At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 220 enrolled
Drug / intervention
Naproxen +2 moredrug
Likely dose
Naproxen 500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
PHASE II RANDOMIZED, DOUBLE-BLIND, PLACEBO-AND ACTIVE CONTROLLED, MULTICENTER, PARALLEL GROUP PROOF OF CONCEPT STUDY OF THE ANALGESIC EFFECTS OF RN624 IN ADULT PATIENTS WITH CHRONIC LOW BACK PAIN
In Brief
A Phase 2 clinical trial evaluating Naproxen, Placebo, and 1 other intervention for Low Back Pain. Completed, enrolled 220 participants across 38 sites.
Detailed Summary
The primary objective of this study is to evaluate the analgesic efficacy of RN624 compared with placebo and compared with naproxen in the treatment of adult patients with chronic low back pain.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLow Back Pain
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2007
First PostedJan 2008
Primary CompletionSep 2008
TodayJul 2026
First PostedJan 2, 2008
Enrollment StartJul 5, 2007
Primary CompletionSep 2, 2008
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 18.5 years ago
Interventions
Naproxendrug
Oral naproxen 500 mg twice daily for Weeks 1-12.
Placebodrug
Single IV infusion of placebo on Day 1 and placebo for naproxen twice daily for Weeks 1-12.
PF-04383119 (RN624)drug
Single IV infusion of 200 micrograms/kg RN624 on Day 1