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NCT02130622 · ClinicalTrials.gov registry record · Phase 2
Study of Promethazine for Treatment of Diabetic Gastroparesis
A Phase 2 study, sponsored by Dartmouth-Hitchcock Medical Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 3
- Enrollment target
NCT02130622 is a Phase 2 study that was terminated before completion, run by Dartmouth-Hitchcock Medical Center. The registered enrollment target is 3 participants.
The verdict
NCT02130622, a Phase 2 study, was terminated before completion, sponsored by Dartmouth-Hitchcock Medical Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 3 participants
- Enrollment target
Study Summary
Adult diabetic patients (ages 18-65) with gastric emptying scintigraphy-confirmed delayed gastric emptying will be recruited to participate in the study. Using double-blinded methodology, study participants will be randomly assigned to one of two treatment arms: promethazine 12.5 mg three times daily for 28 days or placebo three times daily for 28 days. The primary outcome will be the change in gastroparesis symptom severity, as measured by the Gastroparesis Cardinal Symptom Index (GCSI) at four weeks compared to baseline. Participants will be seen for a clinic evaluation at weeks 0, 2 and 4, during which symptom scores, adverse events and treatment compliance will be assessed. It is hypothesized promethazine treatment will be superior to placebo in improving symptoms of gastroparesis.
Interventions
- DRUG Sugar pill
- DRUG Promethazine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2014-07 |
| Est. Completion | 2015-05-14 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02130622
The ClinicalTrials.gov registry entry for NCT02130622 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Dartmouth-Hitchcock Medical Center, which has 427 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Sugar pill is the first listed.
NCT02130622 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02130622 about?
NCT02130622 is a clinical study titled "Study of Promethazine for Treatment of Diabetic Gastroparesis". Adult diabetic patients (ages 18-65) with gastric emptying scintigraphy-confirmed delayed gastric emptying will be recruited to participate in the study. Using double-blinded methodology, study participants will be randomly assigned to one of two treatment arms: promethazine 12.5 mg three times dail...
What is the current status of trial NCT02130622?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2014-07. Estimated completion is 2015-05-14.
What interventions are being tested in trial NCT02130622?
The interventions under investigation include: Sugar pill (DRUG), Promethazine (DRUG).
Who is sponsoring clinical trial NCT02130622?
This trial is sponsored by Dartmouth-Hitchcock Medical Center, which has 427 total clinical trials registered on ClinicalTrials.gov.
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