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Safety And Efficacy Of Lyrica (Regulatory Post Marketing Commitment Plan) (RAINBOW)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01256593
Recruitment Status : Completed
First Posted : December 8, 2010
Last Update Posted : November 29, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
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 or disease Intervention/treatment
Neuralgia Drug: Pregabalin (Lyrica) capsule

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.

Study Type : Observational
Actual Enrollment : 3827 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Drug Use Investigation Of Lyrica(Regulatory Post Marketing Commitment Plan)
Actual Study Start Date : February 5, 2011
Primary Completion Date : July 31, 2017
Study Completion Date : July 31, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Pregabalin
U.S. FDA Resources

Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. Change in Clinical Global Impression of Clinical Condition (CGI-C) From Baseline at Month X [ Time Frame: 13 weeks ]
    The CGI-C scale measures a physician's global impression of a participant's clinical condition at final visit in terms of change relative to the start of treatment (CGI-C). At final visit, the participants CGI-C will be categorized into a three point scale as: improvement: CGI response of very much improved, much improved or minimally improved; no change: CGI response of no change; worsening: CGI response of very much worse, much worse or minimally worse.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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®.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01256593


Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01256593     History of Changes
Other Study ID Numbers: A0081261
First Posted: December 8, 2010    Key Record Dates
Last Update Posted: November 29, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs