Clinical trial NCT02130622: Study of Promethazine for Treatment of Diabetic Gastroparesis
Official title: A Pilot, Randomized, Double-blind, Placebo-controlled Trial of Promethazine for Treatment of Diabetic Gastroparesis.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Diabetic Gastroparesis
Keywords: Diabetic Gastroparesis
Promethazine
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: American College of Gastroenterology
First posted: 2014-05-05
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Change in Patient-reported Symptoms as Measured by the Gastroparesis Cardinal Symptom Index Score (GCSI, 14) From Week 0 to Week 4.
timeFrame: 4 weeks
Secondary outcomes:
measure: Occurrence of Adverse Events
timeFrame: 4 weeks
measure: Use of Rescue Medication
timeFrame: 4 weeks
measure: The Impact on Work Activity as Measured by the Work Productivity and Activity Impairment Questionnaire. (WPAI).
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Brian E. Lacy, MD
role: PRINCIPAL_INVESTIGATOR
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