NCT00765895

Nortriptyline for Idiopathic Gastroparesis

Nortriptyline for Idiopathic Gastroparesis: A Multicenter, Randomized, Double-Masked, Placebo-Controlled Trial (NORIG)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NIH
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Idiopathic Gastroparesis

Interventions

Type	Name	Description
DRUG	Nortriptyline Hydrochloride	Nortriptyline; 10 mg, one capsule, po qhs (by mouth at bedtime each night) x 3 weeks, f03 visit, 25 mg, one capsule, po qhs x 3 weeks, f06 visit, 50 mg, two capsules, po qhs x 3 weeks, f09 visit, 75 mg, three capsules, po qhs x 6 weeks, f15 visit: taper study drug by one capsule a week, off study drug for the last week
DRUG	Placebo (for nortriptyline)	Placebo (for nortriptyline), 10 mg, one capsule, po qhs x 3 weeks, f03 visit, 25 mg, one capsule, po qhs x 3 weeks;

Timeline

• Start date: 2009-01-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2008-10-03
• Last updated: 2020-05-14
• Results posted: 2015-04-16

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study