Phase 3 N=126 Treatment

A Long-Term Study To Evaluate Safety And Efficacy Of Pregabalin For Postherpetic Neuralgia

Neuralgia, Postherpetic

Bottom Line

View on ClinicalTrials.gov: NCT00424372 ↗

Enrolled (actual)

126

Serious AEs

11.9%

Results posted

Sep 2009

Primary outcome: Primary: Summary of Adverse Events — 124; 14; 5; 17 subjects

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: pregabalin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Primary completion: Aug 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Summary of Adverse Events	124; 14; 5; 17; 34	—
SECONDARY Short-Form McGill Pain Questionnaire the Efficacy of Change: Sensory Score	11.3; 5.1; 6.7; -4.8	—
SECONDARY Short-Form McGill Pain Questionnaire the Efficacy of Change: Affective Score	3.4; 1.0; 1.7; -1.8	—
SECONDARY Short-Form McGill Pain Questionnaire the Efficacy of Change: Total Score	14.7; 6.1; 8.2; -6.5	—
SECONDARY Short-Form McGill Pain Questionnaire the Efficacy of Change: Present Pain Intensity	2.8; 1.4; 1.7; -1.1	—
SECONDARY Short-Form McGill Pain Questionnaire the Efficacy of Change: Visual Analog Scale	62.0; 28.3; 33.7; -28.3	—

Summary

To evaluate the safety of the long-term use of pregabalin.

Eligibility Criteria

Inclusion Criteria

Patients who completed the 13-week treatment of postherpetic neuralgia in Study A0081120.
Patients must be able to understand and cooperate with study procedures and have signed a written informed consent prior to entering the study.

Exclusion Criteria

Patients who experienced serious adverse events in the preceding study (A0081120) that were determined by the investigator or the study sponsor to be causally related to the study medication.
Patients exhibiting treatment non-compliance in the preceding study (A0081120)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00424372). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.