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

PFIZER, S.A.0 个研究点目标入组 255 人开始时间: 2005年11月30日最近更新: 2021年8月2日

试验速览

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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 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

•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

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