Clinical Trial: The Diabetic and Idiopathic Gastroparesis Efficacy, Safety, and Tolerability (DIGEST) Study
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Phase 2 Study to Assess the Efficacy, Safety, and Tolerability of Velusetrag for the Treatment of Diabetic or Idiopathic
Brief Summary: Study 0099 explores the efficacy and safety of multiple doses of velusetrag in the treatment of symptoms in subjects with diabetic or idiopathic gastroparesis. Three dose levels of velusetrag will be evaluated and compared to placebo for approximately 12 weeks of therapy. In addition, the study will be used to evaluate the psychometric properties of the Gastroparesis Rating Scale (GRS), a daily patient-reported outcome (PRO) measure.
Detailed Summary:
Sponsor: Theravance Biopharma R & D, Inc.
Current Primary Outcome: 7-day mean GCSI-24H (Gastroparesis Cardinal Symptoms Index) composite score [ Time Frame: At Week 4 ]
Original Primary Outcome: 7-day mean GCSI-DD composite score [ Time Frame: At Week 4 ]
Current Secondary Outcome:
- Gastric emptying half-time [ Time Frame: At Week 4 ]
- Adverse events [ Time Frame: 103 days ]
Original Secondary Outcome:
- Gastric emptying half-time using 99mTc gastric emptying scintigraphy [ Time Frame: At Week 4 ]
- Gastric motility breath test half-time using the 13C octanoate breath test [ Time Frame: At Week 12 ]
- Adverse events [ Time Frame: 103 days ]
Information By: Theravance Biopharma R & D, Inc.
Dates:
Date Received: October 14, 2014
Date Started: December 2014
Date Completion: June 2017
Last Updated: March 14, 2017
Last Verified: March 2017
