- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01279850
Safety And Efficacy In Long Term Use Of Lyrica (Regulatory Post Marketing Commitment Plan) (RAINBOW-L)
September 26, 2023 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
SPECIAL INVESTIGATION OF LONG TERM USE OF LYRICA(REGULATORY POST MARKETING COMMITMENT PLAN)
The objective of this investigation is to evaluate the safety and efficacy of long term use with 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Patients who fulfill criteria below:
- Patients who have previously enrolled in A0081261.
- Patients who have been administered Lyrica for more than 52 weeks.
Study Type
Observational
Enrollment (Actual)
891
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 second and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
The patients whom an investigator involving A0081262 prescribes the Lyrica capsule.
And the patients who are administered Lyrica for over 52 weeks (MAX 104 weeks).
Description
Inclusion Criteria:
- Patients need to be administered by Lyrica for over 52 weeks in order to be enrolled in the surveillance.
Exclusion Criteria:
- Patients not administered Lyrica.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Pregabalin (Lyrica) capsule
Patients administered "Pregabalin 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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Adverse Drug Reaction
Time Frame: From Week 1 to Week 104 at maximum
|
An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules.
Relatedness to LYRICA Capsules was assessed by the physician.
|
From Week 1 to Week 104 at maximum
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Serious Adverse Drug Reaction
Time Frame: From Week 1 to Week 104 at maximum
|
An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules.
A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly.
Relatedness to LYRICA Capsules was assessed by the physician.
|
From Week 1 to Week 104 at maximum
|
Percentage of Participants With Adverse Drug Reaction Unexpected From Japanese Package Insert
Time Frame: From Week 1 to Week 104 at maximum
|
An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules.
Expectedness of the adverse event was determined according to the Japanese package insert.
Relatedness to LYRICA Capsules was assessed by the physician.
|
From Week 1 to Week 104 at maximum
|
Number of Participants With Adverse Drug Reactions Related to Peripheral Edema or Other Edema-related Events
Time Frame: From Week 1 to Week 104 at maximum
|
An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules.
Relatedness to LYRICA Capsules was assessed by the physician.
Occurrence of ADRs related to peripheral edema or other edema-related events was evaluated.
|
From Week 1 to Week 104 at maximum
|
Number of Participants With Adverse Drug Reactions Related to Dizziness, Somnolence, Loss of Consciousness, Syncope, and Potential for Accidental Injury
Time Frame: From Week 1 to Week 104 at maximum
|
An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules.
Relatedness to LYRICA Capsules was assessed by the physician.
Occurrence of ADRs related to dizziness, somnolence, loss of consciousness, syncope, and potential for accidental injury was evaluated.
|
From Week 1 to Week 104 at maximum
|
Number of Participants With Adverse Drug Reactions Related to Vision-related Events
Time Frame: From Week 1 to Week 104 at maximum
|
An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules.
Relatedness to LYRICA Capsules was assessed by the physician.
Occurrence of ADRs related to vision-related events was evaluated.
|
From Week 1 to Week 104 at maximum
|
Clinical Effectiveness Rate
Time Frame: At Week 104
|
Clinical effectiveness of LYRICA Capsules was determined by the physician based on the following categories: (1) effective, (2) ineffective, or (3) impossible to judge at Week 104 of the treatment.
Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of the analysis population, was presented along with the corresponding 2-sided 95% CI.
|
At Week 104
|
Change From Baseline in Participant-rated Pain Score at Week 104
Time Frame: Baseline and at Week 104
|
The pain experienced at Week 104 during the past 24 hours was rated by participants at the time of getting up in the morning on an 11-grade scale, ranging from 0 (no pain) to 10 (the most severe pain possible).
Mean change from baseline in participant-rated pain score at Week 104 was presented along with standard deviation.
|
Baseline and at Week 104
|
Change From Baseline in Participant-rated Sleep Interference Score at Week 104
Time Frame: Baseline and at Week 104
|
The sleep interference (inability to sleep because of pain) experienced at Week 104 during the past 24 hours was rated by participants at the time of getting up in the morning on an 11-grade scale, ranging from 0 (no disturbance) to 10 (totally unable to sleep because of pain).
Mean change from baseline in participant-rated sleep interference score at Week 104 was presented along with standard deviation.
|
Baseline and at Week 104
|
Patient's Impression (PGIC) at Week 104
Time Frame: At Week 104
|
The patient's impression (patient global impression of change [PGIC]) at Week 104, as compared to the baseline condition (including the first day of treatment), was rated by participants on a 7-grade scale.
|
At Week 104
|
Physician's Impression (CGIC) at Week 104
Time Frame: At Week 104
|
The physician's impression (clinical global impression of change [CGIC]) at Week 104, as compared to the baseline condition (including the first day of treatment), was rated by the physician on a 7-grade scale.
|
At Week 104
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2011
Primary Completion (Actual)
July 1, 2017
Study Completion (Actual)
July 1, 2017
Study Registration Dates
First Submitted
January 18, 2011
First Submitted That Met QC Criteria
January 18, 2011
First Posted (Estimated)
January 19, 2011
Study Record Updates
Last Update Posted (Estimated)
October 9, 2023
Last Update Submitted That Met QC Criteria
September 26, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Pain
- Neurologic Manifestations
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Neuralgia
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Membrane Transport Modulators
- Anti-Anxiety Agents
- Anticonvulsants
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Pregabalin
Other Study ID Numbers
- A0081262
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g.
protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions.
Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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