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NCT00765895 · ClinicalTrials.gov registry record · Phase 3
Nortriptyline for Idiopathic Gastroparesis
A Phase 3 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- Phase 3
- Development phase
- 130
- Enrollment target
NCT00765895: Completed Phase 3 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
NCT00765895 is a Phase 3 study that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 130 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00765895, a Phase 3 study, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 130 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG Nortriptyline Hydrochloride
- DRUG Placebo (for nortriptyline)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 2009-01 |
| Est. Completion | 2012-10 |
| Phase | Phase 3 |
What the finished NCT00765895 record still lists
NCT00765895 is an interventional study that assigns participants to a tested intervention. The registered 130 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 2 interventions - of which Nortriptyline Hydrochloride is the first listed.
NCT00765895 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00765895 about?
NCT00765895 is a clinical study titled "Nortriptyline for Idiopathic Gastroparesis". The principal objective of this multicenter, randomized, placebo-controlled trial is to evaluate whether treatment with nortriptyline will improve gastroparesis symptoms compared with placebo.
What is the current status of trial NCT00765895?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 130 participants. The study started on 2009-01. Estimated completion is 2012-10.
What interventions are being tested in trial NCT00765895?
The interventions under investigation include: Nortriptyline Hydrochloride (DRUG), Placebo (for nortriptyline) (DRUG).
Who is sponsoring clinical trial NCT00765895?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00765895's enrollment target sits among peer trials
130 1594th of 2000 higher than 404 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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