35
Participants
Start Date
January 31, 2007
Primary Completion Date
February 29, 2008
Study Completion Date
February 29, 2008
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.
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.
Marks Colorectal Surgical Associates, Wynnewood
Washington University, St Louis
Lahey Clinic, Burlington
University Hospitals of Cleveland, Cleveland
Lead Sponsor
RTI Health Solutions
OTHER
Tioga Pharmaceuticals
INDUSTRY