A Dose-ranging Study of the Safety and Effectiveness of JNJ-42160443 as add-on Treatment in Patients With Low Back Pain
TerminatedPhase 2NCT00973024
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Brief summary (from the registry)
The purpose of this study is to compare the safety and effectiveness of different doses of JNJ-42160443 with placebo in the treatment of chronic, moderate to severe low back pain patients with a diagnosis of chronic low back pain.
Study details
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Dose-Loading Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42160443 as Adjunctive Therapy in Subjects With Inadequately Controlled, Moderate to Severe, Chronic Low Back Pain
- Conditions
- Interventions
- Drug: JNJ-42160443 3 mg
- Drug: JNJ-42160443 1 mg
- Drug: JNJ-42160443 6 mg/3mg
- Drug: JNJ-42160443 10 mg
- Drug: Matching Placebo
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Start date
- 2009-09
- Primary completion
- 2011-05
- Sex
- All
- Age range
- from 18 Years to 80 Years
- Results posted
- No results posted in this snapshot
- Countries
- Belgium, Canada, Netherlands, United States
- Total sites listed
- 60
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Diagnosis of chronic low back pain Exclusion Criteria: * Pain with radiation to the extremity and with neurologic signs * history within the past year of any of the following: seizure disorder * intrathecal therapy and ventricular shunts, mild or moderate traumatic brain injury, stroke, or transient ischemic attack, meningitis * History of brain injury within the past 15 years consisting of \>= 1 of the following, or with residual sequalae suggesting transient changes in consciousness: brain contusion, intracranial hematoma, either unconsciousness or posttraumatic amnesia lasting more than 24 hours * History of epilepsy or multiple sclerosis * Current diagnosis of fibromyalgia, complex regional pain syndrome (including reflex sympathetic dystrophy or causalgia), acute spinal cord compression, bowel or bladder dysfunction as a result of cauda equine compression, back pain caused by secondary infection, or pain caused by confirmed or suspected neoplasm * Any new or unresolved neurologic deficits, including progressive deficits, within 6 months before screening
Canadian sites (15)
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00973024