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

Phase 3

Completed

• Conditions: Neuropathic Pain
• Interventions: Drug: Pregabalin (Lyrica); Drug: Placebo

• Registration Number: NCT00219544
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-22
• Study Start: 2005-11
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Results First Submitted: 2009-02-13
• Results First Submitted QC: 2009-04-07
• Results First Posted: 2009-06-02
• Status Verified: 2018-11
• Last Update Submitted: 2021-01-20
• Last Update Posted: 2021-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 158

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Pregabalin (Lyrica)	-
2	Pregabalin (Lyrica)	-
3	Pregabalin (Lyrica)	-
4	Placebo	-

Primary Outcome Measures

Name	Time	Method
Neuropathic Pain in Subjects With Peripheral Neuropathic Pain Conditions During the Double-blind Phase	9 weeks	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

Name	Time	Method
Weekly Mean Sleep Interference Scores During the Double Blind Treatment Phase	Week 9	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."
Weekly Mean Pain Scores During the Double Blind Treatment Phase	Week 4 - 9	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	9 weeks	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").
Mean Sleep Interference Score	Week 9	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."
Number of Subjects With >= 30% Reduction in Mean Pain Score During Single-blind Treatment	Week 4 (end of single-blind treatment phase)	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 Non-responders at End of Single-blind Treatment Phase	Week 4	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	Week 9	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)
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.	Week 4	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.
Time to Meaningful Increase in Pain During Double-blind Treatment Phase (Number of Participants)	Week 9	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 .
Weekly Mean Pain Scores During the Single-blind Treatment Phase	0 and 4 weeks	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 Sleep Interference Scores During the Single-Blind Treatment Phase	0 and 4 weeks	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."
Change in Sleep Interference Scores During Double Blind Treatment Phase	9 weeks	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)	Week 4, Week 9	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	Week 9	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)	Week 9	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	Week 9	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.	Week 9	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	Week 9	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)

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇨🇦 Saskatoon, Saskatchewan, Canada