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

This study has suspended participant recruitment.
(The study has enrolled the required number of subjects. Pfizer is evaluating statistical assumptions and also deviations related to dosing procedures)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01270828
First received: January 4, 2011
Last updated: June 30, 2014
Last verified: June 2014
  Purpose

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 ]

Estimated Enrollment: 800
Study Start Date: February 2011
Estimated Study Completion Date: September 2014
Estimated 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

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01270828

  Show 153 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01270828     History of Changes
Other Study ID Numbers: A0081224
Study First Received: January 4, 2011
Last Updated: June 30, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Neuralgia
Neuralgia, Postherpetic
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants

ClinicalTrials.gov processed this record on July 22, 2014