Efficacy and Safety of Metoclopramide Nasal Spray Solution in Diabetic Patients With Gastroparesis
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| ClinicalTrials.gov Identifier: NCT00845858 |
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Recruitment Status :
Completed
First Posted : February 18, 2009
Results First Posted : June 17, 2014
Last Update Posted : June 27, 2014
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Sponsor:
Evoke Pharma
Information provided by (Responsible Party):
Evoke Pharma
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Brief Summary:
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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Gastroparesis Diabetic Gastroparesis Diabetes Diabetes Mellitus Delayed Gastric Emptying | Drug: metoclopramide Drug: Placebo | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 287 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, 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 |
| Study Start Date : | April 2009 |
| Actual Primary Completion Date : | December 2011 |
| Actual Study Completion Date : | December 2011 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
| 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 |
Primary Outcome Measures :
- The Primary Efficacy Endpoint is the Change From Baseline to Week 4 of the Treatment Period in the Modified Gastroparesis Cardinal Symptom Index-Daily Diary (mGCSI-DD) Total Score. [ Time Frame: 4 weeks ]
Change from Baseline to Week 4 of the treatment period in the mGCSI-DD total score in male and female subjects receiving metoclopramide nasal spray versus subjects receiving placebo.
The mGCSI-DD is a patient reported outcome measure of gastroparesis symptom severity composed of 4 individual symptoms (listed below) with each symptom graded on a scale from 0 (none) to 5 (very severe).
- Nausea (feeling sick to your stomach as if you were going to vomit or throw up)
- Early satiety (not able to finish a normal sized meal)
- Bloating (feeling like you need to loosen clothes)
- Upper abdominal pain (above the navel) The mGCSI-DD daily score is a mean of the 4 individual symptom scores. The total score is a mean of the daily scores for the observation period.
A mean change (improvement) of >1 category (for example, moderate to mild or severe to moderate) is considered to be clinically meaningful.
Other Outcome Measures:
- The Pre-specified Endpoint is the Change From Baseline to Week 4 of the Treatment Period in the Modified Gastroparesis Cardinal Symptom Index-Daily Diary (mGCSI-DD) Total Score by Gender. [ Time Frame: 4 weeks ]
Change from Baseline to Week 4 of the treatment period in the mGCSI-DD total score in Female subjects receiving metoclopramide nasal spray versus Female subjects receiving placebo.
The mGCSI-DD is a patient reported outcome measure of gastroparesis symptom severity composed of 4 individual symptoms (listed below) with each symptom graded on a scale from 0 (none) to 5 (very severe).
- Nausea (feeling sick to your stomach as if you were going to vomit or throw up)
- Early satiety (not able to finish a normal sized meal)
- Bloating (feeling like you need to loosen clothes)
- Upper abdominal pain (above the navel) The mGCSI-DD daily score is a mean of the 4 individual symptom scores. The total score is a mean of the daily scores for the observation period.
A mean change (improvement) of >1 category (for example, moderate to mild or severe to moderate) is considered to be clinically meaningful.
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria
- Male subjects and non-pregnant, non-lactating female subjects between the ages of 18 and 75 years (inclusive)
- Willing and able to give written informed consent to participate in the study
- Ability to read and understand English
- Diagnosis of Type 1 or Type 2 diabetes
- Diagnosis of diabetic gastroparesis previously documented
- A mean daily GCSI-DD score of ≥2 and ≤4 for the 7 days prior to the Randomization Visit (Visit 3, Day 0)
- 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, or cervical cap with spermicide), intrauterine device (IUD), or vasectomized partner (6-months minimum)
- 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
- 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
- Gastric bypass and gastric banding, gastric pacemakers, post-surgical causes of gastroparesis and disorders known to be associated with abnormal gastrointestinal motility such as active gastric ulcer, active duodenal ulcer, active severe gastritis, gastric cancer, amyloidosis, neuromuscular diseases (including Parkinson's disease), collagen vascular diseases, alcoholism, uremia, malnutrition, and untreated hypothyroidism
- 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
- History of or physical findings suggestive of tardive dyskinesia
- Currently using and unwilling or unable to stop any medication known to be associated with tardive dyskinesia (See Study Reference Manual) prior to Washout (Visit 2)
- History of allergy to any of the ingredients in the study drug formulation; metoclopramide, citric acid, sodium citrate, benzalkonium chloride, EDTA, or sorbitol
- History of organ transplant, chronic pancreatitis, gross malabsorptive syndromes, celiac disease, or inflammatory bowel disease
- Malignancy (with the exception of basal cell carcinoma of the skin) currently present, initially diagnosed or recurring within 5 years of enrollment
- History of other clinically significant renal, hepatic, neurologic, hematologic, oncologic, pulmonary, psychiatric, cardiovascular or infectious disease, 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
- Have renal dysfunction calculated as creatinine clearance (CrCl) < 40 mL/min at Screening (Visit 1)
- Have a hemoglobin A1c > 12.5% at Screening (Visit 1)
- 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; oral and parenteral formulations of metoclopramide, domperidone, tricyclic antidepressants, macrolide antibiotics, prokinetic agents, cholinergic agents, agents with significant anticholinergic effects, narcotic analgesics, orally administered β agonists, spasmolytics, dopamine agonists, monoamine oxidase inhibitors, herbal supplements, fiber or bulking products, and laxatives
- Use of neurotoxins (e.g., botulinum type A or B) as a treatment for gastroparesis or delayed gastric emptying within 6 months of Screening (Visit 1)
- Clinically significant abnormal finding or a QTc interval >450 milliseconds (msec) on ECGs obtained at Screening (Visit 1) OR pre- or post-dose at Randomization (Visit 3)
- 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 (see Study Reference Manual)
- Female subjects who are trying to conceive, are pregnant, or are lactating
- 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
- History of alcohol or drug abuse within the year prior to the Screening Visit, or current known evidence of substance dependence or abuse
- Participation in a clinical (investigational) trial or receipt of a non-FDA approved therapy within 30 days prior to the Screening Visit (Visit 1) with the exception of domperidone
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00845858
Locations
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Sponsors and Collaborators
Evoke Pharma
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Evoke Pharma |
| ClinicalTrials.gov Identifier: | NCT00845858 |
| Other Study ID Numbers: |
METO-IN-002 |
| First Posted: | February 18, 2009 Key Record Dates |
| Results First Posted: | June 17, 2014 |
| Last Update Posted: | June 27, 2014 |
| Last Verified: | November 2013 |
Keywords provided by Evoke Pharma:
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Gastroparesis Diabetic Gastroparesis Diabetes Diabetes Mellitus Delayed Gastric Emptying |
Additional relevant MeSH terms:
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Gastroparesis Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Stomach Diseases Gastrointestinal Diseases Digestive System Diseases Paralysis Neurologic Manifestations Metoclopramide |
Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Dopamine D2 Receptor Antagonists Dopamine Antagonists Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |