Crofelemer; Drug
Lead sponsor: Sandra Swain; Other
Eligibility: 18 Years and older
Enrollment: 53 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2017 – 2020
U.S. locations: 4
States / cities: Washington D.C., District of Columbia • Baltimore, Maryland • Hackensack, New Jersey

Conditions: Herpes Simplex, HIV Infections
Interventions: Crofelemer; Drug
Lead sponsor: Shaman Pharmaceuticals; Industry
Eligibility: 18 Years and older
Healthy volunteers: Healthy volunteers not accepted
U.S. locations: 4
States / cities: San Francisco, California • Fort Lauderdale, Florida • New York, New York + 1 more

Conditions: Chronic Diarrhea of Unknown Origin
Interventions: Crofelemer, Diagnostic tests for cause of chronic diarrhea; Drug · Diagnostic Test
Lead sponsor: The University of Texas Health Science Center, Houston; Other
Eligibility: 18 Years to 75 Years
Enrollment: 93 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2019 – 2025
U.S. locations: 1
States / cities: Houston, Texas

Conditions: Acquired Immunodeficiency Syndrome, Healthy Volunteers, HIV/AIDS, HIV Diarrhea, Human Immunodeficiency Virus
Interventions: Crofelemer delayed-release tablets 125mg; Drug
Lead sponsor: Napo Pharmaceuticals, Inc.; Industry
Eligibility: 18 Years and older
Enrollment: 17 participants
Healthy volunteers: Accepts healthy volunteers
Timeline: 2019 – 2021
U.S. locations: 3
States / cities: Tustin, California • Stratford, Connecticut • Springfield, Massachusetts

Conditions: Irritable Bowel Syndrome, Colonic Diseases, Diarrhea, Gastrointestinal Disease
Interventions: crofelemer; Drug
Lead sponsor: Bausch Health Americas, Inc.; Industry
Eligibility: 18 Years and older
Enrollment: 245 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2004 – 2005
U.S. locations: 29
States / cities: Huntsville, Alabama • Chandler, Arizona • North Little Rock, Arkansas + 24 more

Conditions: Short Bowel Syndrome
Interventions: Crofelemer Oral Product; Drug
Lead sponsor: Jessica Sosio; Other
Eligibility: 18 Years and older
Enrollment: 6 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2025 – 2026
U.S. locations: 1
States / cities: Cleveland, Ohio

Conditions: HER2-positive Breast Cancer, Breast Adenocarcinoma, Stage II Breast Cancer AJCC v6 and v7, Stage IIA Breast Cancer AJCC v6 and v7, Stage IIB Breast Cancer AJCC v6 and v7, Stage III Breast Cancer AJCC v7, Stage IIIA Breast Cancer AJCC v7, Stage IIIB Breast Cancer AJCC v7, Stage IIIC Breast Cancer AJCC v7
Interventions: Neratinib, Trastuzumab, Loperamide, Crofelemer, Diphenoxylate/Atropine; Drug · Biological
Lead sponsor: University of California, San Francisco; Other
Eligibility: 18 Years and older
Enrollment: 11 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2018 – 2022
U.S. locations: 1
States / cities: San Francisco, California

Conditions: Microvillus Inclusion Disease, Congenital Disorders, Rare Diseases
Interventions: Crofelemer Powder for Oral Solution, Placebo Powder for Oral Solution; Drug
Lead sponsor: Napo Pharmaceuticals, Inc.; Industry
Eligibility: Up to 17 Years
Enrollment: 6 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2025 – 2026
U.S. locations: 1
States / cities: Boston, Massachusetts

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Crofelemer for Functional Diarrhea

Diarrhea Predominant Irritable Bowel Syndrome in Females

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)

Safety and Effectiveness of 3 Doses of Crofelemer Compared to Placebo in the Treatment of HIV Associated Diarrhea

Prophylaxis of Diarrhea in Adult Cancer Patients Receiving Targeted Cancer Therapy

Safety and Tolerability of Crofelemer for HIV-Associated Diarrhea

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

Diarrhea Prevention and Prophylaxis With Crofelemer in HER2 Positive Breast Cancer Patients

SP-303T Applied to the Skin of Patients With Herpes Simplex Virus (HSV) Infection and AIDS Who Have Not Had Success With Acyclovir

Yield of Diagnostic Tests and Effects of Crofelemer for Chronic Idiopathic Diarrhea In Non-HIV Patients

Effects of Crofelemer on the Gut Microbiome in Healthy Volunteers and in HIV+ Patients With Non-Infectious Diarrhea

A Study of Crofelemer to Treat Diarrhea Irritable Bowel Syndrome

Open-Label Pilot Study With Crofelemer in Patients With Short Bowel Syndrome

Incidence and Severity of Diarrhea in Patients With HER2 Positive Breast Cancer Treated With Trastuzumab and Neratinib

Ascending Doses of Crofelemer Powder for Oral Solution in Pediatric Microvillus Inclusion Disease (MVID)