Safety And Efficacy Of Lyrica (Regulatory Post Marketing Commitment Plan) (RAINBOW)
This study is enrolling participants by invitation only.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01256593
First received: December 7, 2010
Last updated: May 30, 2013
Last verified: May 2013
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Purpose
The objective of this Investigation is to evaluate the safety and efficacy of Lyrica in medical practice. Also, occurrence of unknown and known adverse drug reactions (ADRs) in subjects treated with Lyrica will be monitored during the survey period, and whether an additional treatment outcome investigation and/or a post-marketing clinical study is required in the future will be determined.
| Condition | Intervention | Phase |
|---|---|---|
|
Neuralgia |
Drug: Pregabalin (Lyrica) capsule |
Phase 4 |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Research For Anti-Neuropathic Pain Treatment In General Practice, Both Efficacy And Safety Of Relief The Pain On Worsening By Lyrica |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Change in Clinical Global Impression of Clinical Condition (CGI-C) From Baseline at Month X [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 3700 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | July 2018 |
| Estimated Primary Completion Date: | July 2018 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Pregabalin (Lyrica) capsule
Patients administered "Pregabalin capsule".
|
Drug: Pregabalin (Lyrica) capsule
Lyrica® Capsules depending on the investigator prescription. Frequency and duration are according to Package Insert as follows. "The usual adult dosage for oral use begins at 150 mg/day of pregabalin in twice daily, and should be gradually increased to 300 mg/day over 1 week or more and should be orally administered twice daily. Dosage should be adjusted, depending on age or symptoms. However, the daily maximum dose should not be beyond 600 mg, and should be orally administered twice daily".
Other Name: Lyrica® Capsules 25 mg, Lyrica® Capsules 75 mg, Lyrica® Capsules 150 mg
|
Detailed Description:
All the patients whom an investigator prescribes the first Lyrica® should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
The patients whom an investigator involving A0081261 prescribes the Lyrica capsule.
Criteria
Inclusion Criteria:
- Patients need to be administered Lyrica® in order to be enrolled in the surveillance.
Exclusion Criteria:
- Patients not administered Lyrica®.
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01256593 History of Changes |
| Other Study ID Numbers: | A0081261 |
| Study First Received: | December 7, 2010 |
| Last Updated: | May 30, 2013 |
| Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
Keywords provided by Pfizer:
|
Lyrica Regulatory Post Marketing Commitment Plan Safety Neuropathic Pain Post Marketing Surveillance |
Additional relevant MeSH terms:
|
Neuralgia Pain Neurologic Manifestations Nervous System Diseases Peripheral Nervous System Diseases Neuromuscular Diseases Signs and Symptoms Pregabalin |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anticonvulsants |
ClinicalTrials.gov processed this record on June 17, 2013