Symptomatic Treatment Of Patients With Neuropathic Pain With LYRICA
NCT00843284
Last updated date
ABOUT THIS STUDY
A Non-Interventional, Post-Marketing Surveillance (NI-PMS) study whose objectives were to
assess the impact of pregabalin on subjects' pain, quality of sleep, and their general
wellbeing, as well as the tolerance and safety of pregabalin in subjects with neuropathic
pain.
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.
Neuropathic Pain
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
- Clinical diagnosis of neuropathic pain and inclusion according to the current Summary of Product Characteristics.
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- The patients were excluded according to the current Summary of Product
Characteristics.
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Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title | Symptomatic Treatment Of Patients With Neuropathic Pain With LYRICA | |||
| Official Title | Assessing the Treatment of Patients With Neuropathic Pain Using LYRICA; A Non Interventional Post-marketing Study (NI-PMS) | |||
| Brief Summary | A Non-Interventional, Post-Marketing Surveillance (NI-PMS) study whose objectives were to assess the impact of pregabalin on subjects' pain, quality of sleep, and their general wellbeing, as well as the tolerance and safety of pregabalin in subjects with neuropathic pain. | |||
| Detailed Description | A non-interventional study of patients diagnosed with neuropathic pain administered pregabalin and followed up for 8 weeks | |||
| Study Type | Observational | |||
| Study Design | Observational Model: Other Time Perspective: Prospective | |||
| Target Follow-Up Duration | Not Provided | |||
| Biospecimen | Not Provided | |||
| Sampling Method | Non-Probability Sample | |||
| Study Population | Patients with neuropathic pain | |||
| Condition | Neuropathic Pain | |||
| Intervention | Drug: Pregabalin
Capsules, 150 - 600 mg/day, 2-3 times/day, 8 weeks | |||
| Study Groups/Cohorts | Patients with neuropathic pain
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 | Completed | |||
| Actual Enrollment | 691 | |||
| Original Actual Enrollment | 700 | |||
| Actual Study Completion Date | March 2008 | |||
| Actual Primary Completion Date | March 2008 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender |
| |||
| Ages | 18 Years and older (Adult, Older Adult) | |||
| Accepts Healthy Volunteers | No | |||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries | Not Provided | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number | NCT00843284 | |||
| Other Study ID Numbers | A0081139 ATLAS | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement | Not Provided | |||
| Responsible Party | Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. ) | |||
| Study Sponsor | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | |||
| Collaborators | Not Provided | |||
| Investigators |
| |||
| PRS Account | Pfizer | |||
| Verification Date | October 2009 | |||