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Study of Promethazine for Treatment of Diabetic Gastroparesis

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ClinicalTrials.gov Identifier: NCT02130622
Recruitment Status : Recruiting
First Posted : May 5, 2014
Last Update Posted : May 12, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Diabetic Gastroparesis Drug: Promethazine Drug: Sugar pill Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pilot, Randomized, Double-blind, Placebo-controlled Trial of Promethazine for Treatment of Diabetic Gastroparesis.
Actual Study Start Date : July 2014
Estimated Primary Completion Date : December 2020


Arms and Interventions

Arm Intervention/treatment
Experimental: Promethazine
Promethazine 12.5 mg P.O. t.i.d. for 4 weeks
Drug: Promethazine
Other Name: Phenergan
Placebo Comparator: Sugar Pill
Placebo P.O. t.i.d. for 4 weeks
Drug: Sugar pill
Other Name: Placebo


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Occurrence of adverse events [ Time Frame: 4 weeks ]
  2. Use of rescue medication [ Time Frame: 4 weeks ]
    Frequency of use of the "rescue medication" meclizine

  3. The impact on work activity as measured by the Work Productivity and Activity Impairment Questionnaire. (WPAI). [ Time Frame: 4 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02130622


Contacts
Contact: Jessica I Chevalier 603-653-9033 Jessica.I.Chevalier@hitchcock.org

Locations
United States, New Hampshire
Dartmouth-Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Jessica I. Chevalier    603-653-9033    Jessica.I.Chevalier@hitchcock.org   
Contact: Anna M Haron    603-653-3667    Anna.M.Haron@hitchcock.org   
Principal Investigator: Brian E Lacy, MD, PhD         
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
American College of Gastroenterology
Investigators
Principal Investigator: Brian E. Lacy, MD Dartmouth-Hitchcock Medical Center
More Information

Publications:

Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT02130622     History of Changes
Other Study ID Numbers: D14076
First Posted: May 5, 2014    Key Record Dates
Last Update Posted: May 12, 2017
Last Verified: May 2017

Keywords provided by Dartmouth-Hitchcock Medical Center:
Diabetic Gastroparesis
Promethazine

Additional relevant MeSH terms:
Gastroparesis
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms
Promethazine
Diphenhydramine
Antipruritics
Dermatologic Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Allergic Agents
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Peripheral Nervous System Agents
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Hypnotics and Sedatives