A double blind, randomised, placebo controlled trial of the time to onset of meaningful 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

Pfizer Ltd0 个研究点目标入组 255 人开始时间: 2005年2月23日最近更新: 2020年7月27日

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•Male and female patients over 18 years of age
•Females of child bearing potential must have a negative serum pregnancy test and be practising an acceptable form of contraception (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 apart 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.
•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

•In-patients
•Women who are pregnant or lactating or not practising an acceptable method of contraception
•History of neurolytic or neurosurgical therapy
•Neurological disorders that may confuse or confound the assessment of neuropathic pain.
•Presence of any severe pain 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 <100x103/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

发起方