A Phase III Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Investigational Product MP-101 in Subjects With Short Bowel Syndrome Who Have Had an Inadequate Response to Anti-Diarrheals

PHASE3WithdrawnINTERVENTIONAL
0
Timeline

Start Date

December 31, 2014

Primary Completion Date

December 31, 2017

Conditions
Short Bowel SyndromeShort Gut SyndromeSBSShort BowelShort Gut
Interventions
DRUG

Opium Tincture USP Deodorized

Treatment A - 0.6 mL, MP-101 (10 mg/mL, Opium Tincture (OT)), USP (Deodorized) QID oral drops, followed by Treatment B - 0.6 mL, MP-101, 1/12 dilution, (0.833 mg/mL, OT), USP (Deodorized) QID oral drops, followed by Treatment C - 0.6 mL, MP-101 (10 mg/mL Opium Tincture with reduced uncharacterized material) QID oral drops

DRUG

Opium Tincture USP Deodorized

Treatment B - 0.6 mL, MP-101, 1/12 dilution, (0.833 mg/mL, OT), USP (Deodorized) QID oral drops, followed by Treatment A - 0.6 mL, MP-101 (10 mg/mL, Opium Tincture (OT)), USP (Deodorized) QID oral drops, followed by Treatment C - 0.6 mL, MP-101 (10 mg/mL Opium Tincture with reduced uncharacterized material) QID oral drops

Trial Locations (5)

44195

Cleveland Clinic, Cleveland

45801

Regional Infectious Diseases Infusion Center, Lima

46202

Indiana University, Indianapolis

60611

Northwestern University Feinberg School of Medicine, Chicago

37212-1150

Vanderbilt Center for Human Nutrition, Nashville

Sponsors
All Listed Sponsors
lead

Marathon Pharmaceuticals, LLC

INDUSTRY