Efficacy Study Measuring the Impact of Pregabalin on Peripheral Neuropathic Pain.

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00219544
First received: September 13, 2005
Last updated: April 22, 2011
Last verified: April 2011
  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
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: 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, R3E 3P4
Pfizer Investigational Site
Winnipeg, Manitoba, Canada, R2V 4W3
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, H7M 3L9
Pfizer Investigational Site
Laval, Quebec, Canada, H7T 2P5
Pfizer Investigational Site
Levis, Quebec, Canada, G6V 3Z1
Pfizer Investigational Site
Mirabel, Quebec, Canada, J7J 2K8
Pfizer Investigational Site
Montreal, Quebec, Canada, H3G 1A4
Pfizer Investigational Site
Montreal, Quebec, Canada, H3A 2B4
Pfizer Investigational Site
Montreal, Quebec, Canada, H3T 1E2
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
Gamma-Aminobutyric Acid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
GABA Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on October 19, 2014