Conditions: Idiopathic Gastroparesis
Keywords: idiopathic gastroparesis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 130
Healthy volunteers: no

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 description:

Arms:
arm 1: Nortriptyline Hydrochloride dose escalation from 10 mg to 75 mg arm 2: No treatment

Interventions: intervention 1: Nortriptyline Hydrochloride intervention 2: Placebo (for nortriptyline)
Intervention descriptions: intervention 1: 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 intervention 2: Placebo (for nortriptyline), 10 mg, one capsule, po qhs x 3 weeks, f03 visit, 25 mg, one capsule, po qhs x 3 weeks;

Protocol document: