Clinical trial NCT01603394: Pilot Study Of Pregabalin And Prediction Of Treatment Response In Patients With Postherpetic Neuralgia
Official title: A Phase 4 Multicenter, Open-Label, Pilot Study Of Pregabalin And Prediction Of Treatment Response In Patients With Postherpetic Neuralgia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Postherpetic Neuralgia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-05-22
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective is to explore whether sensory symptom cluster analysis is useful for predicting treatment response in Postherpetic Neuralgia.

Detailed description: The study was stopped on 26 April 2013 due to feasibility issues (low enrollment) not safety. The overall risk-benefit of Lyrica has not changed at all due to termination of this trial. Only 9 of the 150 patients were enrolled into the trial, so we are unable to get adequate results from this study.

Eligibility criteria: Inclusion Criteria:

* Subjects must have pain present for more than 3 months after the healing of the herpes zoster skin rash.
* At screening (V1) and baseline (V2), subjects must have a score of \>=4 on the Numeric Rating Scale for Pain (1 week recall period).
* At baseline (V2), at least 4 pain diaries must be completed satisfactorily within the last 7 days and the average pain score must be \>=4.

Exclusion Criteria:

* Subjects having other severe pain that may confound assessment or self evaluation of the pain due to PHN.
* Neurolytic or neurosurgical therapy for Postherpetic Neuralgia
* Skin conditions in the affected dermatome that could alter sensation.

Primary outcomes:
measure: Change From Baseline in the Daily Pain Diary (Numerical Rating Scale, NRS) Mean Pain Score at the End of the Study (Week 6).
timeFrame: Baseline, Week 6
Secondary outcomes:
measure: Neuropathic Pain Symptom Inventory (NPSI) at All Visits.
timeFrame: All visits
measure: Proportion of Phenotypes Within the 30% and 50% Responder Groups at Baseline and Week 6.
timeFrame: Baseline, Week 6
measure: Patient Global Impression of Change (PGIC) at Week 6/Early Termination.
timeFrame: Week 6/Early Termination
measure: Proportions of Participants With >/=30% and >/=50% Pain Reduction Based on Daily Pain Diary at Baseline and Week 6.
timeFrame: Baseline, Week 6
measure: Proportion of Participants Within Each Phenotype Group as Determined by Sensory Symptom Clustering Using the PainPREDICT, PainDETECT and Neuropathic Pain Symptom Inventory at Baseline and Week 6.
timeFrame: Baseline, Week 6
measure: Patient Health Questionnaire-8 (PHQ-8) at Baseline and Week 6; Generalized Anxiety Disorder-7 (GAD-7) at Screening, Visit 2 (Week 0) and Week 6/Early Termination.
timeFrame: Screening, Visit 2 (Week 0) and Week 6/Early Termination
measure: Brief Pain Inventory (BPI sf) at Visit 2 (Week 0) and Week 6.
timeFrame: Visit 2 (Week 0), Week 6
measure: Patient Catastrophizing Scale (PCS) at Visit 2 (Week 0) and Week 6.
timeFrame: Visit 2 (Week 0), Week 6
measure: Pain NRS Score; 1 Week Recall Period.
timeFrame: 1 Week
measure: Short Form 12v2 Health Survey (SF 12v2) at Visit 2 (Week 0), and Week 6/Early Termination.
timeFrame: Visit 2 (Week 0), and Week 6/Early Termination
measure: Change From Baseline to End of the Study (Week 6) in the Daily Sleep Interference Diary (NRS) Mean Pain Score.
timeFrame: Baseline, Week 6
Other outcomes:
Locations:
city: Leesburg
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Lexington
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Raleigh
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Jekintown
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Senftenberg
country: Austria
facility: Pfizer Investigational Site
state: A-3541
city: Wien
country: Austria
facility: Pfizer Investigational Site
city: Schwerin
country: Germany
facility: Pfizer Investigational Site
city: Pretoria
country: South Africa
facility: Pfizer Investigational Site
state: Gauteng
city: Paarl
country: South Africa
facility: Pfizer Investigational Site
state: Western Cape
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: