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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01256593
First Posted: December 8, 2010
Last Update Posted: September 20, 2017
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.
Information provided by (Responsible Party):
Pfizer
  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
Neuralgia Drug: Pregabalin (Lyrica) capsule

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Drug Use Investigation Of Lyrica(Regulatory Post Marketing Commitment Plan)

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 ]
    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.


Estimated Enrollment: 4000
Actual Study Start Date: February 2011
Study Completion Date: July 2017
Primary Completion Date: July 2017 (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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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®.
  Contacts and Locations
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
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01256593     History of Changes
Other Study ID Numbers: A0081261
First Submitted: December 7, 2010
First Posted: December 8, 2010
Last Update Posted: September 20, 2017
Last Verified: September 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