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Study of Promethazine for Treatment of Diabetic Gastroparesis

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ClinicalTrials.gov Identifier: NCT02130622
Recruitment Status : Terminated (Lack of recruitment)
First Posted : May 5, 2014
Results First Posted : May 17, 2018
Last Update Posted : August 7, 2018
Sponsor:
Collaborator:
American College of Gastroenterology
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center

Tracking Information
First Submitted Date  ICMJE May 1, 2014
First Posted Date  ICMJE May 5, 2014
Results First Submitted Date  ICMJE March 14, 2018
Results First Posted Date  ICMJE May 17, 2018
Last Update Posted Date August 7, 2018
Actual Study Start Date  ICMJE July 2014
Actual Primary Completion Date May 14, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 2, 2014)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02130622 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2014)
  • Occurrence of Adverse Events [ Time Frame: 4 weeks ]
  • Use of Rescue Medication [ Time Frame: 4 weeks ]
    Frequency of use of the "rescue medication" meclizine
  • The Impact on Work Activity as Measured by the Work Productivity and Activity Impairment Questionnaire. (WPAI). [ Time Frame: 4 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Promethazine for Treatment of Diabetic Gastroparesis
Official Title  ICMJE A Pilot, Randomized, Double-blind, Placebo-controlled Trial of Promethazine for Treatment of Diabetic Gastroparesis.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Diabetic Gastroparesis
Intervention  ICMJE
  • Drug: Promethazine
    Other Name: Phenergan
  • Drug: Sugar pill
    Other Name: Placebo
Study Arms  ICMJE
  • Experimental: Promethazine
    Promethazine 12.5 mg P.O. t.i.d. for 4 weeks
    Intervention: Drug: Promethazine
  • Placebo Comparator: Sugar Pill
    Placebo P.O. t.i.d. for 4 weeks
    Intervention: Drug: Sugar pill
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 19, 2018)
3
Original Estimated Enrollment  ICMJE
 (submitted: May 2, 2014)
24
Actual Study Completion Date  ICMJE May 14, 2015
Actual Primary Completion Date May 14, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02130622
Other Study ID Numbers  ICMJE D14076
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dartmouth-Hitchcock Medical Center
Study Sponsor  ICMJE Dartmouth-Hitchcock Medical Center
Collaborators  ICMJE American College of Gastroenterology
Investigators  ICMJE
Principal Investigator: Brian E. Lacy, MD Dartmouth-Hitchcock Medical Center
PRS Account Dartmouth-Hitchcock Medical Center
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP