Study of Promethazine for Treatment of Diabetic Gastroparesis

July 9, 2018 updated by: Dartmouth-Hitchcock Medical Center

A Pilot, Randomized, Double-blind, Placebo-controlled Trial 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 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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • adult patients 18-65 years of age
  • clinical diagnosis of diabetic gastroparesis.
  • EGD without evidence of gastric outlet obstruction within the past five years
  • gastric emptying scintigraphy test demonstrating >10% solid food retention at 4 hours within the past three years.

Exclusion Criteria:

  • the inability or unwillingness to provide informed consent
  • currently pregnant or breast feeding
  • prior placement of a gastric stimulator
  • pyloric botulinum toxin injection within the past 12 months
  • prior gastric surgery
  • history of a connective tissue disorder
  • use of narcotic medication within the past four weeks
  • hemoglobin A1C >12 mg/dL within the past 3 months
  • current or recent (within past 4 weeks) use of promethazine, metoclopramide or domperidone
  • hypersensitivity or prior adverse reaction to promethazine
  • concomitant use of phenothiazines (i.e. prochlorperazine, chlorpromazine) or other agents likely to increase extrapyramidal reactions
  • concomitant use of tiotropium or ipratropium
  • narrow angle glaucoma
  • urinary retention
  • Parkinson's disease
  • significant psychiatric disease
  • history of seizure.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Promethazine
Promethazine 12.5 mg P.O. t.i.d. for 4 weeks
Drug: Promethazine
Other Names:
  • Phenergan
Placebo Comparator: Sugar Pill
Placebo P.O. t.i.d. for 4 weeks
Drug: Sugar pill
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Patient-reported Symptoms as Measured by the Gastroparesis Cardinal Symptom Index Score (GCSI, 14) From Week 0 to Week 4.
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of Adverse Events
Time Frame: 4 weeks
4 weeks
Use of Rescue Medication
Time Frame: 4 weeks
Frequency of use of the "rescue medication" meclizine
4 weeks
The Impact on Work Activity as Measured by the Work Productivity and Activity Impairment Questionnaire. (WPAI).
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dartmouth-Hitchcock Medical Center

Collaborators

American College of Gastroenterology

Investigators

  • Principal Investigator: Brian E. Lacy, MD, Dartmouth-Hitchcock Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2014

Primary Completion (Actual)

May 14, 2015

Study Completion (Actual)

May 14, 2015

Study Registration Dates

First Submitted

May 1, 2014

First Submitted That Met QC Criteria

May 2, 2014

First Posted (Estimate)

May 5, 2014

Study Record Updates

Last Update Posted (Actual)

August 7, 2018

Last Update Submitted That Met QC Criteria

July 9, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D14076

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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