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| Sponsor: | Evoke Pharma |
|---|---|
| Information provided by: | Evoke Pharma |
| ClinicalTrials.gov Identifier: | NCT00845858 |
Purpose
To evaluate the safety and the effectiveness of two doses of metoclopramide nasal spray solution, 10 mg and 14 mg, compared to placebo in reducing the symptoms of diabetic gastroparesis.
| Condition | Intervention | Phase |
|---|---|---|
|
Gastroparesis Diabetic Gastroparesis Diabetes Diabetes Mellitus Delayed Gastric Emptying |
Drug: metoclopramide Drug: Placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Dose-Ranging Clinical Study to Evaluate the Efficacy and Safety of Metoclopramide Nasal Spray Solution in Diabetic Subjects With Gastroparesis |
| Estimated Enrollment: | 225 |
| Study Start Date: | April 2009 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Metoclopramide Nasal Spray 10 mg |
Drug: metoclopramide
30 minutes before meals and at bedtime for 4 weeks
Other Name: Reglan
|
| Active Comparator: Metoclopramide Nasal Spray 14 mg |
Drug: metoclopramide
30 minutes before meals and at bedtime for 4 weeks
Other Name: Reglan
|
| Placebo Comparator: Placebo Nasal Spray |
Drug: Placebo
30 minutes before meals and at bedtime
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
Contacts and Locations
Show 65 Study Locations
More Information
| Responsible Party: | Evoke, Evoke Pharma |
| ClinicalTrials.gov Identifier: | NCT00845858 History of Changes |
| Other Study ID Numbers: | METO-IN-002 |
| Study First Received: | February 17, 2009 |
| Last Updated: | July 18, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Gastroparesis Diabetic Gastroparesis Diabetes Diabetes Mellitus Delayed Gastric Emptying |
|
Diabetes Mellitus Gastroparesis Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Stomach Diseases Gastrointestinal Diseases Digestive System Diseases Paralysis Neurologic Manifestations Signs and Symptoms Metoclopramide |
Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Gastrointestinal Agents Dopamine Antagonists Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |