Pregabalin for Treatment of Patients With Postherpetic Neuralgia (PHN)
- Conditions
- Postherpetic Neuralgia ( PHN )
- Interventions
- Drug: Placebo
- Registration Number
- NCT01455428
- Lead Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Brief Summary
To prove pregabalin is effective in relieving pain compared with placebo in subjects with postherpetic neuralgia (PHN).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 223
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Lyrica (pregabalin) Lyrica (pregabalin) -
- Primary Outcome Measures
Name Time Method Baseline Mean Pain Score Baseline The daily pain rating scale (DPRS) consists of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10.
Change From Baseline in Mean Pain Score at Endpoint Baseline until end of fixed dose phase (Day 57/Week 8)/Early Termination (Study Endpoint) The daily pain rating scale (DPRS) consists of an 11-point numeric scale ranging from 0 ("no pain") to 10 ("worst possible pain"). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10. The mean endpoint pain score was obtained from the last 7 available DPRS scores of the daily pain diary while the participant was on study medication, up to and including the day after the last Week 8 (Day 57) dose.
- Secondary Outcome Measures
Name Time Method Percentage of 30 Percent (%) Responders at Endpoint End of fixed dose phase (Day 57/Week 8)/Early Termination (Study Endpoint) The DPRS consists of an 11-point numeric scale ranging from 0 ("no pain") to 10 ("worst possible pain"). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10. A 30% responder was a participant who had 30% reduction or more in mean pain score at the end of the fixed dose phase (Day 57/Week 8)/Early Termination (Study Endpoint) compared to baseline.
Change From Baseline in Short Form McGill Pain Questionnaire (SF-MPQ) Score at Weeks 1, 3, 5, and 8 Baseline; Weeks 1, 3, 5, and 8 SF-MPQ was assessed according to the participant's answer to the SF-MPQ questionnaire. The score for each composite scale (sensory, affective, and total) was derived by summing the reported intensity value for each item within a particular scale where None=0, Mild=1, Moderate=2, and Severe=3. The sensory score was the sum of the scores of the first 11 pain descriptors (throbbing, shooting, stabbing, sharp, cramping, gnawing, hot-burning, aching, heavy, tender, and splitting) and could range from 0-33. The affective score was the sum of the scores of the last 4 pain descriptors (tiring-exhausting, sickening, fearful, and punishing-cruel) and could range from 0-12. The total score was the sum of the scores of all 15 pain descriptors and could range from 0 to 45. Higher scores indicated greater pain.
Baseline Pain Visual Analogue Scale (VAS) and Present Pain Intensity (PPI) Scale Baseline The VAS was part of the Short Form McGill Pain Questionnaire (SF-MPQ) scale and reflected the overall pain intensity score, The pain VAS was a horizontal line; 100 millimeters (mm) in length, was self-administered by the participant in order to rate pain from 0 (no pain) to 100 (worst possible pain). The PPI was part of the SF-MPQ scale and measured the participant's present pain intensity on a 6-point scale ranging from 0 (no pain) to 5 (excruciating).
Change From Baseline in Pain VAS From the SF-MPQ at Endpoint Baseline to Day 57 (Week 8)/Early Termination (Study Endpoint) The VAS was part of the SF-MPQ scale and reflected the overall pain intensity score. The pain VAS was a horizontal line; 100 mm in length, was self-administered by the participant in order to rate pain from 0 (no pain) to 100 (worst possible pain).
Change From Baseline in PPI Scale From the SF-MPQ at Endpoint Baseline to Day 57 (Week 8)/Early Termination (Study Endpoint) The PPI was part of the SF-MPQ scale and measured the participant's present pain intensity on a 6-point scale ranging from 0 (no pain) to 5 (excruciating).
Change From Baseline in Weekly Mean Pain Score at Weeks 1 to 8 Baseline and weekly from Weeks 1 to 8 The DPRS consists of an 11-point numeric scale ranging from 0 ("no pain") to 10 ("worst possible pain"). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10. The weekly mean pain score was the sum of the daily scores divided by the number of diary entries during that week.
Baseline Mean Sleep Interference Score Baseline Pain-related sleep interference was assessed on an 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered \[unable to sleep due to pain\]). Participants were to describe how their pain had interfered with their sleep during the past 24 hours by choosing the appropriate number between 0 and 10.
Change From Baseline in Mean Sleep Interference Score at Endpoint Baseline until end of fixed dose phase (Day 57/Week 8)/Early Termination (Study Endpoint) Pain-related sleep interference was assessed on an 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered \[unable to sleep due to pain\]). Participants were to describe how their pain had interfered with their sleep during the past 24 hours by choosing the appropriate number between 0 and 10. The mean endpoint score was obtained from the last 7 available scores of the daily diary while the participant was on study medication, up to and including the day after the last Week 8 (Day 57) dose.
Change From Baseline in Weekly Mean Sleep Interference Scores at Weeks 1 to 8 Baseline and weekly from Weeks 1 to 8 Pain-related sleep interference was assessed on an 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered \[unable to sleep due to pain\]). Participants were to describe how their pain had interfered with their sleep during the past 24 hours by choosing the appropriate number between 0 and 10. The weekly mean score was the sum of the daily scores divided by the number of diary entries during that week.
Change From Baseline in MOS-Sleep Scale, Snoring Score at Endpoint Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint) The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The snoring subscale score also ranged from 0 to 100, with lower scores indicating less snoring.
Change From Baseline in MOS-Sleep Scale, Awaken Short of Breath Score at Endpoint Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint) The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The awaken short of breath subscale also ranged from 0 to 100, with lower scores indicating less difficulty in breathing.
Change From Baseline in MOS-Sleep Scale, Quantity of Sleep Score at Endpoint Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint) The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The MOS Sleep Quantity sub-scale scores ranged from 0 to 24 (number of hours slept).
Percentage of Participants Who Had Optimal Sleep at Endpoint Day 57 (Week 8)/Early Termination (Study Endpoint) The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The MOS optimal sleep subscale was a binary outcome derived from the sleep quantity responses: the response was YES if sleep quantity was 7 or 8 hours per night.
Change From Baseline in MOS-Sleep Scale, Sleep Adequacy Score at Endpoint Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint) The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The sleep adequacy subscale also ranged from 0 to 100, with higher scores indicating greater sleep adequacy.
Change From Baseline in MOS-Sleep Scale, Somnolence Score at Endpoint Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint) The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The somnolence subscale score also ranged from 0 to 100, with lower scores indicating less somnolence.
Change From Baseline in MOS-Sleep Scale, Sleep Problems Index Score at Endpoint Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint) The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The sleep problems index subscale score also ranged from 0 to 100, with lower scores indicating fewer sleep problems.
Baseline Medical Outcomes Study (MOS)-Sleep Scale Scores Baseline The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. With the exception of sleep adequacy, optimal sleep, and quantity, higher scores reflected greater impairment in the MOS-Sleep subscales. The MOS-Sleep Scale was used to evaluate sleep during the previous week.
Change From Baseline in MOS-Sleep Scale, Sleep Disturbance Score at Endpoint Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint) The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. For sleep disturbance, the subscale score also ranged from 0 to 100, with higher scores representing greater sleep disturbance.
Clinical Global Impression of Change (CGIC) Score at Endpoint Day 57 (Week 8)/Early Termination (Study Endpoint) The CGIC was a clinician-rated global measure that provided a clinically relevant and easy to interpret account of a clinician's perception of the clinical importance of the participant's improvement or worsening during their involvement in a clinical study. Clinicians rated the participant's overall improvement on a 7-point scale where scores ranged from 1 (very much improved) to 7 (very much worse).
Patient Global Impression of Change (PGIC) Score at Endpoint Day 57 (Week 8)/Early Termination (Study Endpoint) The PGIC was a participant-rated global measure that provided a clinically relevant and easy to interpret account of a participant's perception of the clinical importance of their own improvement or worsening during their involvement in a clinical study. Participants rated their overall improvement on a 7-point scale where scores ranged from 1 (very much improved) to 7 (very much worse).
Baseline Hospital Anxiety and Depression Scale (HADS) Scores Baseline The HADS was a self-administered questionnaire that consisted of 2 subscales, 1 measuring anxiety (HADS-A Scale) and the other measuring depression (HADS-D Scale). Each subscale comprised of 7 items; participants assessed how each item applied to them on a scale of 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Subscores from HADS-A (Anxiety) and HADS-D (Depression) were not to be combined. The interpretation of each HADS subscales was as follows: 0-7 normal, 8-10 mild, 11-14 moderate and 15-21 severe.
Change From Baseline in HADS Anxiety Total Score at Endpoint Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint) The HADS was a self-administered questionnaire that consisted of 2 subscales, 1 measuring anxiety (HADS-A Scale) and the other measuring depression (HADS-D Scale). Each subscale was comprised of 7 items; participants assessed how each item applied to them on a scale of 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Subscores from HADS-A (Anxiety) and HADS-D (Depression) were not to be combined. The interpretation of each HADS subscales was as follows: 0-7 normal, 8-10 mild, 11-14 moderate and 15-21 severe.
Change From Baseline in HADS Depression Total Score at Endpoint Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint) The HADS was a self-administered questionnaire that consisted of 2 subscales, 1 measuring anxiety (HADS-A Scale) and the other measuring depression (HADS-D Scale). Each subscale was comprised of 7 items; participants assessed how each item applied to them on a scale of 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Subscores from HADS-A (Anxiety) and HADS-D (Depression) were not to be combined. The interpretation of each HADS subscales was as follows: 0-7 normal, 8-10 mild, 11-14 moderate and 15-21 severe.
Trial Locations
- Locations (22)
Peking University First Hospital
🇨🇳Beijing, Beijing, China
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
🇨🇳Guangzhou, Guangdong, China
Shenzhen People's Hospital
🇨🇳Shenzhen, Guangdong, China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
Tongji Hospital Tongji Medical College, Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
Neurology Department, Jiangsu Province Hospital
🇨🇳Nanjing, Jiangsu, China
The Second Affiliated Hospital of Soochow University/Neurology Department
🇨🇳Suzhou, Jiangsu, China
Qilu Hospital of Shandong University
🇨🇳Jinan, Shandong, China
The First Affiliated Hospital of College of Medicine, Zhejiang University/Dermatology and STD Dept.
🇨🇳Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital Affiliated of College of Medicine, Zhejiang University/Neurology Dept.
🇨🇳Hangzhou, Zhejiang, China
Scroll for more (12 remaining)Peking University First Hospital🇨🇳Beijing, Beijing, China