A Study to Evaluate the Efficacy and Safety of Pregabalin (Lyrica) for the Treatment of Nerve Pain
NCT00631943
Last updated date
ABOUT THIS STUDY
The purpose of this study is to evaluate the efficacy and safety of Lyrica in Indian patients
with nerve pain
Study Location
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Neuralgia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- Peripheral neuropathic pain
- Score of at least 40 mm on the VAS of the SF-MPQ at screening and baseline
- Completion of at least 4 daily pain diary entries with an average daily pain score of at least 4 over the 7 days prior to baseline
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
(none)
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Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | A Study to Evaluate the Efficacy and Safety of Pregabalin (Lyrica) for the Treatment of Nerve Pain | |||
| Official Title ICMJE | An Open Label, Non-comparative, Multicentre Study to Evaluate the Efficacy and Tolerability of Pregabalin in Peripheral Neuropathic Pain | |||
| Brief Summary | The purpose of this study is to evaluate the efficacy and safety of Lyrica in Indian patients with nerve pain | |||
| 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 | |||
| Intervention ICMJE | Drug: Pregabalin (Lyrica)
Oral pregabalin (Lyrica) capsules, initial dose of 75 mg twice daily, which could be increased to 300 mg twice daily at the discretion of the investigator. Patients were treated for up to 21 days. | |||
| Study Arms ICMJE | Experimental: 1
Intervention: Drug: Pregabalin (Lyrica) | |||
| 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 | 112 | |||
| Original Estimated Enrollment ICMJE | 111 | |||
| Actual Study Completion Date ICMJE | March 2005 | |||
| Primary Completion Date | Not Provided | |||
| Eligibility Criteria ICMJE | Inclusion criteria:
Exclusion criteria: (none) | |||
| 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 | India | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00631943 | |||
| Other Study ID Numbers ICMJE | A0081068 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. ) | |||
| Study Sponsor ICMJE | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Pfizer | |||
| Verification Date | April 2011 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||