Asimadoline for the Treatment of Post-Operative Ileus
- Registration Number
- NCT00443040
- Lead Sponsor
- Tioga Pharmaceuticals
- 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 of bowel function compared to placebo.
- 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 undergoing laparoscopic or hand-assisted laparoscopic colon resections. Subjects meeting entry criteria were randomized in a 1:1:1 ratio to receive either asimadoline 1.0 mg, asimadoline 3.0 mg or a placebo. One hundred and fourteen subjects were planned, and in the event that a subject was converted from a laparoscopic surgery to an open surgery (laparotomy), that subject would be discontinued from the trial and followed for safety only. The protocol allowed subjects converted to open procedures to be replaced. The first dose was administered approximately 90 minutes pre-operatively, and subsequent dosing was b.i.d. for up to 10 post-operative doses. Subjects were dosed with study drug only while in the hospital. After discharge, they were followed for an additional 28 days. Total study duration for each patient was approximately 5 to 6 weeks.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 35
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Asimadoline 1.0 mg Asimadoline Asimadoline 1.0 mg b.i.d. Asimadoline 3.0 mg Asimadoline Asimadoline 3.0 mg b.i.d.
- Primary Outcome Measures
Name Time Method Time to Return of Upper and Lower GI Function Daily for 38 days The time to first bowel movement or the time to tolerating solid food, whichever occurs later.
- Secondary Outcome Measures
Name Time Method Vomiting Score Daily for 38 days Nasogastric Tube Re-insertion Daily for 38 days Proportion of subjects with nasogastric tube re-insertion
Time to Tolerating Solid Food 4 hours of ingesting a meal Time to tolerating solid food (toleration is defined as the absence of nausea or vomiting) within 4 hours of ingesting a meal
Time to Writing of Hospital Discharge Order Daily for 38 days Adverse Events Daily for 38 days Adverse events grouped by body system
Time to First Bowel Movement Daily for 38 days Nausea Score Daily for 38 days Time to First Passage of Flatus Daily for 38 days Pain Score Daily for 38 days Post-operative Analgesic Use Daily for 38 days Laboratory Values Daily for 38 days Changes in laboratory values.
Trial Locations
- Locations (4)
University Hospitals of Cleveland
🇺🇸Cleveland, Ohio, United States
Lahey Clinic
🇺🇸Burlington, Massachusetts, United States
Washington University
🇺🇸St. Louis, Missouri, United States
Marks Colorectal Surgical Associates
🇺🇸Wynnewood, Pennsylvania, United States