Nortriptyline for Idiopathic Gastroparesis

NCT00765895 | Completed Phase 3 Results DMC FDA Drug

• 7 other identifiers: U01DK074008 NORIG1U01DK0739831U01DK0739751U01DK0739851U01DK0740071U01DK0739741U01DK074008
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 7

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.

Conditions

Idiopathic Gastroparesis

Keywords

idiopathic gastroparesis

Outcome Measures

Primary Outcomes (1)

• Decrease From the Baseline GCSI of at Least 50% on Any Two Consecutive Follow-up Visits

  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.

  at end of treatment, 15 weeks from baseline assessment

Study Arms (2)

Nortriptyline

ACTIVE COMPARATOR

Nortriptyline Hydrochloride dose escalation from 10 mg to 75 mg

Drug: Nortriptyline Hydrochloride

Placebo (for nortriptyline)

PLACEBO COMPARATOR

No treatment

Drug: Placebo (for nortriptyline)

Interventions

Nortriptyline Hydrochloride DRUG

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

Also known as: Nortriptyline HCl, Pamelor

Nortriptyline

Placebo (for nortriptyline) DRUG

Placebo (for nortriptyline), 10 mg, one capsule, po qhs x 3 weeks, f03 visit, 25 mg, one capsule, po qhs x 3 weeks;

Placebo (for nortriptyline)

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 21 through 65 years old at registration
• Documentation of delayed gastric emptying on gastric emptying scintigraphy within 2 years of registration, defined as greater than 60% retention at 2 hours or greater than 10% retention at 4 hours
• Symptoms of gastroparesis for at least 6 months (does not have to be contiguous) prior to registration with Gastroparesis Cardinal Symptom Index (GCSI) score of 21 or greater
• Negative upper endoscopy or upper GI series within 2 years of registration

You may not qualify if:

• Normal gastric emptying confirmed with scintigraphy
• Diabetic gastroparesis or post-surgical gastroparesis including fundoplication
• Another active disorder which could explain symptoms in the opinion of the investigator
• History of significant cardiac arrhythmias and/or prolonged QTc
• History of seizures
• Use of narcotics more than 3 days per week
• Use of tricyclic antidepressants for refractory symptoms of gastroparesis within 6 weeks prior to randomization
• Use of strongly anticholinergic medications
• Use of calcium channel blockers
• Use of erythromycin
• Clear history of failed trial of nortriptyline use for gastroparetic symptoms
• Symptoms of primary depression or suicidal ideation
• Contraindications to nortriptyline:
• hypersensitivity or allergy to any tricyclic antidepressant drug
• concomitant therapy with a monoamine oxidase inhibitor (MAOI)

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead

Study Sites (7)

California Pacific Medical Center

San Francisco, California, 94115, United States

Location

Stanford University

Stanford, California, 94305-5187, United States

Location

University of Michigan Medical Center

Ann Arbor, Michigan, 48109, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

Texas Tech University Health Sciences Center

El Paso, Texas, 79905, United States

Location

Related Publications (1)

• Parkman HP, Van Natta ML, Abell TL, McCallum RW, Sarosiek I, Nguyen L, Snape WJ, Koch KL, Hasler WL, Farrugia G, Lee L, Unalp-Arida A, Tonascia J, Hamilton F, Pasricha PJ. Effect of nortriptyline on symptoms of idiopathic gastroparesis: the NORIG randomized clinical trial. JAMA. 2013 Dec 25;310(24):2640-9. doi: 10.1001/jama.2013.282833.

  PMID: 24368464 DERIVED

Related Links

• Click here for information on gastroparesis research

MeSH Terms

Interventions

Nortriptyline

Intervention Hierarchy (Ancestors)

Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Results Point of Contact

• Title: Mark Van Natta
• Organization: Johns Hopkins Data Coordinating Centers

mvannat1@jhu.edu

410-614-1362

Study Officials

• Frank Hamilton, MD, MPH

  National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2008
• First Posted: October 3, 2008
• Study Start: January 1, 2009
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: May 14, 2020
• Results First Posted: April 16, 2015

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share

Locations

US (7)