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Study of Efficacy, Safety of Fulranumab Adjunctive Use in OA of Hip or Knee, PAI3001

NCT02336685 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2017-10-02

No results posted yet for this study

Summary

The purpose of this study is to demonstrate the efficacy, safety, and tolerability of fulranumab as adjunctive therapy compared with placebo in participants with chronic moderate to severe pain and functional impairment from knee or hip osteoarthritis that is not adequately controlled by current pain therapy.

Conditions

Interventions

DRUG

Placebo

Placebo will be administered once every 4 weeks for 16 weeks by subcutaneous (SC) injection (injection under the skin) into the thigh or abdomen.

DRUG

Fulranumab 1 mg

Fulranumab will be administered once every 4 weeks for up to 16 weeks by SC injection into the thigh or abdomen.

DRUG

Fulranumab 3 mg

Fulranumab will be administered once every 4 weeks for up to 16 weeks by SC injection into the thigh or abdomen.

DRUG

Opioid

Opioids will be administered as standard of care for osteoarthritis (OA) pain therapy during the double-blind treatment phase as per investigator discretion.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-07-07
Primary Completion
2016-09-16
Completion
2016-09-16
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Hungary
  • New Zealand
  • Poland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT02336685 on ClinicalTrials.gov