FDA clears phase 2 trial of drug candidate for ileus, adhesions Ovarian Cancer and Us OVARIAN CANCER and US Ovarian Cancer and Us

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Thursday, October 06, 2016

FDA clears phase 2 trial of drug candidate for ileus, adhesions



pharma press release
 LEADING BIOSCIENCES INC.

Multi-center study of 100-120 patients, evaluating pre- and post-treatment of LB1148 administered orally for major abdominal surgeries. Enrollment expected to begin in August 2016. For ileus, the study will measure the number of hours from surgical closure to resolution of postoperative ileus via various returning gastrointestinal functions. Length of stay will also be measured. For adhesions, study will evaluate whether LB1148 reduces the number of surgical adhesions formed in certain types of abdominal surgeries where a 2nd operation is required.

clincialtrials.gov:

A Study to Evaluate LB1148 for Return of Gastrointestinal Function and Adhesions in Subjects Undergoing Bowel Resection (PROFILE)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2016 by Leading BioSciences, Inc
Sponsor:
Information provided by (Responsible Party):
Leading BioSciences, Inc
ClinicalTrials.gov Identifier:
NCT02836470
First received: July 13, 2016
Last updated: August 29, 2016
Last verified: August 2016
 
Criteria
Inclusion Criteria:
  • Scheduled to undergo an elective (non-emergent) bowel resection with or without a planned stoma via laparotomy or minimally invasive technique. This includes any subject in which a resection of the small intestine, colon, or rectum is performed for any elected indication.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02836470
Contacts
Contact: Thomas M Hallam, PhD 858.704.4900 tom.hallam@leadingbiosciences.com

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