A double blind, randomised, placebo controlled trial of the time to onset meaningful of pain relief in subjects with post herpetic neuralgia (PHN) treated with pregabalin (150-600 mg /day flexible optimised dose or 300 mg/day fixed dose) or placebo - n/a

Phase 1

• Conditions: post herpetic neuralgia; MedDRA version: 7Level: LLTClassification code 10036376

• Registration Number: EUCTR2004-002563-24-ES
• Lead Sponsor: PFIZER, S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-11-30
• Study Completion: 2006-06-28
• Last Update Posted: 2 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 255

Inclusion Criteria

Male and female patients over 18 years of age
Females of child bearing potential must have a negative serum pregnancy test and be practising aan effective form of contraception (acceptable methods :hormonal, barrier or IUD)
Diagnosis of PHN with pain present for at least 3 months after healing of Herpes zoster lesions.
Pain score of at least 40 mm on the 100 mm visual analogue scale both at screening and randomisation visits.
Subjects must have completed the Daily Pain Rating Scale in the electronic diary at least 4 times during screening and have an average pain rating score of >4 during the 7 days prior to randomisation.
Subjects must be in generally good health a part from PHN.
Subjects are permitted to continue with other pharmacological or non-pharmacological treatments for pain associated with PHN, but not to change or initiate new treatments
Subject is willing and able to comply with scheduled visits, treatment plan, laboratory tests and other trial procedures.
Informed consent evidence personnaly signed and dated by the subject.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

In-patient medical care.
Women who are pregnant or lactating or of child bearing potential not practising an effective method of contraception
History of neurolytic or neurosurgical therapy
Neurological disorders unrelated to PHN that may confuse or confound the assessment of neuropathic pain.
Presence of any severe pain unrelated to PHN that could confuse or confound the assessment of neuropathic pain.
Skin condition in the affected dermatome that could alter sensation
Other clinically significant or unstable medical conditions
Creatinine clearance < 60 ml/min
Liver function tests >3x ULN
Clinically significant abnormal ECG
Clinically significant congestive heart failure
History of pernicious anaemia or untreated hypothyroidism
Malignancy within the past 2 years
Active hepatitis B or C, HIV infection or other significant infection in the past 3 months
Anticipated need for surgery
Total white blood cell count <2500/c. mm or platelet count <100x1000/c.mm
Drug or alcohol abuse in the past 2 years
History of intolerance or hypersensitivity to pregabalin, gabapentin or drugs with similar chemical structures
Participation in previous trials with pregabalin
Participation in any other study within 30 days of screening

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified