Asimadoline for the Treatment of Post-Operative Ileus

• Status: Terminated
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tioga Pharmaceuticals
• Collaborator: RTI Health Solutions

Criteria

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