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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00861809 |
The purpose of this study is to assess the pharmacodynamic effects (gastric emptying), safety, tolerability, and pharmacokinetics of single doses of GSK962040 in Type I diabetic patients with gastroparesis.
Condition | Intervention | Phase |
---|---|---|
Diabetic Gastroparesis Gastroparesis |
Drug: GSK962040 or Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Crossover Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | A Multicenter, Double-Blind, Randomized Placebo-Controlled Phase II Study to Evaluate the Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of Single Doses of the Oral Motilin Receptor Agonist GSK962040, in Type I Diabetic Male and Female Patients With Gastroparesis |
Estimated Enrollment: | 18 |
Study Start Date: | June 2009 |
Estimated Study Completion Date: | November 2009 |
Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Cohort 1: Experimental |
Drug: GSK962040 or Placebo
Initial dose levels to be evaluated include 25, 50, and 125 mg. However, analysis of safety, PK, and PD data will be performed during the conduct of this study to ensure adequate sample size and that the dose levels selected are appropriate. The dose levels to be tested will not be below a minimum of 10 mg and will not exceed a maximum dose level of 150 mg. All patients will receive placebo and 2 of the 3 possible doses of GSK962040 in a randomized, double blind, placebo controlled, incomplete block, three period crossover design. |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Patients with a history of hypothyroidism on a stable dose of thyroid replacement therapy are eligible to participate in the study).
Contact: US GSK Clinical Trials Call Center | 877-379-3718 |
Belgium | |
GSK Investigational Site | |
Leuven, Belgium, 3000 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 111809, MOT111809 |
Study First Received: | February 26, 2009 |
Last Updated: | June 18, 2009 |
ClinicalTrials.gov Identifier: | NCT00861809 History of Changes |
Health Authority: | Belgium: Agence Fédérale des Médicaments et des Produits de la Santé; Belgium: Institutional Review Board; Sweden: Läkemedelsverket; Sweden: Medical Products Agency |
single dose tolerability pharmacokinetics gut motility pharmacodynamics |
gastric emtpying Type I Diabetes Mellitus patients 13C octanoic acid breath test phase II |
Paralysis Signs and Symptoms Digestive System Diseases Stomach Diseases Diabetes Mellitus, Type 1 |
Gastrointestinal Diseases Diabetes Mellitus Neurologic Manifestations Diabetes Mellitus Type 1 Gastroparesis |
Paralysis Signs and Symptoms Digestive System Diseases Stomach Diseases |
Gastrointestinal Diseases Neurologic Manifestations Gastroparesis |