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Trial record 8 of 9 for:    MECLIZINE

Study of Promethazine for Treatment of Diabetic Gastroparesis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Diabetic Gastroparesis
Interventions Drug: Promethazine
Drug: Sugar pill
Enrollment 3
Recruitment Details Participants were recruited from the gastroenterology clinic at Dartmouth-Hitchcock Medical Center at the time of routine appointments.
Pre-assignment Details  
Arm/Group Title Promethazine Sugar Pill
Hide Arm/Group Description

Promethazine 12.5 mg P.O. t.i.d. for 4 weeks

Promethazine

Placebo P.O. t.i.d. for 4 weeks

Sugar pill

Period Title: Overall Study
Started 2 1
Completed 2 1
Not Completed 0 0
Arm/Group Title Promethazine Sugar Pill Total
Hide Arm/Group Description

Promethazine 12.5 mg P.O. t.i.d. for 4 weeks

Promethazine

Placebo P.O. t.i.d. for 4 weeks

Sugar pill

Total of all reporting groups
Overall Number of Baseline Participants 2 1 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 1 participants 3 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
2
 100.0%
1
 100.0%
3
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 1 participants 3 participants
Female
2
 100.0%
1
 100.0%
3
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 1 participants 3 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
2
 100.0%
1
 100.0%
3
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 1 participants 3 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
2
 100.0%
1
 100.0%
3
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 2 participants 1 participants 3 participants
2
 100.0%
1
 100.0%
3
 100.0%
1.Primary Outcome
Title Change in Patient-reported Symptoms as Measured by the Gastroparesis Cardinal Symptom Index Score (GCSI, 14) From Week 0 to Week 4.
Hide Description [Not Specified]
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Insufficient recruitment resulting in insufficient data to analyze
Arm/Group Title Promethazine Sugar Pill
Hide Arm/Group Description:

Promethazine 12.5 mg P.O. t.i.d. for 4 weeks

Promethazine

Placebo P.O. t.i.d. for 4 weeks

Sugar pill

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Occurrence of Adverse Events
Hide Description [Not Specified]
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Insufficient recruitment resulting in insufficient data to analyze
Arm/Group Title Promethazine Sugar Pill
Hide Arm/Group Description:

Promethazine 12.5 mg P.O. t.i.d. for 4 weeks

Promethazine

Placebo P.O. t.i.d. for 4 weeks

Sugar pill

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Use of Rescue Medication
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected
Arm/Group Title Promethazine Sugar Pill
Hide Arm/Group Description:

Promethazine 12.5 mg P.O. t.i.d. for 4 weeks

Promethazine

Placebo P.O. t.i.d. for 4 weeks

Sugar pill

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title The Impact on Work Activity as Measured by the Work Productivity and Activity Impairment Questionnaire. (WPAI).
Hide Description [Not Specified]
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Insufficient recruitment resulting in insufficient data to analyze
Arm/Group Title Promethazine Sugar Pill
Hide Arm/Group Description:

Promethazine 12.5 mg P.O. t.i.d. for 4 weeks

Promethazine

Placebo P.O. t.i.d. for 4 weeks

Sugar pill

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame From date of ICF signature through study completion, approximately 5 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Promethazine Sugar Pill
Hide Arm/Group Description

Promethazine 12.5 mg P.O. t.i.d. for 4 weeks

Promethazine

Placebo P.O. t.i.d. for 4 weeks

Sugar pill

All-Cause Mortality
Promethazine Sugar Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)      0/1 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Promethazine Sugar Pill
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/2 (0.00%)      0/1 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Promethazine Sugar Pill
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/2 (50.00%)      0/1 (0.00%)    
Cardiac disorders     
Chest Pain *  1/2 (50.00%)  1 0/1 (0.00%)  0
Psychiatric disorders     
Auditory Hallucinations *  1/2 (50.00%)  2 0/1 (0.00%)  0
Nightmares *  1/2 (50.00%)  3 0/1 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Insufficient enrollment to provide study results. Study terminated before full enrollment due to lack of participant interest.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gastroenterology Research Team Lead
Organization: Dartmouth-Hitchcock
Phone: 603-653-9033
EMail: Jessica.I.Chevalier@hitchcock.org
Publications:
Layout table for additonal information
Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT02130622     History of Changes
Other Study ID Numbers: D14076
First Submitted: May 1, 2014
First Posted: May 5, 2014
Results First Submitted: March 14, 2018
Results First Posted: May 17, 2018
Last Update Posted: August 7, 2018