TerminatedPhase 2

Asimadoline for the Treatment of Post-Operative Ileus

Stopped: poor enrollment (31 of a planned 114 subjects were randomized and evaluable)

United States35 participantsStarted 2007-01

Plain-language summary

The purpose of this study is to evaluate the safety and efficacy of asimadoline in patients who have undergone a laparoscopic segmental colectomy and determine whether it reduces the time to recovery of bowel function compared to placebo.

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Males and females aged 18-80 * Must be scheduled to undergo a laparoscopic/hand-assisted laparoscopic segmental colectomy * Must sign an ICF * Females of childbearing potential must have a negative pregnancy test at screening Exclusion Criteria: * Subjects with evidence of a biochemical or structural abnormality of the GI tract or other co-morbid illness that may impact the ability to interpret the safety and efficacy data * Pregnant or breastfeeding females * Use of investigational drugs in previous 30 days * Refusal to discontinue prohibited concomitant medications * Chronic use of prescription narcotics over the previous 6 months

What they're measuring

Time to Return of Upper and Lower GI Function

Timeframe: Daily for 38 days

Trial details

NCT IDNCT00443040

SponsorTioga Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2008-02

Results submitted2011-10-14

View on ClinicalTrials.gov More Post-Operative Ileus trials