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Study of FLEXISEQ® for Treatment of Osteoarthritis of the Knee in NSAID-compromised Patients

NCT02594176 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2016-02-03

No results posted yet for this study

Summary

Primary Objective To substantiate the efficacy of 2.2 g FLEXISEQ® for the treatment of pain related to osteoarthritis (OA) of the knee in patients contraindicated for or with clinical intolerance to NSAIDs.

Secondary Objectives

* To substantiate the efficacy of 2.2 g FLEXISEQ® for the treatment of stiffness and improvement of joint function in patients contraindicated for or with clinical intolerance to NSAIDs and with OA of the knee.
* To substantiate safety and tolerability of 2.2 g FLEXISEQ® in patients contraindicated for or with clinical intolerance to NSAIDs and with OA of the knee.

Conditions

Interventions

DEVICE

FLEXISEQ®

applicable gel

DEVICE

Placebo

applicable gel

Sponsors & Collaborators

  • International Medical Research - Partner GmbH

    collaborator OTHER

  • Pro Bono Bio

    lead INDUSTRY

Principal Investigators

  • Matthias Rother, MD · International Medical Research - Partner GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2016-03-31
Completion
2016-10-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

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 NCT02594176 on ClinicalTrials.gov