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

Completed

• Conditions: Neuralgia
• Interventions: Drug: Pregabalin (Lyrica) capsule

• Registration Number: NCT01256593
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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.

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 Timeline

• Study First Submitted: 2010-12-07
• Study First Submitted QC: 2010-12-07
• Study First Posted: 2010-12-08
• Study Start: 2011-02-05
• Primary Completion: 2017-07-31
• Study Completion: 2017-07-31
• Results First Submitted: 2018-07-23
• Results First Submitted QC: 2019-01-30
• Results First Posted: 2019-05-07
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-21
• Last Update Posted: 2023-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3827

Inclusion Criteria

• Patients need to be administered Lyrica® in order to be enrolled in the surveillance.

Exclusion Criteria

• Patients not administered Lyrica®.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pregabalin (Lyrica) capsule	Pregabalin (Lyrica) capsule	Patients administered "Pregabalin capsule".

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Adverse Drug Reaction	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

Name	Time	Method
Percentage of Participants With Serious Adverse Drug Reaction	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.
The Percentage of Participants With Adverse Drug Reaction Unexpected From Japanese Package Insert	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.
Number of Participants With Adverse Drug Reactions Related to Peripheral Edema or Other Edema-related Events	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.
Number of Participants With Adverse Drug Reactions Related to Dizziness, Somnolence, Loss of Consciousness, Syncope, and Potential for Accidental Injury	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.
Number of Participants With Adverse Drug Reactions Related to Vision-related Events	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.
Clinical Effectiveness Rate	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.
Change From Baseline in Participant-rated Pain Score at Week 13	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.
Physician's Impression (CGIC) at Week 13	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.
Patient's Impression (PGIC) at Week 13	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.
Change From Baseline in Participant-rated Sleep Interference Score at Week 13	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.