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View Clinical Trial (Medical Research Study)
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Efficacy and Safety of Metoclopramide Nasal Spray Solution in Diabetic Patients With Gastroparesis - NCT00845858-91361 (Clinical Trial 272669)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy272669.aspx
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| City: |
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Westlake Village |
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State:
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CA |
| Zip Code: |
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91361 |
| Conditions: |
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Gastroparesis - Diabetic Gastroparesis - Diabetes - Diabetes Mellitus - Delayed Gastric Emptying |
| Purpose: |
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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.
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| Study summary: |
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| Criteria: |
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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 |
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| Study is available at: |
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Westlake Medical Research
Westlake Village, CA 91361
United States |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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