Asimadoline for the Treatment of Post-Operative Ileus

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Post-Operative Ileus

In brief

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.

Key facts

Study ID

NCT00443040

Run by

Tioga Pharmaceuticals

People needed

35

Starts

2007-01-01

Expected to finish

2008-02-01

Last updated by the study team

2012-01-06

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Lahey Clinic — Burlington, Massachusetts, United States
• Washington University — St Louis, Missouri, United States
• University Hospitals of Cleveland — Cleveland, Ohio, United States
• Marks Colorectal Surgical Associates — Wynnewood, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.