Methodology Study To Assess The Ability Of A Randomized, Double-Blind, Placebo-Controlled, Two Period Crossover Study To Detect The Effect Of Pregabalin In Post-Traumatic Neuropathic Pain Patients
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Change From Baseline to Treatment Week 2 in Daily Pain Rating Scale
Study Overview
Brief Summary
The purpose of this study is to assess whether a cross-over type study design in post-traumatic neuropathic patients can be used to assess the activity of potential analgesic agents
Detailed Description
Methodology study to evaluate a cross-over study design in post-traumatic neuropathic pain patients.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients require a diagnosis of post-traumatic peripheral neuropathic pain (NeP), including post-surgical NeP and NeP due to peripheral nerve injury, which has lasted at least 3 months following the traumatic event.
- •Patients during the screening week must have completed ≥ 4 daily pain scores and have an average daily pain score ≥
- •Female patients of childbearing potential must have a negative urine pregnancy test at Screening and be practicing an acceptable form of contraception.
Exclusion Criteria
- •Patients with neuropathic pain (NeP) that is not due to trauma; e.g. patients with trigeminal neuralgia, central pain, complex region pain syndrome type I, phantom limb pain, radiculopathy, painful diabetic neuropathy or post-herpetic neuralgia or patients with any other co-existing pain which cannot be differentiate from NeP of peripheral origin.
- •Patients who have previously failed to respond to pregabalin at a total daily dose of equal to or greater than 300 mg or are intolerant to those doses.
- •Patients who have previously failed to respond to gabapentin at a total daily dose of equal to or greater than 1800 mg.
- •Patients with any type or history of malignancy, except either where there has been no ongoing treatment for at least 6 months or all basal cell carcinomas; all patients with a history of brain or spinal tumors will be excluded.
- •Patients who currently have ongoing litigation related to any injury affecting their pain symptomatology.
Arms & Interventions
A
Intervention: Pregabalin (Lyrica) (Drug)
B
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Change From Baseline to Treatment Week 2 in Daily Pain Rating Scale
Time Frame: Week 0 to Week 2, Week 4 to Week 6 (Baseline to Week 2 [End of Treatment] for each treatment period)
Daily Pain Rating Scale by treatment and sequence using an 11-point Likert scale: range 0 (no pain) to 10 (worst possible pain) over the past 24 hours. Self-assessment was performed daily on rising from bed (for the final time in the case of interrupted sleep). Average daily pain score: mean of the previous 7 days daily pain scores. Baseline was defined as the mean of the last 7 pre-treatment pain scores for each period. End of treatment was defined as the mean of the last 7 on treatment pain scores for each period.
Secondary Outcomes
- Neuropathic Pain Symptom Inventory (NPSI)(Week 0 to Week 2, Week 4 to Week 6 (Baseline to End of Treatment in Treatment Periods 1 and 2))
- Subject Activity as Captured by the Actiwatch Score Device: Total Activity Score at End of Treatment(Week 0 to Week 2, Week 4 to Week 6 (Baseline to End of Treatment in Treatment Periods 1 and 2))