Study To Evaluate Efficacy, Safety And Tolerability Of Lyrica In Patients With Painful Diabetic Peripheral Neuropathy
- Conditions
- Diabetic Neuropathy, Painful
- Interventions
- Registration Number
- NCT01332149
- Lead Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Brief Summary
Pregabalin has proven effective in previous clinical trails in other countries in relieving neuropathic pain associated with postherpetic neuralgia and painful diabetic neuropathy.
This study is being conducted according to China registration requirement to submit a reapplication with new local diabetic peripheral neuropathy study as a commitment plus the existing data to apply for Lyrica "pain associated with postherpetic neuralgia" indication after Lyrica "pain associated with postherpetic neuralgia" is approved.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 626
- Male and female subjects aged 18 years or older
- Diagnosis of painful, distal, symmetrical, sensorimotor polyneuropathy which is due to diabetes mellitus (Type 1 or 2), and symptoms of painful diabetic neuropathy for 6 months to 5 years (inclusive).
- At the baseline and randomization visits, a score of ≥50 mm on the Visual Analogue Scale, at randomization, subjects must have completed at least 5 daily pain interference diaries, and have an average daily pain score of ≥5 over the past 7 days.
- Patient who are willing and capable to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Women of childbearing potential are willing to use contraception during study.
- Subjects with more than 30% decrease on the Pain Visual Analog Scale at randomization as compared to screening; and during the 1 week screening period, with more than one pain score <3 in pain scores.
- Subject has other kinds of neurological disorder, pain of other reason, or skin condition that could confuse the assessment.
- Subject with any other serious or unstable condition which in the opinion of the investigator might compromise participation in the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo matched with pregabalin - 300 mg/day pregabalin (Lyrica) Pregabalin Patient take pregabalin capsule twice a day
- 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 and end of fixed dose phase (Day 63/Week 9)/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 63/Week 9)/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 63/Week 9) (Study Endpoint) compared to baseline.
Change From Baseline in MOS-Sleep Scale, Sleep Problems Index Score at Endpoint Baseline and Day 63 (Week 9)/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.
Change From Baseline in Weekly Mean Pain Score at Weeks 1 to 9 Baseline and weekly from Weeks 1 to 9 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. The overall change is the average change from Weeks 1 to 9.
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.
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 MOS-Sleep Scale, Awaken Short of Breath Score at Endpoint Baseline and Day 63 (Week 9)/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.
Percentage of Participants Who Had Optimal Sleep at Endpoint Day 63 (Week 9)/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.
Clinical Global Impression of Change (CGIC) at Endpoint Day 63 (Week 9)/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).
Change From Baseline in Weekly Mean Sleep Interference Score at Weeks 1 to 9 Baseline and weekly from Weeks 1 to 9 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. The overall change is the average change from Weeks 1 to 9.
Change From Baseline in MOS-Sleep Scale, Snoring Score at Endpoint Baseline and Day 63 (Week 9)/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, Quantity of Sleep Score at Endpoint Baseline and Day 63 (Week 9)/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).
Change From Baseline in MOS-Sleep Scale, Sleep Adequacy Score at Endpoint Baseline and Day 63 (Week 9)/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.
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 Depression Total Score at Endpoint Baseline and Day 63 (Week 9)/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 Mean Sleep Interference Score at Endpoint Baseline and end of fixed dose phase (Day 63/Week 9)/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 9 (Day 63) dose.
Change From Baseline in MOS-Sleep Scale, Sleep Disturbance Score at Endpoint Baseline and Day 63 (Week 9)/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.
Change From Baseline in MOS-Sleep Scale, Somnolence Score at Endpoint Baseline and Day 63 (Week 9)/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.
Patient Global Impression of Change (PGIC) Score at Endpoint Day 63 (Week 9)/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).
Change From Baseline in HADS Anxiety Total Score at Endpoint Baseline and Day 63 (Week 9)/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 Short Form McGill Pain Questionnaire (SF-MPQ) Score at Weeks 1, 5, and 9 Baseline; Weeks 1, 5, and 9 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.
Change From Baseline in Pain VAS From the SF-MPQ at Endpoint Baseline and Day 63 (Week 9)/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 and Day 63 (Week 9)/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).
Baseline Medical Outcomes Study (MOS)-Sleep Scale Scores Baseline The MOS-Sleep Scale was a participant-rated instrument which assesses sleep quantity and quality with 12 items (7 subscale scores: sleep disturbance, snoring, awakening short of breath/with headache, sleep adequacy, somnolence, sleep quantity, optimal sleep; and a 9-item overall sleep problems index). Subscale scores total range: 0-100 (except sleep quantity \[range 0-24 hours\], optimal sleep \[yes:1, no:0\]). Higher scores=poorer sleep outcomes (except sleep quantity, adequacy, and optimal sleep).
Trial Locations
- Locations (30)
Tongren Hospital Affiliated to Capital Medical University
🇨🇳Beijing, China
Southwest hospital of the third military medical university/Department of Neurology
🇨🇳Chongqing, Chongqing, China
Department of Endocrinology, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
🇨🇳Guangzhou, Guangdong, China
Fuzhou General Hospital of Nanjing Military Command
🇨🇳Fuzhou, Fujian, China
Nanfang Hospital, Southern Medical University
🇨🇳Guangzhou, Guangdong, China
The Second Affiliated Hospital of Guangzhou Medical University
🇨🇳Guangzhou, Guangdong, China
Dept. of Endocrinology, The first Affiliated Hospital of Harbin Medical University
🇨🇳Harbin, Heilongjiang, China
Dept. of Endocrinology, The second Affiliated Hospital of Harbin Medical University
🇨🇳Harbin, Heilongjiang, China
Jiangsu Province Hospital
🇨🇳Nanjing, Jiangsu, China
Tongji Hospital,Tongji Medical College Huazhong University of Science & Technology
🇨🇳Wuhan, Hubei, China
The First Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
Xiangya Hospital of Centre-south University
🇨🇳Changsha, Hunan, China
Shengjing hospital of china medical university
🇨🇳Shenyang, Liaoning, China
Dept. of Endocrinology, The second hospital of Jilin University
🇨🇳Changchun, Jilin, China
Qilu Hospital of Shandong University/department of internal neurology
🇨🇳Jinan, Shandong, China
Tianjin Medical University General Hospital
🇨🇳Tianjin, Tianjin, China
Qilu Hospital of Shandong University
🇨🇳Jinan, Shandong, China
Sir Run Run Shaw Hospital, School of medicine, Zhejiang University
🇨🇳Hangzhou, Zhejiang, China
Peking University Third Hospital
🇨🇳Beijing, China
The Second Affiliated Hospital Zhejiang University College of Medicine
🇨🇳Hangzhou, Zhejiang, China
Beijing Tiantan Hospital affiliated to Capital Medical University, Neurology Department
🇨🇳Beijing, China
Endocrinology Department
🇨🇳Beijing, China
Beijing Hospital of the Ministry of Health
🇨🇳Beijing, China
Chinese PLA General Hospital
🇨🇳Beijing, China
GuangZhou First Municipal People's Hospital
🇨🇳Guangzhou, China
Shanghai Changzheng Hospital
🇨🇳Shanghai, China
Huashan Hospital Affiliated Fudan University, Neurology Department
🇨🇳Shang Hai, China
Shanghai Tenth People's Hospital/The Endocrinology Department
🇨🇳Shanghai, China
Shanghai First People's Hospital
🇨🇳Shanghai, China
Renji Hospital Shanghai Jiao Tong University School of Medicine/Neurology Department
🇨🇳Shanghai, China