Efficacy Study Measuring the Impact of Pregabalin on Peripheral Neuropathic Pain.
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00219544
First received: September 13, 2005
Last updated: April 22, 2011
Last verified: April 2011
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Purpose
This study will measure the impact of treatment with pregabalin in adult men and women who have a diagnosis of peripheral neuropathic pain (pain caused by a primary lesion of the peripheral nervous system such as Diabetic peripheral Neuropathy and Postherpetic Neuralgia).
| Condition | Intervention | Phase |
|---|---|---|
|
Neuropathic Pain |
Drug: Pregabalin (Lyrica) Drug: Placebo |
Phase 3 |
| 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: | A Randomized, Placebo-Controlled Trial of the Efficacy and Safety of Pregabalin in the Treatment of Subjects With Peripheral Neuropathic Pain |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Neuropathic Pain in Subjects With Peripheral Neuropathic Pain Conditions During the Double-blind Phase [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]Pain score end of Double-Blind treatment = mean of last 7 available pain scores from daily pain diary while on Double-Blind treatment. A Daily Pain Rating Score : 11- point numerical scale ranging from 0 ("no pain") to 10 ("worst possible pain").
Secondary Outcome Measures:
- Weekly Mean Pain Scores During the Single-blind Treatment Phase [ Time Frame: 0 and 4 weeks ] [ Designated as safety issue: No ]Pain score at Week 0 and Week 4, end of single-bind treatment. Mean of last 7 available pain scores from daily pain diary while on single-blind treatment. A Daily Pain Rating Score : 11- point numerical scale ranging from 0 ("no pain") to 10 ("worst possible pain").
- Weekly Mean Pain Scores During the Double Blind Treatment Phase [ Time Frame: Week 4 - 9 ] [ Designated as safety issue: No ]Mean Pain scores for weeks 4, 5, 6, 7, 8 and 9. Mean of last 7 available pain scores from daily pain diary while on single-blind treatment. A Daily Pain Rating Score : 11-point numerical scale ranging from 0 ("no pain") to 10 ("worst possible pain").
- Change in Pain Scores During Double Blind Treatment Phase [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]Change in Mean Pain score = Mean of last 7 available pain scores from daily pain diary while on single-blind treatment. A Daily Pain Rating Score : 11-point numerical scale ranging from 0 ("no pain") to 10 ("worst possible pain").
- Number of Subjects With >= 30% Reduction in Mean Pain Score During Single-blind Treatment [ Time Frame: Week 4 (end of single-blind treatment phase) ] [ Designated as safety issue: No ]Responders = ≥30% reduction in mean pain score at end of single-blind treatment phase compared to weekly mean pain score at baseline. Mean of last 7 available pain scores from daily pain diary while on single-blind treatment. A Daily Pain Rating Score : 11-point numerical scale ranging from 0 ("no pain") to 10 ("worst possible pain").
- Mean Pain Score for Responders at End of Single-blind Treatment Phase. Change From Baseline of Mean of Last 7 Available Pain Scores From Daily Pain Diary While on Single-blind Treatment. [ Time Frame: Week 4 ] [ Designated as safety issue: No ]Daily Pain Rating Score:11-point numerical scale 0 ("no pain") to 10 ("worst possible pain"). Responders = ≥30% reduction in mean pain score at end of single-blind treatment phase compared to weekly mean pain score at baseline.
- Mean Pain Score for Non-responders at End of Single-blind Treatment Phase [ Time Frame: Week 4 ] [ Designated as safety issue: No ]Change from baseline of mean of last 7 available pain scores from daily pain diary while on single-blind treatment. Daily Pain Rating Score:11-point numerical scale 0 ("no pain") to 10 ("worst possible pain"). Non-Responders = <30% reduction in mean pain score at end of single-blind treatment phase compared to weekly mean pain score at baseline.
- Categorized Daily Pain Score [ Time Frame: Week 9 ] [ Designated as safety issue: No ]Mean number of days in each pain category. DPRS Daily Pain Rating Score Categories: No pain (score 0), Mild pain (scores 1-3), Moderate pain (scores 4-6), Severe pain (scores 7-10)
- Time to Meaningful Increase in Pain During Double-blind Treatment Phase (Number of Participants) [ Time Frame: Week 9 ] [ Designated as safety issue: No ]Number of participants who experienced a meaningful increase in pain also includes participants who took rescue medication for pain due to peripheral neuropathic pain or discontinued from the study .
- Mean Sleep Interference Score [ Time Frame: Week 9 ] [ Designated as safety issue: No ]Mean Sleep Interference (SI) score at end of Double-Blind treatment = mean of last 7 available SI scores from daily SI diary while on Double-Blind treatment. Daily SI rating scale (DSIS) consists of an 11-point numerical scale : Zero means "pain does not interfere with sleep" and 10 means "pain completely interferes with sleep."
