A Phase III Open-Label Study Of Gabapentin As Adjunctive Therapy In Japanese Pediatric Patients With Partial Seizures
Overview[ - collapse ][ - ]
| Purpose | Examine the efficacy, safety and pharmacokinetics of gabapentin as adjunctive therapy in Japanese pediatric patients with partial seizures |
|---|---|
| Condition | Epilepsies, Partial |
| Intervention | Drug: gabapentin |
| Phase | Phase 3 |
| Sponsor | Pfizer |
| Responsible Party | Pfizer |
| ClinicalTrials.gov Identifier | NCT00603473 |
| First Received | January 16, 2008 |
| Last Updated | January 24, 2011 |
| Last verified | January 2011 |
Tracking Information[ + expand ][ + ]
| First Received Date | January 16, 2008 |
|---|---|
| Last Updated Date | January 24, 2011 |
| Start Date | January 2008 |
| Estimated Primary Completion Date | December 2009 |
| Current Primary Outcome Measures | Response Ratio of Gabapentin in Japanese Pediatric Patients With Partial Seizures [Time Frame: 12 weeks] [Designated as safety issue: No]The Response Ratio calculated by the following equation was assessed as the primary endpoint: R Ratio = (T−B) / (T+B) where T is seizure frequency per 28 days (i.e., the number of seizures per 28 days) calculated from the total number of seizures for the 12-week treatment period, and B is seizure frequency per 28 days (i.e., the number of seizures per 28 days) calculated from the total number of seizures for the 6-week baseline period. |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | A Phase III Open-Label Study Of Gabapentin As Adjunctive Therapy In Japanese Pediatric Patients With Partial Seizures |
|---|---|
| Official Title | An Open-Label, Multicenter Study Evaluating, The Efficacy, Safety And Pharmacokinetics Of Gabapentin As Adjunctive Therapy In Pediatric Patients With Partial Seizures When Other Antiepileptics Do Not Provide Satisfactory Effects |
| Brief Summary | Examine the efficacy, safety and pharmacokinetics of gabapentin as adjunctive therapy in Japanese pediatric patients with partial seizures |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 3 |
| Study Design | Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Epilepsies, Partial |
| Intervention | Drug: gabapentin Orally administered gabapentin |
| Study Arm (s) | Experimental: gabapentin |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 92 |
| Estimated Completion Date | December 2009 |
| Estimated Primary Completion Date | December 2009 |
| Eligibility Criteria | Inclusion Criteria: - Japanese male or females, ages 3-15 years old at acquisition of informed consent, 15 years old or less at the baseline visit - Seizures are classified as simple partial, complex partial or partial becoming secondarily generalized (defined according to the International League Against Epilepsy) - Have not been able to achieve adequate seizure control with antiepileptic drugs Exclusion Criteria: - Seizures related to drugs or acute medical illness - History of any serious medical or psychiatric disorder - Diagnosis or history of a structural CNS lesion or an encephalopathy shown to be progressive |
| Gender | Both |
| Ages | 3 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Japan |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00603473 |
|---|---|
| Other Study ID Numbers | A9451162 |
| Has Data Monitoring Committee | No |
| Information Provided By | Pfizer |
| Study Sponsor | Pfizer |
| Collaborators | Not Provided |
| Investigators | Study Director: Pfizer CT.gov Call Center Pfizer |
| Verification Date | January 2011 |
Locations[ + expand ][ + ]
| Pfizer Investigational Site | Obu-shi,Morioka-machi, Aichi, Japan |
|---|---|
| Pfizer Investigational Site | Jonan-ku, Fukuoka, Japan |
| Pfizer Investigational Site | Sapporo, Hokkaido, Japan |
| Pfizer Investigational Site | Kobe, Hyogo, Japan |
| Pfizer Investigational Site | Suma-Ku, Kobe, Hyogo, Japan |
| Pfizer Investigational Site | Kanazawa, Ishikawa, Japan |
| Pfizer Investigational Site | Zentsuuji, Kagawa, Japan |
| Pfizer Investigational Site | Yokohama, Kanagawa Pref., Japan |
| Pfizer Investigational Site | Sendai-shi, Miyagi-ken, Japan |
| Pfizer Investigational Site | Showa-Ku, Nagoya, Japan |
| Pfizer Investigational Site | Niigata-shi, Niigata, Japan |
| Pfizer Investigational Site | Kurashiki-City, Okayama Pref., Japan |
| Pfizer Investigational Site | Okayama-shi, Okayama, Japan |
| Pfizer Investigational Site | Izumi-shi, Osaka, Japan |
| Pfizer Investigational Site | Miyakojima-ku, Osaka, Japan |
| Pfizer Investigational Site | Suita, Osaka, Japan |
| Pfizer Investigational Site | Higashimatsuyama, Saitama, Japan |
| Pfizer Investigational Site | Shizuoka-shi, Shizuoka, Japan |
| Pfizer Investigational Site | Kiyose-shi, Tokyo, Japan |
| Pfizer Investigational Site | Kodaira, Tokyo, Japan |
| Pfizer Investigational Site | Setagaya-ku, Tokyo, Japan |
| Pfizer Investigational Site | Shinjuku-ku, Tokyo, Japan |
| Pfizer Investigational Site | Hiroshima, Japan |
| Pfizer Investigational Site | Saitama, Japan |
| Pfizer Investigational Site | Yamagata, Japan |
| Pfizer Investigational Site | Yamanashi, Japan |