Asimadoline for the Treatment of Post-Operative Ileus

Post-Operative Ileus Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00443040
• Other study ID #: ASMP2004
• Status: Terminated
• Phase: Phase 2
• First received: February 27, 2007
• Last updated: November 30, 2011
• Start date: January 2007
• Est. completion date: February 2008

Study information

• Verified date: November 2011
• Source: Tioga Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 35
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Post-Operative Ileus

Intervention

Drug:
• Asimadoline
Asimadoline was provided in coated tablets of 1.0 mg strength. Subjects were given 3 tablets of study drug 90 minutes prior to their operation and then 3 tablets b.i.d. for up to 10 post-operative doses. Subjects randomized to receive 3.0 mg of asimadoline received three 1.0 mg asimadoline tablets at each scheduled dose, while those randomized to receive 1.0 mg of asimadoline received two placebo tablets and one 1.0 mg asimadoline tablet at each scheduled dose.
• Placebo
Placebo was provided in coated tablets identical in appearance to asimadoline tablets. Subjects were given 3 tablets of placebo 90 minutes prior to their operation and then 3 placebo tablets b.i.d. for up to 10 post-operative doses.

Locations

Country	Name	City	State
United States	Lahey Clinic	Burlington	Massachusetts
United States	University Hospitals of Cleveland	Cleveland	Ohio
United States	Washington University	St. Louis	Missouri
United States	Marks Colorectal Surgical Associates	Wynnewood	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Tioga Pharmaceuticals	RTI Health Solutions

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Return of Upper and Lower GI Function	The time to first bowel movement or the time to tolerating solid food, whichever occurs later.	Daily for 38 days	No
Secondary	Time to Tolerating Solid Food	Time to tolerating solid food (toleration is defined as the absence of nausea or vomiting) within 4 hours of ingesting a meal	4 hours of ingesting a meal	No
Secondary	Time to First Passage of Flatus		Daily for 38 days	No
Secondary	Time to First Bowel Movement		Daily for 38 days	No
Secondary	Time to Writing of Hospital Discharge Order		Daily for 38 days	No
Secondary	Nausea Score		Daily for 38 days	No
Secondary	Vomiting Score		Daily for 38 days	No
Secondary	Pain Score		Daily for 38 days	No
Secondary	Nasogastric Tube Re-insertion	Proportion of subjects with nasogastric tube re-insertion	Daily for 38 days	No
Secondary	Post-operative Analgesic Use		Daily for 38 days	No
Secondary	Adverse Events	Adverse events grouped by body system	Daily for 38 days	Yes
Secondary	Laboratory Values	Changes in laboratory values.	Daily for 38 days	Yes