Trial Outcomes & Findings for Multicenter Study to Evaluate the Efficacy and Safety of Metoclopramide Nasal Spray in Men With Diabetic Gastroparesis (NCT NCT02025751)
NCT ID: NCT02025751
Last Updated: 2020-07-07
Results Overview
Change from the Baseline Period to Week 4 of the Treatment Period in the mean daily Gastroparesis Symptom Assessment (GSA) total score for subjects receiving Metoclopramide Nasal Spray 10 mg versus subjects receiving placebo. The GSA minimum value is 0 (no symptoms) and the maximum value is 4 (very severe symptoms). A higher score is a worse outcome.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
53 participants
Primary outcome timeframe
Change from the Baseline Period to Week 4 in Daily Total Score (Intent-to Treat Population)
Results posted on
2020-07-07
Participant Flow
Participant milestones
| Measure |
Metoclopramide Nasal Spray
Metoclopramide Nasal Spray 10 mg, 30 minutes before meals and at bedtime (QID) for 4 weeks
Metoclopramide Nasal Spray: One 10 mg spray dose 30 minutes before meals and before bed for 28 days (QID)
|
Placebo Nasal Spray
Placebo Nasal Spray 30 minutes before meals and at bedtime (QID) for 4 weeks
Placebo Nasal Spray: One placebo spray dose 30 minutes before meals and before bed for 28 days (QID)
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
27
|
|
Overall Study
COMPLETED
|
25
|
24
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
Metoclopramide Nasal Spray
Metoclopramide Nasal Spray 10 mg, 30 minutes before meals and at bedtime (QID) for 4 weeks
Metoclopramide Nasal Spray: One 10 mg spray dose 30 minutes before meals and before bed for 28 days (QID)
|
Placebo Nasal Spray
Placebo Nasal Spray 30 minutes before meals and at bedtime (QID) for 4 weeks
Placebo Nasal Spray: One placebo spray dose 30 minutes before meals and before bed for 28 days (QID)
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Multicenter Study to Evaluate the Efficacy and Safety of Metoclopramide Nasal Spray in Men With Diabetic Gastroparesis
Baseline characteristics by cohort
| Measure |
Metoclopramide Nasal Spray
n=26 Participants
Metoclopramide Nasal Spray 10 mg, 30 minutes before meals and at bedtime (QID) for 4 weeks
Metoclopramide Nasal Spray: One 10 mg spray dose 30 minutes before meals and before bed for 28 days (QID)
|
Placebo Nasal Spray
n=27 Participants
Placebo Nasal Spray 30 minutes before meals and at bedtime (QID) for 4 weeks
Placebo Nasal Spray: One placebo spray dose 30 minutes before meals and before bed for 28 days (QID)
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=5 Participants
|
27 participants
n=7 Participants
|
53 participants
n=5 Participants
|
|
Gastroparesis Symptom Assessment
|
2.096 units on a scale
STANDARD_DEVIATION 0.4801 • n=5 Participants
|
2.235 units on a scale
STANDARD_DEVIATION 0.4097 • n=7 Participants
|
2.167 units on a scale
STANDARD_DEVIATION 0.4468 • n=5 Participants
|
PRIMARY outcome
Timeframe: Change from the Baseline Period to Week 4 in Daily Total Score (Intent-to Treat Population)Change from the Baseline Period to Week 4 of the Treatment Period in the mean daily Gastroparesis Symptom Assessment (GSA) total score for subjects receiving Metoclopramide Nasal Spray 10 mg versus subjects receiving placebo. The GSA minimum value is 0 (no symptoms) and the maximum value is 4 (very severe symptoms). A higher score is a worse outcome.
