An Open Label Pharmacokinetic Study Of Gabapentin In Japanese Subjects With Renal Impairment Including Hemodialysis
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Purpose
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 |
|---|---|---|
|
PK Properties Of Gabapentin In Subjects With Impaired Renal Function |
Drug: Gabapentin |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open Label Pharmacokinetic Study Of Gabapentin In Japanese Subjects With Renal Impairment Including Hemodialysis |
- Pharmacokinetics [ Time Frame: dec 2008 ] [ Designated as safety issue: No ]
- There were no secondary outcomes measures for this study [ Time Frame: dec 2008 ] [ Designated as safety issue: No ]
| 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 |
|---|---|
| Experimental: 1 |
Drug: Gabapentin
CLcr: 29-30 mL/min
|
| Experimental: 2 |
Drug: Gabapentin
CLcr: 29-15 mL/min
|
| Experimental: 3 |
Drug: Gabapentin
CLcr:14-5 mL/min
|
| Experimental: 4 |
Drug: Gabapentin
Hemodialysis
|
Detailed Description:
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".
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- The subjects whose creatinine clearance is 5-59 mL/min, or hemodialysis patients.
- The hemodialysis patients who enter this study is required hemodialysis for at least six weeks (the frequency is three times per week)
Exclusion Criteria:
- Renal allograft recipients
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trials Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT00584779 History of Changes |
| Other Study ID Numbers: | A9451160 |
| Study First Received: | December 21, 2007 |
| Last Updated: | March 11, 2009 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by Pfizer:
|
Gabapentin Pharmacokinetics, renal impairment |
Additional relevant MeSH terms:
|
Renal Insufficiency Kidney Diseases Urologic Diseases Gabapentin Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anticonvulsants Antiparkinson Agents |
Anti-Dyskinesia Agents Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Antimanic Agents |
ClinicalTrials.gov processed this record on May 22, 2013