Asimadoline for the Treatment of Post-Operative Ileus

Tioga Pharmaceuticals

Status and phase: Terminated; Phase 2

Conditions: Post-Operative Ileus

Treatments: Drug: Placebo; Drug: Asimadoline

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00443040

ASMP2004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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35 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Asimadoline 1.0 mg

Active Comparator group

Description:

Asimadoline 1.0 mg b.i.d.

Treatment:

Drug: Asimadoline

Asimadoline 3.0 mg

Active Comparator group

Description:

Asimadoline 3.0 mg b.i.d.

Treatment:

Drug: Asimadoline