RN624 In Adult Patients With Chronic Low Back Pain

NCT00584870 | Completed Phase 2 Results

• 2 other identifiers: A4091004CLBP POC
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 38

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 6

  Daily average low back pain was assessed on an 11-point numeric rating scale (NRS). Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain). Baseline value was calculated as mean of the scores over 5-day prior to randomization (initial pain assessment period). Post-baseline weekly scores were calculated based on the mean of the scores over the 7 days prior to and including the day at the end of the corresponding week.

  Baseline, Week 6

Secondary Outcomes (19)

• Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 1, 2, 4, 8 and 12

  Baseline, Week 1, 2, 4, 8, 12

• Change From Baseline in Average Low Back Pain Intensity (LBPI) Score Over Weeks 1 to 4, 1 to 8, 1 to 12, 5 to 8, and 5 to 12

  Baseline, Weeks 1 to 4, 1 to 8, 1 to 12, 5 to 8, 5 to 12

• Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Worst Pain and Average Pain at Week 1, 2, 4, 6, 8 and 12

  Baseline, Week 1, 2, 4, 6, 8, 12

• Number of Participants With Average Low Back Pain Intensity (LBPI) Score of 2 or Less

  Week 1, 2, 4, 6, 8, 12

• Number of Participants With Cumulative Percent (%) Reduction From Baseline in Average Low Back Pain Intensity (LBPI) Score at Week 6

  Week 6

Other Outcomes (2)

• Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)

  Baseline up to 28 days after last dose of study treatment (up to Week 16)

• Number of Participants With Anti-Drug Antibody (ADA)

  Baseline up to Week 12

Study Arms (3)

Naproxen

ACTIVE COMPARATOR

Drug: Naproxen

Placebo

PLACEBO COMPARATOR

Drug: Placebo

RN624

EXPERIMENTAL

Drug: PF-04383119 (RN624)

Interventions

Naproxen DRUG

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

Naproxen

Placebo DRUG

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

Placebo

PF-04383119 (RN624) DRUG

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

RN624

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female of any race, \>18 years of age and have BMI ≤39 kg/m2
• Present with duration of chronic low back pain of ≥3 months requiring regular use of analgesic medication (\>4 days per week for the past month)
• Primary location of low back pain is between the 12th thoracic vertebra and the lower gluteal folds, with or without radiation into the posterior thigh, classified as Category 1 or 2 according to the classification of the Quebec Task Force in Spinal Disorders
• Must have a score of ≥4 for Low Back Pain Intensity (NRS) while on current treatment at Screening, and completes at least 4 daily pain diaries during the 5 days prior to Randomization, with an average Low Back Pain Intensity (NRS) score of ≥4

You may not qualify if:

• Back pain due to visceral disorder (i.e. endometriosis) or Back pain due to recent major trauma (i.e. vertebral fracture, post-traumatic spondylolisthesis)
• History of lumbosacral radiculopathy, spinal stenosis associated with neurological impairment, or neurogenic claudication
• Osteoporotic compression fracture within the last 6 months
• Known history of: Rheumatoid arthritis; Seronegative spondyloarthropathy (i.e., ankylosing spondylitis, psoriatic arthritis, reactive arthritis, inflammatory bowel disease-related arthropathy); Paget's disease of spine, pelvis or femur; Fibromyalgia; Tumors or infections of the spinal cord
• Patients receiving acetaminophen only to manage their chronic low back pain
• Any uncontrolled or untreated chronic disease

Sponsors & Collaborators

• Pfizer: lead

Study Sites (38)

Pinnacle Research Group LLC

Anniston, Alabama, 36207, United States

Location

Radiant Research

Birmingham, Alabama, 35209, United States

Location

Radiant Research - Phoenix Southeast

Chandler, Arizona, 85225, United States

Location

Radiant Research

Scottsdale, Arizona, 85251, United States

Location

Advanced Clinical Research Institute

Anaheim, California, 92801, United States

Location

University of California San Diego

San Diego, California, 92121, United States

Location

Doctors Medical Center of Walton County

DeFuniak Springs, Florida, 32435, United States

Location

SJS Clinical Research, Inc.

Destin, Florida, 32541, United States

Location

Adult Medicine Specialists

Longwood, Florida, 32779, United States

Location

Genesis Research International

Longwood, Florida, 32779, United States

Location

Collier Neurologic Specialists

Naples, Florida, 34102, United States

Location

Cotton-O'Neil Clinical Research

Topeka, Kansas, 66606, United States

Location

Cotton-O'Neil Clinic

Topeka, Kansas, 66606, United States

Location

Heartland Research Associates

Wichita, Kansas, 67207, United States

Location

Northeast Medical Research Associates, Inc

North Dartmouth, Massachusetts, 02747, United States

Location

Clinical Pharmacology Study Group

Worcester, Massachusetts, 01610, United States

Location

Spence Medical Research

Picayune, Mississippi, 39466, United States

Location

Radiant Research, Inc.

St Louis, Missouri, 63141, United States

Location

Quality Clinical Research, Inc.

Omaha, Nebraska, 68114, United States

Location

The Medical Research Network, LLC

New York, New York, 10024, United States

Location

North State Clinical Research, PLLC

Lenoir, North Carolina, 28645, United States

Location

Wake Internal Medicine Consultants, Inc.

Raleigh, North Carolina, 27612, United States

Location

Wake Research Associates

Raleigh, North Carolina, 27612, United States

Location

Summit Research Network (Oregon), Inc.

Portland, Oregon, 97210, United States

Location

Allegheny Pain Management

Altoona, Pennsylvania, 16602, United States

Location

New England Center for Clinical Research

Cranston, Rhode Island, 02920, United States

Location

Partners in Clinical Research

Cumberland, Rhode Island, 02864, United States

Location

Omega Medical Research

Warwick, Rhode Island, 02886, United States

Location

Radiant Research

Greer, South Carolina, 29651, United States

Location

Advanced Therapeutics, Inc.

Johnson City, Tennessee, 37601, United States

Location

Johnson City Internal Medicine

Johnson City, Tennessee, 37601, United States

Location

DiscoveResearch, Incorporated

Bryan, Texas, 77802, United States

Location

Advances In Health, Inc.

Houston, Texas, 77030, United States

Location

Centex Research

Nassau Bay, Texas, 77058, United States

Location

Immediate Medical Care

Nassau Bay, Texas, 77058, United States

Location

Radiant Research San Antonio

San Antonio, Texas, 78229, United States

Location

Independence Family Medicine

Virginia Beach, Virginia, 23455, United States

Location

Summit Research Network (Seattle) LLC

Seattle, Washington, 98104, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Low Back Pain

Interventions

Naproxen; tanezumab

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: January 2, 2008
• Study Start: July 5, 2007
• Primary Completion: September 2, 2008
• Study Completion: September 2, 2008
• Last Updated: July 12, 2021
• Results First Posted: June 16, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share

Locations

US (38)