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RN624 In Adult Patients With Chronic Low Back Pain

NCT00584870 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2021-07-12

Study results available
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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.

Conditions

  • Low Back Pain

Interventions

DRUG

Naproxen

Oral naproxen 500 mg twice daily for Weeks 1-12.

DRUG

Placebo

Single IV infusion of placebo on Day 1 and placebo for naproxen twice daily for Weeks 1-12.

DRUG

PF-04383119 (RN624)

Single IV infusion of 200 micrograms/kg RN624 on Day 1

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-05
Primary Completion
2008-09-02
Completion
2008-09-02

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00584870 on ClinicalTrials.gov