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

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ClinicalTrials.gov Identifier: NCT01256593
Recruitment Status : Completed
First Posted : December 8, 2010
Results First Posted : May 7, 2019
Last Update Posted : May 7, 2019
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.

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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 2011
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Pregabalin

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. Percentage of Participants With Adverse Drug Reaction [ Time Frame: 13 weeks 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.


Secondary Outcome Measures :
  1. Percentage of Participants With Serious Adverse Drug Reaction [ Time Frame: 13 weeks 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.

  2. The Percentage of Participants With Adverse Drug Reaction Unexpected From Japanese Package Insert [ Time Frame: 13 weeks 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.

  3. Number of Participants With Adverse Drug Reactions Related to Peripheral Edema or Other Edema-related Events [ Time Frame: 13 weeks 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.

  4. Number of Participants With Adverse Drug Reactions Related to Dizziness, Somnolence, Loss of Consciousness, Syncope, and Potential for Accidental Injury [ Time Frame: 13 weeks 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.

  5. Number of Participants With Adverse Drug Reactions Related to Vision-related Events [ Time Frame: 13 weeks 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.

  6. Clinical Effectiveness Rate [ Time Frame: At Week 13 ]
    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 13 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. For the participants who completed or discontinued the treatment before Week 13, the data at the time of the completion or discontinuation was used for the analysis.

  7. Change From Baseline in Participant-rated Pain Score at Week 13 [ Time Frame: Baseline and at Week 13 ]
    The pain experienced at Week 13 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 13 was presented along with standard deviation. For the participants who completed or discontinued the treatment before Week 13, the data at the time of the completion or discontinuation was used for the analysis.

  8. Change From Baseline in Participant-rated Sleep Interference Score at Week 13 [ Time Frame: Baseline and at Week 13 ]
    The sleep interference (inability to sleep because of pain) experienced at Week 13 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 13 was presented along with standard deviation. For the participants who completed or discontinued the treatment before Week 13, the data at the time of the completion or discontinuation was used for the analysis.

  9. Patient's Impression (PGIC) at Week 13 [ Time Frame: At Week 13 ]
    The patient's impression (patient global impression of change [PGIC]) at Week 13, as compared to the baseline condition (including the first day of treatment), was rated by participants on a 7-grade scale. For the participants who completed or discontinued the treatment before Week 13, the data at the time of the completion or discontinuation was used for the analysis.

  10. Physician's Impression (CGIC) at Week 13 [ Time Frame: At Week 13 ]
    The physician's impression (clinical global impression of change [CGIC]) at Week 13, as compared to the baseline condition (including the first day of treatment), was rated by the physician on a 7-grade scale. For the participants who completed or discontinued the treatment before Week 13, the data at the time of the completion or discontinuation was used for the analysis.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
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
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Study Director: Pfizer CT.gov Call Center Pfizer
  Study Documents (Full-Text)

Documents provided by Pfizer:
Study Protocol  [PDF] April 8, 2013
Statistical Analysis Plan  [PDF] March 9, 2018


Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01256593     History of Changes
Other Study ID Numbers: A0081261
First Posted: December 8, 2010    Key Record Dates
Results First Posted: May 7, 2019
Last Update Posted: May 7, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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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:
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Neuralgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
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
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs