Study of Promethazine for Treatment of Diabetic Gastroparesis

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetic Gastroparesis

Intervention / Treatment
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* Drug: Promethazine
* Drug: Sugar pill


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Promethazine<br>Promethazine 12.5 mg P.O. t.i.d. for 4 weeks | Drug: Promethazine<br> <br> * Other names: Phenergan;|
| Placebo Comparator: Sugar Pill<br>Placebo P.O. t.i.d. for 4 weeks | Drug: Sugar pill<br> <br> * Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of Adverse Events |  | 4 weeks | 
| Use of Rescue Medication | 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). |  | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic Gastroparesis, Promethazine