Study of Promethazine for Treatment of Diabetic Gastroparesis

ClinicalTrials.gov ID: NCT02130622

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Official title

A Pilot, Randomized, Double-blind, Placebo-controlled Trial of Promethazine for Treatment of Diabetic Gastroparesis.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT02130622
Recruitment status: Terminated
Study type: Interventional
Phase: Phase 2
Lead sponsor: Dartmouth-Hitchcock Medical Center; Other
Enrollment: 3 participants

Conditions and interventions

Conditions

Diabetic Gastroparesis

Interventions

Promethazine Drug
Sugar pill Drug

Drug

Eligibility (public fields only)

Age range: 18 Years to 65 Years
Sex: All
Healthy volunteers: Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jul 2014 (Actual)
Primary completion: May 14, 2015 (Actual)
Completion: May 14, 2015 (Actual)
Last update posted: Aug 7, 2018

2014 – 2015

United States locations

U.S. sites: 1
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire	03756	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT02130622, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Aug 7, 2018 · Synced Nov 14, 2026