Phase 1
Completed N=25
A Study To Assess The Ability Of A Crossover Study Design To Detect The Efficacy Of Pregabalin In Post-Traumatic Neuropathic Pain Patients
Nerve Pain
Source: ClinicalTrials.gov NCT00654940 ↗
Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Feb 2010
Primary outcomePrimary: Change From Baseline to Treatment Week 2 in Daily Pain Rating Scale — 6.03; 5.24; 5.96; 5.31 scores on scale
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Treatment Week 2 in Daily Pain Rating Scale |
6.03; 5.24; 5.96; 5.31; 5.40; 5.08 | — |
| SECONDARY Neuropathic Pain Symptom Inventory (NPSI) |
5.31; 5.25; 5.31; 4.91; 4.33; 5.27 | — |
| SECONDARY Subject Activity as Captured by the Actiwatch Score Device: Total Activity Score at End of Treatment |
300000; 270000 | — |
Eligibility Criteria
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 ≥ 4.
- 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.
Data sourced from ClinicalTrials.gov (NCT00654940). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.