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 ]

A decrease from the baseline Gastroparesis Cardinal Symptom Index (GCSI) score (sum of the 9 individual symptom scores) of at least 50% on any two consecutive follow-up visits during the 15 week treatment period with maximum tolerated study drug dose. The total score ranges from 0-45 with higher scores indicating greater symptom severity.


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