A Study To Assess The Ability Of A Crossover Study Design To Detect The Efficacy Of Pregabalin In Post-Traumatic Neuropathic Pain Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00654940
• Date of registration: 03/04/2008
• Prospective Registration: Yes
• Primary sponsor: Pfizer
• Public title: A Study To Assess The Ability Of A Crossover Study Design To Detect The Efficacy Of Pregabalin In Post-Traumatic Neuropathic Pain Patients
• Scientific title: 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
• Date of first enrolment: May 2008
• Target sample size: 25
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00654940
• Study type: Interventional
• Phase: Phase 1

Countries of recruitment

Canada, Sweden

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Nerve Pain

Intervention(s)

Drug: Pregabalin (Lyrica)

Drug: Placebo

Primary Outcome(s)

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)]

Secondary Outcome(s)

Neuropathic Pain Symptom Inventory (NPSI) [Time Frame: 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 [Time Frame: Week 0 to Week 2, Week 4 to Week 6 (Baseline to End of Treatment in Treatment Periods 1 and 2)]

Secondary ID(s)

A0081187

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 24/02/2010
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00654940