Pregabalin for Treatment of Patients With Postherpetic Neuralgia (PHN)

Study Overview
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Brief Summary
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To prove pregabalin is effective in relieving pain compared with placebo in subjects with postherpetic neuralgia (PHN).

Official Title
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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 )

Conditions
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Postherpetic Neuralgia ( PHN )

Intervention / Treatment
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* Drug: Lyrica (pregabalin)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lyrica (pregabalin)<br> | Drug: Lyrica (pregabalin)<br>* Capsule, 300 mg/d, BID, 8 weeks treatment<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Capsule, 300 mg/d, BID, 8 weeks treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline Mean Pain Score | 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. | Baseline | 
| Change From Baseline in Mean Pain Score at 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. | Baseline until end of fixed dose phase (Day 57/Week 8)/Early Termination (Study Endpoint) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Weekly Mean Pain Score at 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 and weekly from Weeks 1 to 8 | 
| Baseline Mean Sleep Interference Score | 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. | Baseline | 
| Change From Baseline in Mean Sleep Interference Score at 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. | Baseline until end of fixed dose phase (Day 57/Week 8)/Early Termination (Study Endpoint) | 
| Change From Baseline in Weekly Mean Sleep Interference Scores at 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. | Baseline and weekly from Weeks 1 to 8 | 
| Percentage of 30 Percent (%) Responders at 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. | End of fixed dose phase (Day 57/Week 8)/Early Termination (Study Endpoint) | 
| Change From Baseline in Short Form McGill Pain Questionnaire (SF-MPQ) Score at 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; Weeks 1, 3, 5, and 8 | 
| Baseline Pain Visual Analogue Scale (VAS) and Present Pain Intensity (PPI) Scale | 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). | Baseline | 
| Change From Baseline in Pain VAS From the SF-MPQ at 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). | Baseline to Day 57 (Week 8)/Early Termination (Study Endpoint) | 
| Change From Baseline in PPI Scale From the SF-MPQ at 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). | Baseline to Day 57 (Week 8)/Early Termination (Study Endpoint) | 
| Baseline Medical Outcomes Study (MOS)-Sleep Scale Scores | 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. | Baseline | 
| Change From Baseline in MOS-Sleep Scale, Sleep Disturbance Score at 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. | Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint) | 
| Change From Baseline in MOS-Sleep Scale, Snoring Score at 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. | Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint) | 
| Change From Baseline in MOS-Sleep Scale, Awaken Short of Breath Score at 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. | Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint) | 
| Change From Baseline in MOS-Sleep Scale, Quantity of Sleep Score at 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). | Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint) | 
| Percentage of Participants Who Had Optimal Sleep at 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. | Day 57 (Week 8)/Early Termination (Study Endpoint) | 
| Change From Baseline in MOS-Sleep Scale, Sleep Adequacy Score at 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. | Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint) | 
| Change From Baseline in MOS-Sleep Scale, Somnolence Score at 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. | Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint) | 
| Change From Baseline in MOS-Sleep Scale, Sleep Problems Index Score at 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 and Day 57 (Week 8)/Early Termination (Study Endpoint) | 
| Clinical Global Impression of Change (CGIC) Score at 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). | Day 57 (Week 8)/Early Termination (Study Endpoint) | 
| Patient Global Impression of Change (PGIC) Score at 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). | Day 57 (Week 8)/Early Termination (Study Endpoint) | 
| Baseline Hospital Anxiety and Depression Scale (HADS) Scores | 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. | Baseline | 
| Change From Baseline in HADS Anxiety Total Score at 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. | Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint) | 
| Change From Baseline in HADS Depression Total Score at 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. | Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregabalin, Postherpetic Neuralgia ( PHN )