Clinical trial NCT00443040: Asimadoline for the Treatment of Post-Operative Ileus
Official title: A Randomized, Double-Blind, Placebo-Controlled Study Evaluating Asimadoline on the Duration of POI in Subjects Undergoing Laparoscopic/Hand-Assisted Lap Segmental Colonic Resection Secondary to Colon Cancer, Polypectomy or Diverticulitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Post-Operative Ileus
Lead sponsor: Tioga Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: RTI Health Solutions
First posted: 2007-03-05
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Time to Return of Upper and Lower GI Function
timeFrame: Daily for 38 days
Secondary outcomes:
measure: Time to Tolerating Solid Food
timeFrame: 4 hours of ingesting a meal
measure: Time to First Passage of Flatus
timeFrame: Daily for 38 days
measure: Time to First Bowel Movement
timeFrame: Daily for 38 days
measure: Time to Writing of Hospital Discharge Order
timeFrame: Daily for 38 days
measure: Nausea Score
timeFrame: Daily for 38 days
measure: Vomiting Score
timeFrame: Daily for 38 days
measure: Pain Score
timeFrame: Daily for 38 days
measure: Nasogastric Tube Re-insertion
timeFrame: Daily for 38 days
measure: Post-operative Analgesic Use
timeFrame: Daily for 38 days
measure: Adverse Events
timeFrame: Daily for 38 days
measure: Laboratory Values
timeFrame: Daily for 38 days
Other outcomes:
Locations:
city: Burlington
country: United States
facility: Lahey Clinic
state: Massachusetts
city: St. Louis
country: United States
facility: Washington University
state: Missouri
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
city: Wynnewood
country: United States
facility: Marks Colorectal Surgical Associates
state: Pennsylvania
Study officials:
affiliation: CMO
name: Allen Mangel, MD, PhD
role: STUDY_CHAIR
References: