Trial · NCT00765895

Nortriptyline for Idiopathic Gastroparesis

NCT00765895, Phase 3, Completed, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); results first posted 2015-04-16

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Nortriptyline for Idiopathic Gastroparesis. Trials, record NCT00765895. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00765895

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Nortriptyline for Idiopathic Gastroparesis
NCT number: NCT00765895
Status: Completed
Phases: Phase 3
Enrollment: 130 participants, actual
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions: Idiopathic Gastroparesis
Interventions: Nortriptyline Hydrochloride, Placebo (for nortriptyline)
First posted: 2008-10-03
Last updated: 2020-05-14
Results first posted: 2015-04-16

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Decrease From the Baseline GCSI of at Least 50% on Any Two Consecutive Follow-up Visits	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.

Source ClinicalTrials.gov

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Decrease From the Baseline GCSI of at Least 50% on Any Two Consecutive Follow-up Visits	at end of treatment, 15 weeks from baseline assessment	intention to treat	participants	NUMBER

Source ClinicalTrials.gov

Results by group2

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Decrease From the Baseline GCSI of at Least 50% on Any Two Consecutive Follow-up Visits	Nortriptyline		15	95% Confidence Interval 13.5 to 35.2	participants
Decrease From the Baseline GCSI of at Least 50% on Any Two Consecutive Follow-up Visits	Placebo		14	95% Confidence Interval 12.3 to 33.5	participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Nortriptyline	65
Overall Study	STARTED	Placebo	65
Overall Study	COMPLETED	Nortriptyline	65
Overall Study	COMPLETED	Placebo	65
Overall Study	NOT COMPLETED	Nortriptyline	0
Overall Study	NOT COMPLETED	Placebo	0

Source ClinicalTrials.gov

Adverse events34

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Nervous system	Nervous system disorders	Nortriptyline	4	65	5
other	Nervous system	Nervous system disorders	Placebo	2	65	2
other	gastrointestinal events	Gastrointestinal disorders	Nortriptyline	3	65	5
other	gastrointestinal events	Gastrointestinal disorders	Placebo	5	65	6
other	cardiac	Cardiac disorders	Nortriptyline	5	65	6
other	cardiac	Cardiac disorders	Placebo	5	65	5
other	rash	Skin and subcutaneous tissue disorders	Nortriptyline	1	65	1
other	rash	Skin and subcutaneous tissue disorders	Placebo	0	65	0
other	renal and urinary events	Renal and urinary disorders	Nortriptyline	3	65	3
other	renal and urinary events	Renal and urinary disorders	Placebo	0	65	0

1 to 10 of 34Source ClinicalTrials.gov

See all 34 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Nortriptyline
Total, all-cause mortality	Placebo
Total, other adverse events	Nortriptyline	18	65
Total, other adverse events	Placebo	23	65
Total, serious adverse events	Nortriptyline	5	65
Total, serious adverse events	Placebo	1	65

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
24368464	DERIVED

Source PubMed

Grants6

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years	Source
U01DK073974	Exploration of Subtypes of Gastroparesis and Gastroparesis-like Symptoms based on Physiological Testing	MOSHIREE, BAHARAK	WAKE FOREST UNIVERSITY HEALTH SCIENCES	NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES	2006 to 2025	NIH RePORTER
U01DK073975	Temple University Gastroparesis Clinical Center	PARKMAN, HENRY PAUL	TEMPLE UNIV OF THE COMMONWEALTH	NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES	2006 to 2025	NIH RePORTER
U01DK073983	Advancing Science for the Diagnosis and Treatment of Gastroparesis	PASRICHA, PANKAJ J	MAYO CLINIC ARIZONA	NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES	2006 to 2025	NIH RePORTER
U01DK074007	U of L Clinical Center to Investigate the Pathogenesis, Etiology, and Treatment of Gastroparesis through the NIDDK Gastroparesis Consortium	ABELL, THOMAS LYMAN	UNIVERSITY OF LOUISVILLE	NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES	2006 to 2025	NIH RePORTER
U01DK073985	Gastroparesis Clinical Research Consortium-University of Michigan Clinical Center	HASLER, WILLIAM L	UNIVERSITY OF MICHIGAN AT ANN ARBOR	NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES	2006 to 2015	NIH RePORTER
U01DK074008	Gastroparesis Consortium Continuation-Data Coordinating Center	TONASCIA, JAMES A	JOHNS HOPKINS UNIVERSITY	NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES	2006 to 2015	NIH RePORTER

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Nortriptyline vs Placebo: Decrease From the Baseline GCSI of at Least 50% on Any Two Consecutive Follow-up Visits	Trial comparisons
Nortriptyline vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00765895

GET https://conductscience.org/api/trials/v1/NCT00765895/events?page=2

API reference For AI assistants