Lyrica (Pregabalin) Korean Post Marketing Surveillance Study

NCT01220180 | Completed Results

• 1 other identifier: A0081138
• Study Type: observational
• Target: 4,175
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study collects post-marketing safety and efficacy surveillance data in real world clinical use of pregabalin for its approved indications in Korea.

Conditions

Epilepsy; Neuropathic Pain; Fibromyalgia; Post-market Surveillance

Keywords

epilepsy; neuropathic pain; fibromyalgia; post-market surveillance; prospective observational

Outcome Measures

Primary Outcomes (8)

• Percentage of Participants Achieving 28 Days Seizure Free Period in Intent-to Treat (ITT) Population

  Participants were regarded as seizure-free if no seizures (partial or other) were reported for the participant during the period of 28 days in the study.

  Baseline through Week 12

• Percentage of Participants Achieving 28 Days Seizure Free Period in Per Protocol (PP) Population

  Participants were regarded as seizure-free if no seizures (partial or other) were reported for the participant during the period of 28 days in the study.

  Baseline through Week 12

• Percentage of Participants With Improvement in Seizure Frequency in ITT Population

  Percentage of participants with improvement in seizure frequency of greater than or equal to 75%; greater than or equal to 50% to 74%; 0% to 49% were considered.

  Baseline through Week 12

• Percentage of Participants With Improvement in Seizure Frequency in PP Population

  Percentage of participants with improvement in seizure frequency of greater than or equal to 75%; greater than or equal to 50% to 74%; 0% to 49% were considered.

  Baseline through Week 12

• Change From Baseline in Daily Pain Score for NeP in ITT Population at Week 6

  Daily Pain Rating Score (DPRS): participant rated 11-point Likert scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain.

  Baseline and Week 6

• Change From Baseline in Daily Pain Score for NeP in PP Population at Week 6

  DPRS: participant rated 11-point Likert scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain.

  Baseline and Week 6

• Change From Baseline in Daily Pain Score for Fibromyalgia in ITT Population at Week 6

  DPRS: participant rated 11-point Likert scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain.

  Baseline and Week 6

• Change From Baseline in Daily Pain Score for Fibromyalgia in PP Population at Week 6

  DPRS: participant rated 11-point Likert scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain.

  Baseline and Week 6

Secondary Outcomes (12)

• Change From Baseline in Sleep Interference Score for NeP in ITT Population at Week 6

  Baseline and Week 6

• Change From Baseline in Sleep Interference Score for NeP in PP Population at Week 6

  Baseline and Week 6

• Change From Baseline in Sleep Interference Score for Fibromyalgia in ITT Population at Week 6

  Baseline and Week 6

• Change From Baseline in Sleep Interference Score for Fibromyalgia in PP Population at Week 6

  Baseline and Week 6

• Number of Participants With Clinician's Global Impression of Change (CGIC) Scale for NeP in ITT Population

  Week 6

Study Arms (3)

Epilepsy

Drug: pregabalin (Lyrica)

Neuropathic Pain

Drug: pregabalin (Lyrica)

Fibromyalgia

Drug: pregabalin (Lyrica)

Interventions

pregabalin (Lyrica) DRUG

Pregabalin treatment can be started with a dose of 150 mg per day. Based on individual subject response and tolerability, the dosage may be increased to 300 mg per day after 1 week. The maximum dosage of 600 mg per day may be achieved after an additional week.

Epilepsy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Korean adult patients with epilepsy, neuropathic pain or fibromyalgia, prescribed pregabalin for within label use

You may qualify if:

• Any patient treated with pregabalin for an approved indication by Korean Food and Drug Administration

You may not qualify if:

• Non-consenting
• Hypersensitivity to the active substance or to any of the excipients
• galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Epilepsy; Neuralgia; Fibromyalgia

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Limitations and Caveats

It is highly likely that Adverse Events were under reported for this study as it was a Non Interventional study.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2010
• First Posted: October 13, 2010
• Study Start: July 1, 2006
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: January 25, 2021
• Results First Posted: December 8, 2011

Record last verified: 2011-11