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

Neuropathic Pain Clinical Trial

Official title:

A Randomized, Placebo-Controlled Trial of the Efficacy and Safety of Pregabalin in the Treatment of Subjects With Peripheral Neuropathic Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00219544
• Other study ID #: A0081084
• Status: Completed
• Phase: Phase 3
• Start date: November 2005
• Est. completion date: February 2008

Study information

• Verified date: November 2018
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain

Intervention

Drug:
• Pregabalin (Lyrica)
pregabalin 150mg/day (75mg BID)
• Pregabalin (Lyrica)
pregabalin 300 mg/day (150mg BID)
• Pregabalin (Lyrica)
pregabalin 600/day (300mg BID)
• Placebo
Placebo

Locations

Country	Name	City	State
Canada	Pfizer Investigational Site	Calgary	Alberta
Canada	Pfizer Investigational Site	Calgary	Alberta
Canada	Pfizer Investigational Site	Calgary	Alberta
Canada	Pfizer Investigational Site	Charlottetown	Prince Edward Island
Canada	Pfizer Investigational Site	Edmonton	Alberta
Canada	Pfizer Investigational Site	Edmonton	Alberta
Canada	Pfizer Investigational Site	Granby	Quebec
Canada	Pfizer Investigational Site	Halifax	Nova Scotia
Canada	Pfizer Investigational Site	Kelowna	British Columbia
Canada	Pfizer Investigational Site	Kingston	Ontario
Canada	Pfizer Investigational Site	Laval	Quebec
Canada	Pfizer Investigational Site	Laval	Quebec
Canada	Pfizer Investigational Site	Levis	Quebec
Canada	Pfizer Investigational Site	London	Ontario
Canada	Pfizer Investigational Site	Mirabel	Quebec
Canada	Pfizer Investigational Site	Montreal	Quebec
Canada	Pfizer Investigational Site	Montreal	Quebec
Canada	Pfizer Investigational Site	Montreal	Quebec
Canada	Pfizer Investigational Site	Port Hope	Ontario
Canada	Pfizer Investigational Site	Red Deer	Alberta
Canada	Pfizer Investigational Site	Saskatoon	Saskatchewan
Canada	Pfizer Investigational Site	Sherbrook	Quebec
Canada	Pfizer Investigational Site	Sherbrooke	Quebec
Canada	Pfizer Investigational Site	Ste-Foy	Quebec
Canada	Pfizer Investigational Site	Toronto	Ontario
Canada	Pfizer Investigational Site	Vancouver	British Columbia
Canada	Pfizer Investigational Site	Vancouver	British Columbia
Canada	Pfizer Investigational Site	Winnipeg	Manitoba
Canada	Pfizer Investigational Site	Winnipeg	Manitoba
Canada	Pfizer Investigational Site	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neuropathic Pain in Subjects With Peripheral Neuropathic Pain Conditions During the Double-blind Phase	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").	9 weeks
Secondary	Weekly Mean Pain Scores During the Single-blind Treatment Phase	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").	0 and 4 weeks
Secondary	Weekly Mean Pain Scores During the Double Blind Treatment Phase	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").	Week 4 - 9
Secondary	Change in Pain Scores During Double Blind Treatment Phase	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").	9 weeks
Secondary	Number of Subjects With >= 30% Reduction in Mean Pain Score During Single-blind Treatment	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").	Week 4 (end of single-blind treatment phase)
Secondary	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.	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.	Week 4
Secondary	Mean Pain Score for Non-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. 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.	Week 4
Secondary	Categorized Daily Pain Score	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)	Week 9
Secondary	Time to Meaningful Increase in Pain During Double-blind Treatment Phase (Number of Participants)	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 .	Week 9
Secondary	Mean Sleep Interference Score	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."	Week 9
Secondary	Weekly Mean Sleep Interference Scores During the Single-Blind Treatment Phase	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."	0 and 4 weeks
Secondary	Weekly Mean Sleep Interference Scores During the Double Blind Treatment Phase	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."	Week 9
Secondary	Change in Sleep Interference Scores During Double Blind Treatment Phase	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."	9 weeks
Secondary	Intensity of Neuropathic Pain -Visual Analog Scale (NeP - VAS)	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.	Week 4, Week 9
Secondary	Change in Hospital Anxiety and Depression Scale Responses	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.	Week 9
Secondary	Change in Pain Treatment Satisfaction Scale (PTSS)	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.	Week 9
Secondary	Patient Global Impression of Change (PGIC) Categories by Number of Subjects	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).	Week 9
Secondary	Change in Modified Brief Pain Inventory (mBPI) for Pain Interference or Pain Severity.	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.	Week 9
Secondary	Change in Euro Quality of Life (EQ-5D) Health State Profile and Visual Analog Scale Components	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)	Week 9

External Links

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