Phase 3
Completed N=53
Multicenter Study to Evaluate the Efficacy and Safety of Metoclopramide Nasal Spray in Men With Diabetic Gastroparesis
Diabetic Gastroparesis
Source: ClinicalTrials.gov NCT02025751 ↗
Enrolled (actual)
53
Serious AEs
5.7%
Results posted
Jul 2020
Primary outcomePrimary: Gastroparesis Symptom Assessment (GSA), a Patient Reported Outcome Measure — -0.751; -0.657 score on a scale — p=0.597
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this study is evaluate the safety and efficacy of Metoclopramide Nasal Spray compared to placebo in reducing the symptoms of diabetic gastroparesis in adult men.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Gastroparesis Symptom Assessment (GSA), a Patient Reported Outcome Measure |
-0.751; -0.657 | 0.597 |
Eligibility Criteria
Inclusion Criteria
- Male subjects between the ages of 18 and 75 years
- Willingness and ability to give written informed consent
- The ability to read, understand and speak English
- Prior diagnosis of Type 1 or Type 2 diabetes
- Diagnosis of diabetic gastroparesis with confirmation of delayed gastric emptying
- A mean daily gastroparesis symptom score of ≥1.4 and ≤3.5 prior to randomization
- Willingness to discontinue current treatment for diabetic gastroparesis and to avoid all proscribed (excluded) medications, as specified by the protocol, for the duration of the study
Exclusion Criteria
- Gastric bypass, gastric banding, gastric pacemaker, post surgical causes of gastroparesis and disorders known to be associated with abnormal gastrointestinal motility
- A history of allergic or adverse responses, including, but not limited to, acute dystonic reactions and tardive dyskinesia, to metoclopramide or any comparable or similar product
- A history of, or physical findings suggestive of, tardive dyskinesia
- A history of epilepsy or currently using and unwilling or unable stop other drugs known to be associated with extrapyramidal reactions at screening
- Malignancy (with the exception of treated squamous cell or basal cell carcinoma of the skin) currently present, initially diagnosed or recurring within five (5) years of screening
- Renal dysfunction calculated as creatinine clearance (CrCl) 11.5% at screening
Data sourced from ClinicalTrials.gov (NCT02025751). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.