Diabetic Gastroparesis
Conditions
Keywords
Diabetic Gastroparesis, Promethazine
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.
Interventions
DRUGPromethazine
DRUGSugar pill
Sponsors
American College of Gastroenterology
Dartmouth-Hitchcock Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of Adverse Events | 4 weeks | — |
| Use of Rescue Medication | 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). | 4 weeks | — |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from the gastroenterology clinic at Dartmouth-Hitchcock Medical Center at the time of routine appointments.
Participants by arm
| Arm | Count |
|---|---|
| Promethazine Promethazine 12.5 mg P.O. t.i.d. for 4 weeks
Promethazine | 2 |
| Sugar Pill Placebo P.O. t.i.d. for 4 weeks
Sugar pill | 1 |
| Total | 3 |
Baseline characteristics
| Characteristic | Promethazine | Sugar Pill | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 1 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 1 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 1 Participants | 3 Participants |
| Region of Enrollment United States | 2 Participants | 1 Participants | 3 Participants |
| Sex: Female, Male Female | 2 Participants | 1 Participants | 3 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 1 |
| other Total, other adverse events | 1 / 2 | 0 / 1 |
| serious Total, serious adverse events | 0 / 2 | 0 / 1 |
Outcome results
Primary
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
Population: Insufficient recruitment resulting in insufficient data to analyze
Secondary
Occurrence of Adverse Events
Time frame: 4 weeks
Population: Insufficient recruitment resulting in insufficient data to analyze
Secondary
The Impact on Work Activity as Measured by the Work Productivity and Activity Impairment Questionnaire. (WPAI).
Time frame: 4 weeks
Population: Insufficient recruitment resulting in insufficient data to analyze
Secondary
Use of Rescue Medication
Frequency of use of the rescue medication meclizine
Time frame: 4 weeks
Population: Data not collected