Status:
TERMINATED
Asimadoline for the Treatment of Post-Operative Ileus
Lead Sponsor:
Tioga Pharmaceuticals
Collaborating Sponsors:
RTI Health Solutions
Conditions:
Post-Operative Ileus
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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 ...
Detailed Description
This randomized, double-blind, placebo-controlled study was designed to evaluate the efficacy and tolerability of two dose levels of asimadoline on the duration of post-operative ileus in subjects und...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00443040
Start Date
January 1 2007
End Date
February 1 2008
Last Update
January 6 2012
Active Locations (4)
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1
Lahey Clinic
Burlington, Massachusetts, United States, 01805
2
Washington University
St Louis, Missouri, United States, 63110
3
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106-5047
4
Marks Colorectal Surgical Associates
Wynnewood, Pennsylvania, United States, 19096