NCT00765895 (NORIG) is a Phase 3 clinical trial of Nortriptyline Hydrochloride in Idiopathic Gastroparesis, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

Who is sponsoring NCT00765895?

NCT00765895 is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

What drugs are being tested in NCT00765895?

Interventions in NCT00765895: Nortriptyline Hydrochloride, Placebo (for nortriptyline).

What condition does NCT00765895 study?

NCT00765895 studies Idiopathic Gastroparesis.

Is NCT00765895 still recruiting?

NCT00765895 is currently completed. Last updated 30 April 2020.

Are results published for NCT00765895?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2020-04-30 · How we verify

NCT00765895: NORIG

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 3 Results posted Last updated 30 April 2020

What this trial tests

Phase 3 trial testing Nortriptyline Hydrochloride in Idiopathic Gastroparesis in 130 participants. Completed in 1 October 2012.

Timeline

1 January 2009

Primary endpoint
1 October 2012

1 October 2012

Quick facts

Lead sponsor	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	130
Start date	1 January 2009
Primary completion	1 October 2012
Estimated completion	1 October 2012
Sites	7 locations across United States

Drugs / interventions tested

Nortriptyline Hydrochloride (NORTRIPTYLINE HYDROCHLORIDE) — full drug profile →
Placebo (for nortriptyline) — full drug profile →

Conditions studied

Idiopathic Gastroparesis — all drugs for Idiopathic Gastroparesis →

Sponsor

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

Who can join

Adults 21 to 65, any sex, with Idiopathic Gastroparesis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

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.

Sponsor's own description

The principal objective of this multicenter, randomized, placebo-controlled trial is to evaluate whether treatment with nortriptyline will improve gastroparesis symptoms compared with placebo.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Effect of nortriptyline on symptoms of idiopathic gastroparesis: the NORIG randomized clinical trial.
Parkman HP, Van Natta ML, Abell TL, McCallum RW, et al · · 2013 · cited 120× · PMID 24368464 · DOI 10.1001/jama.2013.282833

Verify or expand the search:

Other trials of Nortriptyline Hydrochloride

Trials testing the same drug.

NCT02881125 — Paclitaxel and Nortriptyline Hydrochloride in Treating Patients With Relapsed Small Cell Carcinoma · Phase 1 · completed
NCT07527481 — Nortriptyline and the Risk of Serious Adverse Events · completed

Other recruiting trials for Idiopathic Gastroparesis

Currently open trials in the same condition.

NCT06899217 — A Study to Evaluate the Efficacy and Safety of CIN-102 (Deudomperidone) in Adult Subjects With Idiopathic Gastroparesis. · Phase 2 · active not recruiting

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

Trials by the same sponsor.

NCT07313787 — Effects of Meal Macronutrients on Postprandial Lipids · Phase 2 · not yet recruiting
NCT07388537 — Evaluation of the Clinical Spectrum of Diabetes and Obesity in Youth and Adults · not yet recruiting
NCT05713799 — Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity · Phase 2 · not yet recruiting
NCT05722210 — Prevalence and Development of Liver Dysfunction in Hematopoietic Stem Cell Transplant · not yet recruiting
NCT07191561 — Hepatic Lipid Metabolism-Alcohol Use Disorder · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00765895 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Last refreshed: 30 April 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00765895.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing