Clinical Trial: Nortriptyline for Idiopathic Gastroparesis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Nortriptyline for Idiopathic Gastroparesis: A Multicenter, Randomized, Double-Masked, Placebo-Controlled Trial (NORIG)
Brief Summary: The principal objective of this multicenter, randomized, placebo-controlled trial is to evaluate whether treatment with nortriptyline will improve gastroparesis symptoms compared with placebo.
Detailed Summary:
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Current Primary Outcome: Decrease From the Baseline GCSI of at Least 50% on Any Two Consecutive Follow-up Visits [ Time Frame: at end of treatment, 15 weeks from baseline assessment ]
Original Primary Outcome: The primary outcome measure is defined as a decrease from the baseline GCSI score of at least 50% on any 2 consecutive follow-up visits during the 15 week treatment period with maximum tolerated study drug dose. [ Time Frame: 17 weeks ]
Current Secondary Outcome:
Original Secondary Outcome:
Information By: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Dates:
Date Received: October 2, 2008
Date Started: January 2009
Date Completion:
Last Updated: April 15, 2015
Last Verified: April 2015