Pilot Study Of Pregabalin And Prediction Of Treatment Response In Patients With Postherpetic Neuralgia

NCT01603394 | Terminated Phase 4 Results

• 1 other identifier: A9001464
• Study Type: interventional
• Target: 9
• Locations: 4 countries
• Sites: 9

Brief Summary

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

Conditions

Postherpetic Neuralgia

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the Daily Pain Diary (Numerical Rating Scale, NRS) Mean Pain Score at the End of the Study (Week 6).

  The numeric rating scale for pain (NRS-Pain) consists of an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain.

  Baseline, Week 6

Secondary Outcomes (11)

• Neuropathic Pain Symptom Inventory (NPSI) at All Visits.

  All visits

• Proportion of Phenotypes Within the 30% and 50% Responder Groups at Baseline and Week 6.

  Baseline, Week 6

• Patient Global Impression of Change (PGIC) at Week 6/Early Termination.

  Week 6/Early Termination

• Proportions of Participants With >/=30% and >/=50% Pain Reduction Based on Daily Pain Diary at Baseline and Week 6.

  Baseline, Week 6

• 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.

  Baseline, Week 6

Study Arms (1)

Pregabalin (300-600 mg/day; 150 mg/day starting dose)

EXPERIMENTAL

Drug: pregabalin

Interventions

pregabalin DRUG

Pregabalin Capsules (150 mg - 600mg), Dose titration (4 weeks) and fixed dose (2 weeks) for a 6 week treatment period.

Pregabalin (300-600 mg/day; 150 mg/day starting dose)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (9)

Pfizer Investigational Site

Leesburg, Florida, 34748, United States

Location

Pfizer Investigational Site

Lexington, Kentucky, 40509, United States

Location

Pfizer Investigational Site

Raleigh, North Carolina, 27612, United States

Location

Pfizer Investigational Site

Jekintown, Pennsylvania, 19046, United States

Location

Pfizer Investigational Site

Senftenberg, A-3541, Austria

Location

Pfizer Investigational Site

Vienna, A-1010, Austria

Location

Pfizer Investigational Site

Schwerin, 19053, Germany

Location

Pfizer Investigational Site

Pretoria, Gauteng, 0122, South Africa

Location

Pfizer Investigational Site

Paarl, Western Cape, 7626, South Africa

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Neuralgia, Postherpetic

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; 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

Limitations and Caveats

Outcome measure PCS was removed in protocol amendment1. Study stopped due to low enrolment and not safety. Efficacy analyses were not performed; safety results are described. Overall risk-benefit of pregabalin has not changed due to trial termination

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@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: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2012
• First Posted: May 22, 2012
• Study Start: October 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: July 8, 2014
• Results First Posted: July 8, 2014

Record last verified: 2014-06

Locations

US (4); DE (1); AU (2); ZA (2)