A Long-Term Study To Evaluate Safety And Efficacy Of Pregabalin For Postherpetic Neuralgia
NCT00424372
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- Patients who completed the 13-week treatment of postherpetic neuralgia in Study A0081120.
- Patients must be able to understand and cooperate with study procedures and have signed a written informed consent prior to entering the study.
- Patients who experienced serious adverse events in the preceding study (A0081120) that
were determined by the investigator or the study sponsor to be causally related to the
study medication.
- Patients exhibiting treatment non-compliance in the preceding study (A0081120)
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Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | A Long-Term Study To Evaluate Safety And Efficacy Of Pregabalin For Postherpetic Neuralgia | |||
Official Title ICMJE | A Long-Term Study To Evaluate Safety And Efficacy Of Pregabalin In The Treatment Of Postherpetic Neuralgia | |||
Brief Summary | To evaluate the safety of the long-term use of pregabalin. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Neuralgia, Postherpetic | |||
Intervention ICMJE | Drug: pregabalin
Dosage: 150-600 mg/day (75-300 mg bid), oral administration, Treatment duration: 52 weeks | |||
Study Arms ICMJE | Experimental: pregabalin
Intervention: Drug: pregabalin | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 126 | |||
Original Enrollment ICMJE | 150 | |||
Actual Study Completion Date ICMJE | August 2008 | |||
Actual Primary Completion Date | August 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Japan | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00424372 | |||
Other Study ID Numbers ICMJE | A0081121 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Director, Clinical Trials Disclosure Group, Pfizer, Inc. | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | October 2009 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |