Clinical trial NCT01455428: Pregabalin for Treatment of Patients With Postherpetic Neuralgia (PHN)
Official title: An 8-week Randomized, Double Blind, Multi-center, Placebo-controlled Study To Evaluate The Efficacy, Safety And Tolerability Of Pregabalin ( 300mg/Day ) Using A Fixed Dosing Schedule In The Treatment Of Subjects With Postherpetic Neuralgia ( Phn )
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postherpetic Neuralgia ( PHN )
Keywords: Pregabalin
Postherpetic Neuralgia ( PHN )
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-10-20
Enrollment: 223
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To prove pregabalin is effective in relieving pain compared with placebo in subjects with postherpetic neuralgia (PHN).


Eligibility criteria: Inclusion Criteria:

* Male or female Chinese subjects, ages ≥18 at screening
* Subjects with symptoms of neuropathic pain associated with postherpetic neuralgia (PHN). Subjects must have pain present for ﹥3 months after healing of the acute herpes zoster skin rash
* At screening (V1), subjects must have a score ≥40mm on the 100-mm visual analog scale (VAS) of the Short Form-McGill Pain Questionnaire (SF-MPQ, see Appendix 3)
* At randomization (V2), subjects must have a score ≥40mm on the 100-mm visual analog scale (VAS) of the Short Form-McGill Pain Questionnaire (SF-MPQ, see Appendix 3)
* At randomization (V2), subjects must have completed at least 5 daily pain diaries (DPRS, see Appendix 2) and have an average daily pain score ≥4 over the past 7 days

Exclusion Criteria:

* Subjects who demonstrate a high response to placebo, with 30% decrease on the Pain Visual Analog Scale (VAS) at randomization as compared to screening
* Subjects who have a high variability in pain scores during the 1 week screening period, with any difference between two scores ﹥3

Primary outcomes:
measure: Baseline Mean Pain Score
timeFrame: Baseline
measure: Change From Baseline in Mean Pain Score at Endpoint
timeFrame: Baseline until end of fixed dose phase (Day 57/Week 8)/Early Termination (Study Endpoint)
Secondary outcomes:
measure: Change From Baseline in Weekly Mean Pain Score at Weeks 1 to 8
timeFrame: Baseline and weekly from Weeks 1 to 8
measure: Baseline Mean Sleep Interference Score
timeFrame: Baseline
measure: Change From Baseline in Mean Sleep Interference Score at Endpoint
timeFrame: Baseline until end of fixed dose phase (Day 57/Week 8)/Early Termination (Study Endpoint)
measure: Change From Baseline in Weekly Mean Sleep Interference Scores at Weeks 1 to 8
timeFrame: Baseline and weekly from Weeks 1 to 8
measure: Percentage of 30 Percent (%) Responders at Endpoint
timeFrame: End of fixed dose phase (Day 57/Week 8)/Early Termination (Study Endpoint)
measure: Change From Baseline in Short Form McGill Pain Questionnaire (SF-MPQ) Score at Weeks 1, 3, 5, and 8
timeFrame: Baseline; Weeks 1, 3, 5, and 8
measure: Baseline Pain Visual Analogue Scale (VAS) and Present Pain Intensity (PPI) Scale
timeFrame: Baseline
measure: Change From Baseline in Pain VAS From the SF-MPQ at Endpoint
timeFrame: Baseline to Day 57 (Week 8)/Early Termination (Study Endpoint)
measure: Change From Baseline in PPI Scale From the SF-MPQ at Endpoint
timeFrame: Baseline to Day 57 (Week 8)/Early Termination (Study Endpoint)
measure: Baseline Medical Outcomes Study (MOS)-Sleep Scale Scores
timeFrame: Baseline
measure: Change From Baseline in MOS-Sleep Scale, Sleep Disturbance Score at Endpoint
timeFrame: Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)
measure: Change From Baseline in MOS-Sleep Scale, Snoring Score at Endpoint
timeFrame: Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)
measure: Change From Baseline in MOS-Sleep Scale, Awaken Short of Breath Score at Endpoint
timeFrame: Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)
measure: Change From Baseline in MOS-Sleep Scale, Quantity of Sleep Score at Endpoint
timeFrame: Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)
measure: Percentage of Participants Who Had Optimal Sleep at Endpoint
timeFrame: Day 57 (Week 8)/Early Termination (Study Endpoint)
measure: Change From Baseline in MOS-Sleep Scale, Sleep Adequacy Score at Endpoint
timeFrame: Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)
measure: Change From Baseline in MOS-Sleep Scale, Somnolence Score at Endpoint
timeFrame: Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)
measure: Change From Baseline in MOS-Sleep Scale, Sleep Problems Index Score at Endpoint
timeFrame: Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)
measure: Clinical Global Impression of Change (CGIC) Score at Endpoint
timeFrame: Day 57 (Week 8)/Early Termination (Study Endpoint)
measure: Patient Global Impression of Change (PGIC) Score at Endpoint
timeFrame: Day 57 (Week 8)/Early Termination (Study Endpoint)
measure: Baseline Hospital Anxiety and Depression Scale (HADS) Scores
timeFrame: Baseline
measure: Change From Baseline in HADS Anxiety Total Score at Endpoint
timeFrame: Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)
measure: Change From Baseline in HADS Depression Total Score at Endpoint
timeFrame: Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen People's Hospital
state: Guangdong
city: Wuhan
country: China
facility: Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Wuhan
country: China
facility: Tongji Hospital Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Nanjing
country: China
facility: Neurology Department, Jiangsu Province Hospital
state: Jiangsu
city: Suzhou
country: China
facility: The Second Affiliated Hospital of Soochow University/Neurology Department
state: Jiangsu
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Hangzhou
country: China
facility: The First Affiliated Hospital of College of Medicine, Zhejiang University/Dermatology and STD Dept.
state: Zhejiang
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital Affiliated of College of Medicine, Zhejiang University/Neurology Dept.
state: Zhejiang
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University/Department of Internal Neurology
city: Beijing
country: China
facility: Peking University Third Hospital, Neurology Department
city: Beijing
country: China
facility: Neurology Department, Beijing Hospital of the Ministry of Health
city: Chengdu/wuhou D
country: China
facility: West China Hospital of Sichuan University, Neurology Department
city: Chongqing
country: China
facility: the first affiliated hospital ,chongqing medical university, Department of Neurology
city: Guangzhou
country: China
facility: GuangZhou First Municipal People's Hospital
city: Guangzhou
country: China
facility: The Third Affiliated Hospital of Sun Yat-sen University
city: Shang Hai
country: China
facility: Neurology Department, Shanghai Changzheng Hospital
city: Shang Hai
country: China
facility: Huashan Hospital, Fudan University/Neurology Department
city: Shanghai
country: China
facility: Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
city: Shanghai
country: China
facility: Renji Hospital Shanghai Jiao Tong University School of Medicine/Neurology Department
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital, Dermatological Department
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: