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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: Clinical Trial Phase 2 study, sponsored by Dartmouth-Hitchcock Medical Center.

NCT02130622 is a Phase 2 study that was terminated before completion, run by Dartmouth-Hitchcock Medical Center. The registered enrollment target is 3 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 3 participants
Start Date 2014-07
Est. Completion 2015-05-14
Phase Phase 2
Dartmouth-Hitchcock Medical Center

427 total trials

Why NCT02130622 stopped before completion

NCT02130622 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 2 interventions - of which Sugar pill is the first listed.

NCT02130622 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT02130622's enrollment target sits among peer trials

3 2001st of 2000 the lowest of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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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Source: ClinicalTrials.gov NCT02130622, the US trial registry maintained by the National Library of Medicine. NCT02130622 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.