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Efficacy and Safety of Metoclopramide Nasal Spray Solution in Diabetic Patients With Gastroparesis
This study is currently recruiting participants.
Verified by Evoke Pharma, July 2009
First Received: February 17, 2009   Last Updated: July 30, 2009   History of Changes
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

Resource links provided by NLM:


Further study details as provided by Evoke Pharma:

Primary Outcome Measures:
  • The primary efficacy endpoint is the change from Baseline to the last 7 days during the treatment period in the average GCSI-DD total score, in subjects receiving metoclopramide nasal spray versus subjects receiving placebo. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Abdominal pain and discomfort, hours of nausea, vomiting episodes, daily overall symptom severity, PAGI-SYM, use of rescue medication between groups, SF-12, disability scores, and OGS severity and overall treatment scores by subject and investigator [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

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
Criteria

Inclusion Criteria:

  1. Male subjects and non-pregnant, non-lactating female subjects between the ages of 18 and 75 years
  2. Willing and able to give written informed consent to participate
  3. The ability to read and understand English
  4. Prior diagnosis of Type 1 or Type 2 diabetes
  5. Diagnosis of diabetic gastroparesis previously documented within the last 12 months
  6. A mean daily Gastroparesis Cardinal Symptom Index-Daily Diary (GCSI-DD) Score of ≥ 2 and ≤ 4 for the 7 days prior to the Randomization visit (Visit 3, Day 0)
  7. Female subjects of childbearing potential, defined as not surgically sterile or at least 2 years postmenopausal, must agree to use one of the following forms of contraception from screening through the last dose of study drug: hormonal (oral, implant, or injection) begun >30 days prior to screening, barrier (condom, diaphragm with spermicide), intrauterine device (IUD), or vasectomized partner (6 months minimum)
  8. No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results (with the exception of lipid profile, glucose and hemoglobin A1c) during Screening which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results
  9. Willingness to discontinue current treatment for diabetic gastroparesis and to avoid all medications specified by the protocol for the duration of the study

Exclusion Criteria:

  1. Disorders known to be associated with abnormal gastrointestinal motility such as gastric ulcer, duodenal ulcer, severe gastritis, gastric cancer, amyloidosis, neuromuscular diseases (including Parkinson's disease), collagen vascular diseases, alcoholism, uremia, malnutrition, and untreated hypothyroidism or post surgical causes
  2. 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
  3. History of or physical findings suggestive of tardive dyskinesia
  4. Currently using any medication known to be associated with tardive dyskinesia
  5. History of allergy to any of the ingredients in the study drug formulation
  6. History of organ transplant, chronic pancreatitis, gross malabsorptive syndromes, celiac disease, or inflammatory bowel disease
  7. Malignancy (with the exception of basal cell carcinoma of the skin) currently present, initially diagnosed or recurring within 5 years of enrollment
  8. History of other clinically significant renal, hepatic, neurologic, hematologic, oncologic, pulmonary, psychiatric, cardiovascular or infectious disease, untreated hypothyroidism, or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results
  9. Have renal dysfunction calculated as creatinine clearance (CrCl) < 40 mL/min at Screening (Visit 1)
  10. Have a hemoglobin A1c > 10% at Screening
  11. Inability or unwillingness to stop using the following agents for 7 days during the Washout Period (Day -7 to Day -1) prior to Randomization (Visit 3, Day 0) and refrain from their use for the 4-week study period; metoclopramide, domperidone, tricyclic antidepressants, macrolide antibiotics, prokinetic agents, cholinergic agents, agents with significant anticholinergic effects, narcotic analgesics, orally administered B-agonists, spasmolytics, dopamine agonists, monoamine oxidase inhibitors, herbal supplements, fiber or bulking products, and laxatives
  12. Use of neurotoxins (e.g., botulinum type A or B) as a treatment for gastroparesis or delayed gastric emptying within 6 months of Screening
  13. Clinically significant abnormal findings or a QTc interval > 450 milliseconds (msec) on the Screening Visit electrocardiogram (ECG)
  14. Inability or unwillingness to stop using medications associated with Torsades de Pointes or a prolonged QT interval for 30 days prior to the initial symptom assessment and refrain from their use for the 4-week study period
  15. Female subjects who are trying to conceive, are pregnant, or are lactating
  16. Positive serum human chorionic gonadotropin (HCG) pregnancy test at Screening or a positive HCG urine test on Day 0 prior to administration of study drug for women of childbearing potential
  17. History of alcohol or drug abuse within the year prior to the Screening Visit, or current known evidence of substance dependence or abuse
  18. Participation in a clinical (investigational) trial or receipt of a non-FDA approved therapy within 30 days prior to the Screening Visit with the exception of domperidone
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00845858

  Show 27 Study Locations
Sponsors and Collaborators
Evoke Pharma
  More Information

No publications provided

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

Keywords provided by Evoke Pharma:
Gastroparesis
Diabetic Gastroparesis
Diabetes
Diabetes Mellitus
Delayed Gastric Emptying

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on February 08, 2010