Pregabalin for Treatment of Patients With Postherpetic Neuralgia (PHN)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01455428
First received: October 17, 2011
Last updated: May 20, 2015
Last verified: May 2015
  Purpose

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


Condition Intervention Phase
Postherpetic Neuralgia ( PHN )
Drug: Lyrica (pregabalin)
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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 )

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Baseline Mean Pain Score [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline until end of fixed dose phase (Day 57/Week 8)/Early Termination (Study Endpoint) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and weekly from Weeks 1 to 8 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline until end of fixed dose phase (Day 57/Week 8)/Early Termination (Study Endpoint) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and weekly from Weeks 1 to 8 ] [ Designated as safety issue: No ]
    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 [ Time Frame: End of fixed dose phase (Day 57/Week 8)/Early Termination (Study Endpoint) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline; Weeks 1, 3, 5, and 8 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to Day 57 (Week 8)/Early Termination (Study Endpoint) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to Day 57 (Week 8)/Early Termination (Study Endpoint) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 57 (Week 8)/Early Termination (Study Endpoint) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 57 (Week 8)/Early Termination (Study Endpoint) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 57 (Week 8)/Early Termination (Study Endpoint) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint) ] [ Designated as safety issue: No ]
    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.


Enrollment: 223
Study Start Date: December 2011
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lyrica (pregabalin) Drug: Lyrica (pregabalin)
Capsule, 300 mg/d, BID, 8 weeks treatment
Placebo Comparator: Placebo Drug: Placebo
Capsule, 300 mg/d, BID, 8 weeks treatment

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01455428

Locations
China, Beijing
Peking University First Hospital
Beijing, Beijing, China, 100034
China, Guangdong
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China, 510120
Shenzhen People's Hospital
Shenzhen, Guangdong, China, 518020
China, Hubei
Tongji Hospital Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
China, Jiangsu
Neurology Department, Jiangsu Province Hospital
Nanjing, Jiangsu, China, 210029
The Second Affiliated Hospital of Soochow University/Neurology Department
Suzhou, Jiangsu, China, 215004
China, Shandong
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250012
China, Zhejiang
The First Affiliated Hospital of College of Medicine, Zhejiang University/Dermatology and STD Dept.
Hangzhou, Zhejiang, China, 310003
Sir Run Run Shaw Hospital Affiliated of College of Medicine, Zhejiang University/Neurology Dept.
Hangzhou, Zhejiang, China, 310016
China
Beijing Friendship Hospital, Capital Medical University/Department of Internal Neurology
Beijing, China, 100050
Neurology Department, Beijing Hospital of the Ministry of Health
Beijing, China, 100730
Peking University Third Hospital, Neurology Department
Beijing, China, 100191
West China Hospital of Sichuan University, Neurology Department
Chengdu/wuhou D, China, 610041
the first affiliated hospital ,chongqing medical university, Department of Neurology
Chongqing, China, 400016
GuangZhou First Municipal People's Hospital
Guangzhou, China, 510180
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, China, 510630
Huashan Hospital, Fudan University/Neurology Department
Shang Hai, China, 200040
Neurology Department, Shanghai Changzheng Hospital
Shang Hai, China, 200003
Renji Hospital Shanghai Jiao Tong University School of Medicine/Neurology Department
Shanghai, China, 200127
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, China, 200025
Tianjin Medical University General Hospital, Dermatological Department
Tianjin, China, 300052
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01455428     History of Changes
Other Study ID Numbers: A0081276
Study First Received: October 17, 2011
Results First Received: January 8, 2015
Last Updated: May 20, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Pregabalin
Postherpetic Neuralgia ( PHN )

Additional relevant MeSH terms:
Neuralgia
Neuralgia, Postherpetic
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Diseases
Pain
Peripheral Nervous System Diseases
Signs and Symptoms
Pregabalin
Analgesics
Anticonvulsants
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2015