Outcome measures
| Measure |
Metoclopramide Nasal Spray
n=26 Participants
Metoclopramide Nasal Spray 10 mg, 30 minutes before meals and at bedtime (QID) for 4 weeks
Metoclopramide Nasal Spray: One 10 mg spray dose 30 minutes before meals and before bed for 28 days (QID)
|
Placebo Nasal Spray
n=27 Participants
Placebo Nasal Spray 30 minutes before meals and at bedtime (QID) for 4 weeks
Placebo Nasal Spray: One placebo spray dose 30 minutes before meals and before bed for 28 days (QID)
|
|---|---|---|
|
Gastroparesis Symptom Assessment (GSA), a Patient Reported Outcome Measure
|
-0.751 score on a scale
Standard Deviation 0.4673
|
-0.657 score on a scale
Standard Deviation 0.9042
|
Adverse Events
Metoclopramide Nasal Spray
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo Nasal Spray
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Metoclopramide Nasal Spray
n=26 participants at risk
Metoclopramide Nasal Spray 10 mg, 30 minutes before meals and at bedtime (QID) for 4 weeks
Metoclopramide Nasal Spray: One 10 mg spray dose 30 minutes before meals and before bed for 28 days (QID)
|
Placebo Nasal Spray
n=27 participants at risk
Placebo Nasal Spray 30 minutes before meals and at bedtime (QID) for 4 weeks
Placebo Nasal Spray: One placebo spray dose 30 minutes before meals and before bed for 28 days (QID)
|
|---|---|---|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/26 • 4 weeks
|
3.7%
1/27 • Number of events 1 • 4 weeks
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/26 • 4 weeks
|
3.7%
1/27 • Number of events 1 • 4 weeks
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/26 • 4 weeks
|
3.7%
1/27 • Number of events 1 • 4 weeks
|
Other adverse events
| Measure |
Metoclopramide Nasal Spray
n=26 participants at risk
Metoclopramide Nasal Spray 10 mg, 30 minutes before meals and at bedtime (QID) for 4 weeks
Metoclopramide Nasal Spray: One 10 mg spray dose 30 minutes before meals and before bed for 28 days (QID)
|
Placebo Nasal Spray
n=27 participants at risk
Placebo Nasal Spray 30 minutes before meals and at bedtime (QID) for 4 weeks
Placebo Nasal Spray: One placebo spray dose 30 minutes before meals and before bed for 28 days (QID)
|
|---|---|---|
|
Investigations
Liver palpable
|
0.00%
0/26 • 4 weeks
|
3.7%
1/27 • Number of events 1 • 4 weeks
|
|
Investigations
Platelet count decreased
|
3.8%
1/26 • Number of events 1 • 4 weeks
|
0.00%
0/27 • 4 weeks
|
|
General disorders
Malaise
|
0.00%
0/26 • 4 weeks
|
3.7%
1/27 • Number of events 1 • 4 weeks
|
|
General disorders
Pyrexia
|
0.00%
0/26 • 4 weeks
|
3.7%
1/27 • Number of events 1 • 4 weeks
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
3.8%
1/26 • Number of events 1 • 4 weeks
|
0.00%
0/27 • 4 weeks
|
|
Psychiatric disorders
Depression
|
0.00%
0/26 • 4 weeks
|
3.7%
1/27 • Number of events 1 • 4 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/26 • 4 weeks
|
3.7%
1/27 • Number of events 1 • 4 weeks
|
|
Gastrointestinal disorders
Ascites
|
3.8%
1/26 • Number of events 1 • 4 weeks
|
0.00%
0/27 • 4 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
3.8%
1/26 • Number of events 1 • 4 weeks
|
0.00%
0/27 • 4 weeks
|
|
Gastrointestinal disorders
Nausea
|
3.8%
1/26 • Number of events 1 • 4 weeks
|
0.00%
0/27 • 4 weeks
|
|
Gastrointestinal disorders
Oesophagitis ulcerative
|
0.00%
0/26 • 4 weeks
|
3.7%
1/27 • Number of events 1 • 4 weeks
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/26 • 4 weeks
|
3.7%
1/27 • Number of events 1 • 4 weeks
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
3.8%
1/26 • Number of events 1 • 4 weeks
|
0.00%
0/27 • 4 weeks
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/26 • 4 weeks
|
3.7%
1/27 • Number of events 1 • 4 weeks
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.00%
0/26 • 4 weeks
|
3.7%
1/27 • Number of events 1 • 4 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
3.8%
1/26 • Number of events 1 • 4 weeks
|
3.7%
1/27 • Number of events 1 • 4 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/26 • 4 weeks
|
3.7%
1/27 • Number of events 1 • 4 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.8%
1/26 • Number of events 1 • 4 weeks
|
0.00%
0/27 • 4 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
3.8%
1/26 • Number of events 1 • 4 weeks
|
0.00%
0/27 • 4 weeks
|
|
Infections and infestations
Abscess limb
|
0.00%
0/26 • 4 weeks
|
3.7%
1/27 • Number of events 1 • 4 weeks
|
|
Infections and infestations
Nasopharyngitis
|
3.8%
1/26 • Number of events 1 • 4 weeks
|
0.00%
0/27 • 4 weeks
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/26 • 4 weeks
|
3.7%
1/27 • Number of events 1 • 4 weeks
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/26 • 4 weeks
|
3.7%
1/27 • Number of events 1 • 4 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
3.8%
1/26 • Number of events 1 • 4 weeks
|
0.00%
0/27 • 4 weeks
|
|
Vascular disorders
Hypertension
|
0.00%
0/26 • 4 weeks
|
3.7%
1/27 • Number of events 1 • 4 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place