- Weekly Mean Sleep Interference Scores During the Single-Blind Treatment Phase [ Time Frame: 0 and 4 weeks ] [ Designated as safety issue: No ]Sleep Interference (SI) score at Week 0 and Week 4, end of single-bind treatment. Mean of last 7 available SI scores from daily SI diary while on single-blind treatment. Daily SI rating scale (DSIS) consists of an 11-point numerical scale : Zero means "pain does not interfere with sleep" and 10 means "pain completely interferes with sleep."
- Weekly Mean Sleep Interference Scores During the Double Blind Treatment Phase [ Time Frame: Week 9 ] [ Designated as safety issue: No ]Mean Sleep Interference scores for weeks 4, 5, 6, 7, 8 and 9. Mean of last 7 available SI scores from daily SI diary while on single-blind treatment. Daily SI rating scale (DSIS) consists of an 11-point numerical scale : Zero means "pain does not interfere with sleep" and 10 means "pain completely interferes with sleep."
- Change in Sleep Interference Scores During Double Blind Treatment Phase [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]Change in Mean SI score: Mean SI score at observation minus mean SI score at week 4. Mean SI Score = mean of last 7 available SI scores from daily SI diary while on single-blind treatment. Daily SI rating scale (DSIS) is 11-point numerical scale : Zero means "pain does not interfere with sleep" and 10 means "pain completely interferes with sleep."
- Intensity of Neuropathic Pain -Visual Analog Scale (NeP - VAS) [ Time Frame: Week 4, Week 9 ] [ Designated as safety issue: No ]Change in Scale from randomization to Week 9. Scale to measure Neuropathic Pain -Visual Analog Scale (NeP - VAS): the subject places a mark on the VAS scale (0 to 100) where 0 represents the worst imaginable health state and 100 represents the best imaginable health state.
- Change in Hospital Anxiety and Depression Scale Responses [ Time Frame: Week 9 ] [ Designated as safety issue: No ]Mean Change from Randomization in Score from Hospital Anxiety and Depression Scale (HADS): 2 subscales, measuring anxiety (HADS-A)and depression (HADS-D). 7 items in each subscale assessed on a scale of 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). which yields the score ranging 0-21.
- Change in Pain Treatment Satisfaction Scale (PTSS) [ Time Frame: Week 9 ] [ Designated as safety issue: No ]
Mean Change: score from observation minus score from randomization: PTSS "Impact" module of 8-items & "Satisfaction" module of 6-items; item scores 1-5.
Mean score for each module transformed onto scale 0- 100, where score 0 =worst possible response and score 100
=best possible response: Score =[(5 - mean non-missing items)*100]/4.
- Patient Global Impression of Change (PGIC) Categories by Number of Subjects [ Time Frame: Week 9 ] [ Designated as safety issue: No ]
Number of subjects that responded to PGIC Categories. PGIC is a subject-rated instrument that measures change in the subject's overall status on a 7-point scale. Scores range from
1 (very much improved) to 7 (very much worse).
- Change in Modified Brief Pain Inventory (mBPI) for Pain Interference or Pain Severity. [ Time Frame: Week 9 ] [ Designated as safety issue: No ]Mean Change from Randomization: score at mBPI observation minus score at randomization. mBPI is extent to which pain interferes with daily activities on a 0 (no interference) to 10 (completely interfered) scale.
- Change in Euro Quality of Life (EQ-5D) Health State Profile and Visual Analog Scale Components [ Time Frame: Week 9 ] [ Designated as safety issue: No ]two components to the EQ-5D: a Health State Profile (scores from five domains are used to calculate the utility score :0 refers to dead and a score of 1 refers to perfect health) and a Visual Analogue Scale (VAS) (0 represents the worst imaginable health state and 100 represents the best imaginable health state)
| Enrollment: | 158 |
| Study Start Date: | November 2005 |
| Study Completion Date: | February 2008 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: Pregabalin (Lyrica)
pregabalin 150mg/day (75mg BID)
|
| Experimental: 2 |
Drug: Pregabalin (Lyrica)
pregabalin 300 mg/day (150mg BID)
|
| Experimental: 3 |
Drug: Pregabalin (Lyrica)
pregabalin 600/day (300mg BID)
|
| Placebo Comparator: 4 |
Drug: Placebo
Placebo
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subjects presenting a diagnosis of peripheral neuropathic pain, defined as pain caused by a lesion of the peripheral nervous system manifesting with sensory symptoms and signs, for at least 6 months at screening.
