Back to resultsPregabalin for Treatment of Patients With Postherpetic Neuralgia (PHN)
Primary Purpose
Postherpetic Neuralgia ( PHN )
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Lyrica (pregabalin)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Postherpetic Neuralgia ( PHN ) focused on measuring Pregabalin, 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
Sites / Locations
- Peking University First Hospital
- Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
- Shenzhen People's Hospital
- Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
- Tongji Hospital Tongji Medical College, Huazhong University of Science and Technology
- Neurology Department, Jiangsu Province Hospital
- The Second Affiliated Hospital of Soochow University/Neurology Department
- Qilu Hospital of Shandong University
- The First Affiliated Hospital of College of Medicine, Zhejiang University/Dermatology and STD Dept.
- Sir Run Run Shaw Hospital Affiliated of College of Medicine, Zhejiang University/Neurology Dept.
- Beijing Friendship Hospital, Capital Medical University/Department of Internal Neurology
- Peking University Third Hospital, Neurology Department
- Neurology Department, Beijing Hospital of the Ministry of Health
- West China Hospital of Sichuan University, Neurology Department
- the first affiliated hospital ,chongqing medical university, Department of Neurology
- GuangZhou First Municipal People's Hospital
- The Third Affiliated Hospital of Sun Yat-sen University
- Neurology Department, Shanghai Changzheng Hospital
- Huashan Hospital, Fudan University/Neurology Department
- Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
- Renji Hospital Shanghai Jiao Tong University School of Medicine/Neurology Department
- Tianjin Medical University General Hospital, Dermatological Department
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Lyrica (pregabalin)
Placebo
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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 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.
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.
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.
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.
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 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).
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).
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 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.
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.
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.
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.
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).
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.
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.
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.
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.
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).
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).
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.
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.
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.
Full Information
NCT ID
NCT01455428
First Posted
October 17, 2011
Last Updated
January 26, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01455428
Brief Title
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
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To prove pregabalin is effective in relieving pain compared with placebo in subjects with postherpetic neuralgia (PHN).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postherpetic Neuralgia ( PHN )
Keywords
Pregabalin, Postherpetic Neuralgia ( PHN )
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
223 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lyrica (pregabalin)
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Lyrica (pregabalin)
Intervention Description
Capsule, 300 mg/d, BID, 8 weeks treatment
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Capsule, 300 mg/d, BID, 8 weeks treatment
Primary Outcome Measure Information:
Title
Baseline Mean Pain Score
Description
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.
Time Frame
Baseline
Title
Change From Baseline in Mean Pain Score at Endpoint
Description
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.
Time Frame
Baseline until end of fixed dose phase (Day 57/Week 8)/Early Termination (Study Endpoint)
Secondary Outcome Measure Information:
Title
Change From Baseline in Weekly Mean Pain Score at Weeks 1 to 8
Description
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.
Time Frame
Baseline and weekly from Weeks 1 to 8
Title
Baseline Mean Sleep Interference Score
Description
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.
Time Frame
Baseline
Title
Change From Baseline in Mean Sleep Interference Score at Endpoint
Description
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.
Time Frame
Baseline until end of fixed dose phase (Day 57/Week 8)/Early Termination (Study Endpoint)
Title
Change From Baseline in Weekly Mean Sleep Interference Scores at Weeks 1 to 8
Description
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.
Time Frame
Baseline and weekly from Weeks 1 to 8
Title
Percentage of 30 Percent (%) Responders at Endpoint
Description
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.
Time Frame
End of fixed dose phase (Day 57/Week 8)/Early Termination (Study Endpoint)
Title
Change From Baseline in Short Form McGill Pain Questionnaire (SF-MPQ) Score at Weeks 1, 3, 5, and 8
Description
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.
Time Frame
Baseline; Weeks 1, 3, 5, and 8
Title
Baseline Pain Visual Analogue Scale (VAS) and Present Pain Intensity (PPI) Scale
Description
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).
Time Frame
Baseline
Title
Change From Baseline in Pain VAS From the SF-MPQ at Endpoint
Description
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).
Time Frame
Baseline to Day 57 (Week 8)/Early Termination (Study Endpoint)
Title
Change From Baseline in PPI Scale From the SF-MPQ at Endpoint
Description
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).
Time Frame
Baseline to Day 57 (Week 8)/Early Termination (Study Endpoint)
Title
Baseline Medical Outcomes Study (MOS)-Sleep Scale Scores
Description
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.
