A Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42160443 in Patients With Neuro… (NCT00964990) | Clinical Trial Compass
TerminatedPhase 2
A Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42160443 in Patients With Neuropathic Pain (Postherpetic Neuralgia and Post-traumatic Neuralgia)
Stopped: Logistic reasons associated with the FDA-imposed clinical hold.
United States112 participantsStarted 2009-09
Plain-language summary
The purpose of this study is to evaluate the safety and effectiveness of JNJ-42160443 in the treatment of moderate to severe neuropathic pain in patients with a diagnosis of postherpetic neuralgia and post-traumatic neuralgia.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion Criteria:
Patients diagnosed with postherpetic neuralgia or post-traumatic neuralgia and who have chronic neuropathic pain (pain persistent for \> 6 months) that is moderate to severe; Currently taking pain medication but are not adequately controlled by standard of care or are not currently taking pain medications because intolerable to, or not willing to use, standard of care. Exclusion Criteria: History of a separate pain condition (e.g., joint osteoarthritis) that is more severe than pain due to diagnosis of PHN or post-traumatic neuralgia
* Patients with post-traumatic neuralgia that are characteristic of complex regional pain syndrome Type I
* Patients with lumbar-sacral radiculopathy, failed low-back surgery, or spinal cord injury
* Patient whose nerve injury or pain is expected to recover in the next 4 months
* Patients with evidence of another neuropathic pain not under study, such as pain resulting from diabetic painful neuropathy, sensory neuropathies or pain caused by radiation, chemotherapy, alcohol, HIV infection
* Other peripheral neuropathy, paresthesia, or dysesthesia, or any other previously diagnosed neurologic condition causing the above noted symptoms that is not related with the PHN or post-traumatic neuralgia under the study
* Women who are pregnantHistory of a separate pain condition (e.g., joint osteoarthritis) that is more severe than pain due to diagnosis of PHN or post-traumatic neuralgia; Patients with post-traumatic neuralgia that are…
What they're measuring
1
The daily evening assessment of average pain intensity
Timeframe: Baseline (7 days before randomization) and last 7 days of the 12-week treatment phase
Trial details
NCT IDNCT00964990
SponsorJohnson & Johnson Pharmaceutical Research & Development, L.L.C.