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Study of Safety, Efficacy of Fulranumab Adjunctive Use in OA of Hip or Knee, PAI3007

NCT02301234 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 111

Last updated 2017-09-14

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 signs and symptoms of osteoarthritis of the hip or knee that are not adequately controlled by current pain therapy.

Conditions

Interventions

DRUG

Placebo

Placebo will be administered once every 4 weeks with or without adjunctive therapy 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 with or without adjunctive therapy 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 with or without adjunctive therapy for up to 16 weeks by SC injection into the thigh or abdomen.

DRUG

Celecoxib 100 mg

Double-blind capsules taken twice daily for up to 16 weeks.

DRUG

Celecoxib 100 mg Matching Placebo

Double-blind capsules taken twice daily for up to 16 weeks.

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
2015-03-25
Primary Completion
2016-09-19
Completion
2016-09-19

Countries

  • United States
  • Australia
  • Canada
  • Czechia
  • Germany
  • Hungary
  • Poland
  • South Korea
  • Spain
  • Sweden
  • 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 NCT02301234 on ClinicalTrials.gov