A Post Marketing Surveillance Study On Pregabalin (Lyrica) On Efficacy, Safety And Tolerability Of Pregabalin

NCT00892008 | Completed Results

• 1 other identifier: A0081094
• Study Type: observational
• Target: 2,278
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is being conducted as a regulatory requirement post initial marketing authorization. This is primarily a safety study. This was an open label study and patients were enrolled once the decision to prescribe the medication was made by the Investigator.

Conditions

Neuropathic Pain

Keywords

pregabalin; neuropathic pain; safety

Outcome Measures

Primary Outcomes (2)

• Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)

  Number and severity of adverse events, including serious adverse events. If the same subject had more than one occurance in the same preferred term event category, only the most severe occurrence was taken.

  Baseline through Final Visit (Week 4)

• Discontinuations Due to Adverse Events

  Discontinuations due to adverse events by MedDRA system organ class and preferred term.

  Baseline, Second Visit (Week ≥ 2), Final Visit (Week 4)

Secondary Outcomes (9)

• Change From Baseline in Visual Analogue Scale (VAS) Score

  Baseline, Second Visit (Week ≥ 2), Final Visit (Week 4)

• VAS Pain Score at Baseline (BL) and Second Visit

  Baseline, Second Visit (Week ≥ 2)

• VAS Pain Score at Baseline and Final Visit

  Baseline, Final Visit (Week 4)

• Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits

  Second Visit (Week ≥ 2), Final Visit (Week 4)

• Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits

  Second Visit (Week ≥ 2), Final Visit (Week 4)

Study Arms (1)

Open-Label

This study was open-label with only one treatment group. Pregabalin was prescribed in accordance with usual clinical practice.

Drug: Pregabalin

Interventions

Pregabalin DRUG

Pregabalin 75-150 mg BID for at least 2 weeks.

Also known as: Lyrica

Open-Label

Eligibility Criteria

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

Study Population

Male or female, 18 years and above diagnosed with neuropathic pain.

You may qualify if:

• Male or female, 18 years old and above diagnosed with neuropathic pain.

You may not qualify if:

• Patients that are pregnant and lactating; and patients with known hypersensitivity to pregabalin or its related components.

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

Neuralgia

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

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

ClinicalTrials.govCallCenter@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: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2009
• First Posted: May 1, 2009
• Study Start: September 1, 2006
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: January 25, 2021
• Results First Posted: November 18, 2009

Record last verified: 2010-01