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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00584779 |
To confirm the pharmacokinetics following administration of gabapentin to Japanese subjects with renal impairment, compare the results to Western study results and confirm the adaptive possibility of dose adjustment in US package insert to Japanese.
Condition | Intervention | Phase |
---|---|---|
Renal Impairment |
Drug: Gabapentin |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Parallel Assignment, Pharmacokinetics Study |
Official Title: | An Open Label Pharmacokinetic Study Of Gabapentin In Japanese Subjects With Renal Impairment Including Hemodialysis |
Enrollment: | 8 |
Study Start Date: | October 2007 |
Study Completion Date: | December 2007 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: Gabapentin
CLcr: 29-30 mL/min
|
2: Experimental |
Drug: Gabapentin
CLcr: 29-15 mL/min
|
3: Experimental |
Drug: Gabapentin
CLcr:14-5 mL/min
|
4: Experimental |
Drug: Gabapentin
Hemodialysis
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The study was terminated on September 30, 2008 at the current study site due to reported adverse events in the study subjects (n=8). While the adverse events reported were generally consistent with the known profile of gabapentin, it was decided that the study should continue at a different study site. The pharmacokinetics of gabapentin in the subjects with renal impairment will be evaluated in a separate study with a different study number at a different site. The study will be entitled: "The Pharmacokinetic Study of Gabapentin in Japanese Epileptic Subjects with Renal Impairment".
Ages Eligible for Study: | 20 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trials Disclosure Group ) |
Study ID Numbers: | A9451160 |
Study First Received: | December 21, 2007 |
Last Updated: | October 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00584779 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Gabapentin Pharmacokinetics |
Excitatory Amino Acids Calcium, Dietary Gabapentin |
Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Antiparkinson Agents Calcium Channel Blockers Excitatory Amino Acid Agents Cardiovascular Agents |
Antimanic Agents Pharmacologic Actions Membrane Transport Modulators Sensory System Agents Therapeutic Uses Anti-Anxiety Agents Analgesics Peripheral Nervous System Agents Central Nervous System Agents Anticonvulsants Excitatory Amino Acid Antagonists |