Symptomatic Treatment Of Patients With Neuropathic Pain With LYRICA

NCT00843284 | Completed Results

• 2 other identifiers: A0081139ATLAS
• Study Type: observational
• Target: 691
• Locations: 0 countries
• Sites: N/A

Brief Summary

A Non-Interventional, Post-Marketing Surveillance (NI-PMS) study whose objectives were to assess the impact of pregabalin on subjects' pain, quality of sleep, and their general wellbeing, as well as the tolerance and safety of pregabalin in subjects with neuropathic pain.

Conditions

Neuropathic Pain

Keywords

neuropathic, pain, pregabalin, Lyrica

Outcome Measures

Primary Outcomes (2)

• Daily Average Pain Scores

  Change is observed value at final visit (Week 8 or discontinuation) minus baseline value. Daily average pain score is measured using a 10-point Likert scale where 0 = no pain to 10 = pain as bad as you can imagine.

  Baseline, Final Visit (Week 8 or discontinuation)

• Pain Related Sleep Interference

  Change is observed value at final visit (Week 8 or discontinuation) minus baseline value. Pain related sleep interference is measured by a 10-point Likert scale where 0 = does not interfere with sleep, and 10 = completely interferes with sleep

  Baseline, Final Visit (Week 8 or discontinuation)

Secondary Outcomes (3)

• Anxiety and Depression Symptoms

  Baseline, Final Visit (Week 8 or discontinuation)

• Clinician Global Improvement of Change (CGIC) at Final Visit (Week 8 or Discontinuation)

  Final Visit (Week 8 or discontinuation)

• Patient Global Improvement of Change (PGIC) at Final Visit (Week 8 or Discontinuation)

  Final Visit (Week 8 or discontinuation)

Study Arms (1)

Patients with neuropathic pain

Drug: Pregabalin

Interventions

Pregabalin DRUG

Capsules, 150 - 600 mg/day, 2-3 times/day, 8 weeks

Patients with neuropathic pain

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

Patients with neuropathic pain

You may not qualify if:

• The patients were excluded according to the current Summary of Product Characteristics.

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; Pain

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; 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: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2009
• First Posted: February 13, 2009
• Study Start: September 1, 2006
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: February 10, 2021
• Results First Posted: April 16, 2009

Record last verified: 2009-10