Time Frame
Baseline
Title
Change From Baseline in MOS-Sleep Scale, Sleep Disturbance Score at Endpoint
Description
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.
Time Frame
Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)
Title
Change From Baseline in MOS-Sleep Scale, Snoring Score at Endpoint
Description
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.
Time Frame
Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)
Title
Change From Baseline in MOS-Sleep Scale, Awaken Short of Breath Score at Endpoint
Description
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.
Time Frame
Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)
Title
Change From Baseline in MOS-Sleep Scale, Quantity of Sleep Score at Endpoint
Description
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).
Time Frame
Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)
Title
Percentage of Participants Who Had Optimal Sleep at Endpoint
Description
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.
Time Frame
Day 57 (Week 8)/Early Termination (Study Endpoint)
Title
Change From Baseline in MOS-Sleep Scale, Sleep Adequacy Score at Endpoint
Description
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.
Time Frame
Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)
Title
Change From Baseline in MOS-Sleep Scale, Somnolence Score at Endpoint
Description
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.
Time Frame
Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)
Title
Change From Baseline in MOS-Sleep Scale, Sleep Problems Index Score at Endpoint
Description
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.
Time Frame
Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)
Title
Clinical Global Impression of Change (CGIC) Score at Endpoint
Description
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).
Time Frame
Day 57 (Week 8)/Early Termination (Study Endpoint)
Title
Patient Global Impression of Change (PGIC) Score at Endpoint
Description
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).
Time Frame
Day 57 (Week 8)/Early Termination (Study Endpoint)
Title
Baseline Hospital Anxiety and Depression Scale (HADS) Scores
Description
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.
Time Frame
Baseline
Title
Change From Baseline in HADS Anxiety Total Score at Endpoint
Description
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.
Time Frame
Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)
Title
Change From Baseline in HADS Depression Total Score at Endpoint
Description
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.
Time Frame
Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Facility Name
Shenzhen People's Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518020
Country
China
Facility Name
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Facility Name
Tongji Hospital Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Facility Name
Neurology Department, Jiangsu Province Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Facility Name
The Second Affiliated Hospital of Soochow University/Neurology Department
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215004
Country
China
Facility Name
Qilu Hospital of Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Facility Name
The First Affiliated Hospital of College of Medicine, Zhejiang University/Dermatology and STD Dept.
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Facility Name
Sir Run Run Shaw Hospital Affiliated of College of Medicine, Zhejiang University/Neurology Dept.
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310016
Country
China
Facility Name
Beijing Friendship Hospital, Capital Medical University/Department of Internal Neurology
City
Beijing
ZIP/Postal Code
100050
Country
China
Facility Name
Peking University Third Hospital, Neurology Department
City
Beijing
ZIP/Postal Code
100191
Country
China
Facility Name
Neurology Department, Beijing Hospital of the Ministry of Health
City
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
West China Hospital of Sichuan University, Neurology Department
City
Chengdu/wuhou D
ZIP/Postal Code
610041
Country
China
Facility Name
the first affiliated hospital ,chongqing medical university, Department of Neurology
City
Chongqing
ZIP/Postal Code
400016
Country
China
Facility Name
GuangZhou First Municipal People's Hospital
City
Guangzhou
ZIP/Postal Code
510180
Country
China
Facility Name
The Third Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
ZIP/Postal Code
510630
Country
China
Facility Name
Neurology Department, Shanghai Changzheng Hospital
City
Shang Hai
ZIP/Postal Code
200003
Country
China
Facility Name
Huashan Hospital, Fudan University/Neurology Department
City
Shang Hai
ZIP/Postal Code
200040
Country
China
Facility Name
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
City
Shanghai
ZIP/Postal Code
200025
Country
China
Facility Name
Renji Hospital Shanghai Jiao Tong University School of Medicine/Neurology Department
City
Shanghai
ZIP/Postal Code
200127
Country
China
Facility Name
Tianjin Medical University General Hospital, Dermatological Department
City
Tianjin
ZIP/Postal Code
300052
Country
China
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0081276&StudyName=Pregabalin%20for%20Treatment%20of%20Patients%20with%20Postherpetic%20Neuralgia%20%28PHN%29%20
Description
To obtain contact information for a study center near you, click here.
Learn more about this trial
Pregabalin for Treatment of Patients With Postherpetic Neuralgia (PHN)
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