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A Study to Investigate the Safety and Effectiveness of Different Doses of Sprifermin in Participants With Osteoarthritis of the Knee

NCT01919164 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 549

Last updated 2020-07-13

Study results available
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Summary

This was a multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase 2 trial of Sprifermin administered intra-articularly in participants with primary osteoarthritis of the knee and Kellgren-Lawrence Grade 2 or 3. The trial was intended to investigate the efficacy and safety of different intra articular dosages of Sprifermin in these individuals.

Conditions

  • Osteoarthritis, Knee

Interventions

DRUG

Sprifermin

Participants received Sprifermin as intra-articular injection.

DRUG

Placebo

Participants received Placebo matched to sprifermin as intra-articular injection.

Sponsors & Collaborators

  • Nordic Bioscience A/S

    collaborator INDUSTRY

  • EMD Serono Research & Development Institute, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Responsible, MD · Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-29
Primary Completion
2016-05-05
Completion
2019-05-07

Countries

  • United States
  • Argentina
  • Czechia
  • Denmark
  • Estonia
  • Hong Kong
  • Poland
  • Romania

Study Locations

More Related Trials

Entities

Drugs

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 NCT01919164 on ClinicalTrials.gov