Safety And Efficacy Study Of Once Daily Controlled Release Pregabalin In The Treatment Of Patients With Postherpetic Neuralgia

This study has been completed.
Information provided by (Responsible Party):
Pfizer Identifier:
First received: January 4, 2011
Last updated: September 30, 2015
Last verified: September 2015
The purpose of the study is to explore the safety and efficacy of a new once a day pregabalin formulation versus placebo for patients with post herpetic neuralgia (Shingles)

Condition Intervention Phase
Post Herpetic Neuralgia
Drug: Pregabalin
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3 Double-blind, Randomized, Placebo-controlled, Safety And Efficacy Study Of Once Daily Controlled Release Pregabalin In The Treatment Of Patients With Postherpetic Neuralgia (Protocol A0081224)

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Time to loss of therapeutic response (LTR), defined as <30% pain response relative to the baseline phase or patient discontinuation due to lack of efficacy or adverse events, in the double blind phase of the study. [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain numeric rating scale (NRS); 1 week recall period [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
  • Medical Outcomes Study (MOS) Sleep Scale total score and each sub domain [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
  • Patient Global Impression of Change (PGIC). [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
  • Short Form 36 Health Survey (SF 36). [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
  • Daily sleep interference diary [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
  • Hospital Anxiety and Depression Scale (HADS). [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
  • Brief Pain Inventory (BPI sf). [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
  • Benefit, Satisfaction, Willingness to Continue Measure (BSW). [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
  • Adverse events. [ Time Frame: 19 weeks ] [ Designated as safety issue: Yes ]
  • Suicidality assessments (STS). [ Time Frame: 13 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 812
Study Start Date: March 2011
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pregablain CR tablet 82.5 to 660mg Drug: Pregabalin
Tablets, 82.5 to 660mg, once per day. Duration: 19 weeks
Placebo Comparator: Placebo Drug: placebo
Placebo, 82.5 to 660mg, once per day. Duration: 13 weeks


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients must have pain present for more than 3 months after the healing of the herpes zoster skin rash.
  • At screening (V1) and enrollment (V2), patients must have a score of greater than or equal to 4 on the Pain Numeric Rating Scale (1 week recall period).
  • At enrollment (V2), at least 4 pain diaries must be completed satisfactorily within the last 7 days and the average pain score must be greater than or equal to 4.
  • Male or female of any race, at least 18 years of age, and using appropriate methods of contraception

Exclusion Criteria:

  • Creatinine clearance <30 mL/min (estimated from serum creatinine).
  • Skin conditions in the affected dermatome that could alter sensation
  • Pregabalin use in the last 30 days. Subjects taking pregabalin in the last 30 days should be washed out of pregabalin for at least 30 days prior to screening visit. Patients who had not responded to pregabalin
  Contacts and Locations
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Please refer to this study by its identifier: NCT01270828

  Show 146 Study Locations
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer Identifier: NCT01270828     History of Changes
Other Study ID Numbers: A0081224, 2009-016766-86
Study First Received: January 4, 2011
Last Updated: September 30, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Control Release Pregabalin in Post Herpetic Neuralgia

Additional relevant MeSH terms:
Neuralgia, Postherpetic
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Diseases
Peripheral Nervous System Diseases
Signs and Symptoms
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses processed this record on November 25, 2015