- At baseline, subjects must have completed at least 4 daily pain diaries and must have a mean weekly pain score equal or greater than 4.
Exclusion Criteria:
- Presence of any of the following diagnoses: Cervical or lumbo-sacral radiculopathy; Operated or non-operated chronic low back pain Carpal tunnel syndrome or any other entrapment-related neuropathic pain (defined as pain associated with focal nerve lesion produced by constriction or mechanical distortion of the nerve, within a fibrous or fibro-osseous tunnel, or by a fibrous band) ; Complex regional pain syndrome (type 1 and 2); Fibromyalgia.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00219544
Locations
| Canada, Alberta | |
| Pfizer Investigational Site | |
| Calgary, Alberta, Canada, T2N 4N1 | |
| Pfizer Investigational Site | |
| Calgary, Alberta, Canada, T3B 0M3 | |
| Pfizer Investigational Site | |
| Calgary, Alberta, Canada, T2S 3C3 | |
| Pfizer Investigational Site | |
| Edmonton, Alberta, Canada, T5N 3Y6 | |
| Pfizer Investigational Site | |
| Edmonton, Alberta, Canada, T5J 3N4 | |
| Pfizer Investigational Site | |
| Red Deer, Alberta, Canada, T4N 6V7 | |
| Canada, British Columbia | |
| Pfizer Investigational Site | |
| Kelowna, British Columbia, Canada, V1Y 2H4 | |
| Pfizer Investigational Site | |
| Vancouver, British Columbia, Canada, V6Z 2E8 | |
| Pfizer Investigational Site | |
| Vancouver, British Columbia, Canada, V6E 1M7 | |
| Canada, Manitoba | |
| Pfizer Investigational Site | |
| Winnipeg, Manitoba, Canada, R2V 4W3 | |
| Pfizer Investigational Site | |
| Winnipeg, Manitoba, Canada, R3E 3P4 | |
| Pfizer Investigational Site | |
| Winnipeg, Manitoba, Canada, R3A 1R9 | |
| Canada, Nova Scotia | |
| Pfizer Investigational Site | |
| Halifax, Nova Scotia, Canada, B3J 3T1 | |
| Canada, Ontario | |
| Pfizer Investigational Site | |
| Kingston, Ontario, Canada, K7L 2V7 | |
| Pfizer Investigational Site | |
| London, Ontario, Canada, N6A 4V2 | |
| Pfizer Investigational Site | |
| Port Hope, Ontario, Canada, L1A 3Y9 | |
| Pfizer Investigational Site | |
| Toronto, Ontario, Canada, M5G 2N2 | |
| Canada, Prince Edward Island | |
| Pfizer Investigational Site | |
| Charlottetown, Prince Edward Island, Canada, C1E 1J7 | |
| Canada, Quebec | |
| Pfizer Investigational Site | |
| Granby, Quebec, Canada, J2G 8Z9 | |
| Pfizer Investigational Site | |
| Laval, Quebec, Canada, H7T 2P5 | |
| Pfizer Investigational Site | |
| Laval, Quebec, Canada, H7M 3L9 | |
| Pfizer Investigational Site | |
| Levis, Quebec, Canada, G6V 3Z1 | |
| Pfizer Investigational Site | |
| Mirabel, Quebec, Canada, J7J 2K8 | |
| Pfizer Investigational Site | |
| Montreal, Quebec, Canada, H3T 1E2 | |
| Pfizer Investigational Site | |
| Montreal, Quebec, Canada, H3A 2B4 | |
| Pfizer Investigational Site | |
| Montreal, Quebec, Canada, H3G 1A4 | |
| Pfizer Investigational Site | |
| Sherbrook, Quebec, Canada, J1H 4J6 | |
| Pfizer Investigational Site | |
| Sherbrooke, Quebec, Canada, J1H 5N4 | |
| Pfizer Investigational Site | |
| Ste-Foy, Quebec, Canada, G1V 4X7 | |
| Canada, Saskatchewan | |
| Pfizer Investigational Site | |
| Saskatoon, Saskatchewan, Canada, S7N 0W8 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trials Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT00219544 History of Changes |
| Other Study ID Numbers: | A0081084 |
| Study First Received: | September 13, 2005 |
| Results First Received: | February 13, 2009 |
| Last Updated: | April 22, 2011 |
| Health Authority: | Canada: Health Canada |
Additional relevant MeSH terms:
|
Neuralgia Pain Neurologic Manifestations Nervous System Diseases Peripheral Nervous System Diseases Neuromuscular Diseases Signs and Symptoms Pregabalin |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anticonvulsants |
ClinicalTrials.gov processed this record on May 16, 2013