Asimadoline for the Treatment of Post-Operative Ileus

PHASE2TerminatedINTERVENTIONAL
Enrollment

35

Participants

Timeline

Start Date

January 31, 2007

Primary Completion Date

February 29, 2008

Study Completion Date

February 29, 2008

Conditions
Post-Operative Ileus
Interventions
DRUG

Asimadoline

Asimadoline was provided in coated tablets of 1.0 mg strength. Subjects were given 3 tablets of study drug 90 minutes prior to their operation and then 3 tablets b.i.d. for up to 10 post-operative doses. Subjects randomized to receive 3.0 mg of asimadoline received three 1.0 mg asimadoline tablets at each scheduled dose, while those randomized to receive 1.0 mg of asimadoline received two placebo tablets and one 1.0 mg asimadoline tablet at each scheduled dose.

DRUG

Placebo

Placebo was provided in coated tablets identical in appearance to asimadoline tablets. Subjects were given 3 tablets of placebo 90 minutes prior to their operation and then 3 placebo tablets b.i.d. for up to 10 post-operative doses.

Trial Locations (4)

19096

Marks Colorectal Surgical Associates, Wynnewood

63110

Washington University, St Louis

01805

Lahey Clinic, Burlington

44106-5047

University Hospitals of Cleveland, Cleveland

Sponsors
All Listed Sponsors
collaborator

RTI Health Solutions

OTHER

lead

Tioga Pharmaceuticals

INDUSTRY

NCT00443040 - Asimadoline for the Treatment of Post-Operative Ileus | Biotech Hunter | Biotech Hunter