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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: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| 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 Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Metoclopramide Nasal Spray 10 mg: Active Comparator |
Drug: metoclopramide
30 minutes before meals and at bedtime for 4 weeks
|
| Metoclopramide Nasal Spray 14 mg: Active Comparator |
Drug: metoclopramide
30 minutes before meals and at bedtime for 4 weeks
|
| Placebo Nasal Spray: Placebo Comparator |
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 27 Study Locations
More Information
| Responsible Party: | Evoke Pharma ( Evoke ) |
| Study ID Numbers: | METO-IN-002 |
| Study First Received: | February 17, 2009 |
| Last Updated: | July 30, 2009 |
| ClinicalTrials.gov Identifier: | NCT00845858 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Gastroparesis Diabetic Gastroparesis Diabetes Diabetes Mellitus Delayed Gastric Emptying |
|
Neurotransmitter Agents Metabolic Diseases Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Physiological Effects of Drugs Gastrointestinal Agents Diabetes Mellitus Endocrine System Diseases Antiemetics Dopamine Antagonists Pharmacologic Actions Metoclopramide |
Paralysis Signs and Symptoms Stomach Diseases Digestive System Diseases Autonomic Agents Therapeutic Uses Neurologic Manifestations Dopamine Agents Peripheral Nervous System Agents Glucose Metabolism Disorders Central Nervous System Agents Gastroparesis |