Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00443040
Status:
TERMINATED
Last Update Posted:
2012-01-06
First Post:
2007-02-27
Brief Title:
Asimadoline for the Treatment of Post-Operative Ileus
Sponsor:
Tioga Pharmaceuticals
Organization:
Tioga Pharmaceuticals
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Study Evaluating Asimadoline on the Duration of POI in Subjects Undergoing LaparoscopicHand-Assisted Lap Segmental Colonic Resection Secondary to Colon Cancer Polypectomy or Diverticulitis
Status:
TERMINATED
Status Verified Date:
2011-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
poor enrollment 31 of a planned 114 subjects were randomized and evaluable
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 111 ratio to receive either asimadoline 10 mg asimadoline 30 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 bid 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None