A Post Marketing Surveillance Study On Pregabalin (Lyrica) On Efficacy, Safety And Tolerability Of Pregabalin
NCT00892008
Last updated date
ABOUT THIS STUDY
This study is being conducted as a regulatory requirement post initial marketing
authorization. This is primarily a safety study. This was an open label study and patients
were enrolled once the decision to prescribe the medication was made by the Investigator.
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
- Male or female, 18 years old and above diagnosed with neuropathic pain.
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- Patients that are pregnant and lactating; and patients with known hypersensitivity to
pregabalin or its related components.
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
Neuropathic PainA Study to Assess the Efficacy, Safety and Tolerability of Pregabalin in Patients With Symptoms of Neuropathic Pain
NCT00301223
- Beijing,
- Cheng Du Si Chaun,
- Guang Zhou,
- Nan Jing, Jiang Su,
- Qing Dao Shan Dong,
- Shang Hai,
- Shanghai,
- Tian Jin,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Neuropathic PainEfficacy Study Measuring the Impact of Pregabalin on Peripheral Neuropathic Pain.
NCT00219544
- Calgary, Alberta
- Calgary, Alberta
- Calgary, Alberta
- Edmonton, Alberta
- Edmonton, Alberta
- Red Deer, Alberta
- Kelowna, British Columbia
- Vancouver, British Columbia
- Vancouver, British Columbia
- Winnipeg, Manitoba
- Winnipeg, Manitoba
- Winnipeg, Manitoba
- Halifax, Nova Scotia
- Kingston, Ontario
- London, Ontario
- Port Hope, Ontario
- Toronto, Ontario
- Charlottetown, Prince Edward Island
- Granby, Quebec
- Laval, Quebec
- Laval, Quebec
- Levis, Quebec
- Mirabel, Quebec
- Montreal, Quebec
- Montreal, Quebec
- Montreal, Quebec
- Sherbrooke, Quebec
- Sherbrook, Quebec
- Ste-Foy, Quebec
- Saskatoon, Saskatchewan
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Neuropathic PainA Post Marketing Surveillance Study On Pregabalin (Lyrica) On Efficacy, Safety And Tolerability Of Pregabalin
NCT00892008
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Neuropathic PainTo Evaluate Long-Term Safety and Efficacy of Pregabalin in the Treatment of Neuropathic Pain After Spinal Cord Injury.
NCT00141375
- Little Bay, New South Wales
- St. Leonards, New South Wales
- Warrawong, New South Wales
- Woolloongabba, Queensland
- Heidelberg, Victoria
- Shenton Park, Western Australia
- NSW,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title | A Post Marketing Surveillance Study On Pregabalin (Lyrica) On Efficacy, Safety And Tolerability Of Pregabalin | |||
| Official Title | Pregabalin (Lyrica) Action In Neuropathic Pain Syndrome (PAINS): A Post Marketing Surveillance Study On Efficacy, Safety And Tolerability Of Pregabalin | |||
| Brief Summary | This study is being conducted as a regulatory requirement post initial marketing authorization. This is primarily a safety study. This was an open label study and patients were enrolled once the decision to prescribe the medication was made by the Investigator. | |||
| Detailed Description | Not Provided | |||
| Study Type | Observational | |||
| Study Design | Observational Model: Cohort Time Perspective: Prospective | |||
| Target Follow-Up Duration | Not Provided | |||
| Biospecimen | Not Provided | |||
| Sampling Method | Non-Probability Sample | |||
| Study Population | Male or female, 18 years and above diagnosed with neuropathic pain. | |||
| Condition | Neuropathic Pain | |||
| Intervention | Drug: Pregabalin
Pregabalin 75-150 mg BID for at least 2 weeks. Other Name: Lyrica | |||
| Study Groups/Cohorts | Open-Label
This study was open-label with only one treatment group. Pregabalin was prescribed in accordance with usual clinical practice. 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 | 2278 | |||
| Original Actual Enrollment | 3000 | |||
| Actual Study Completion Date | August 2008 | |||
| Actual Primary Completion Date | August 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 | NCT00892008 | |||
| Other Study ID Numbers | A0081094 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement | Not Provided | |||
| Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
| Study Sponsor | Pfizer | |||
| Collaborators | Not Provided | |||
| Investigators |
| |||
| PRS Account | Pfizer | |||
| Verification Date | January 2010 | |||