Who is sponsoring NCT01209364?

NCT01209364 is sponsored by Galderma R&D.

What drugs are being tested in NCT01209364?

Interventions in NCT01209364: Durolane is a device, methylprednisolone in a drug.

What condition does NCT01209364 study?

NCT01209364 studies Knee Osteoarthritis.

Is NCT01209364 still recruiting?

NCT01209364 is currently completed. Last updated 24 August 2022.

Last reviewed 2022-08-24 · How we verify

NCT01209364

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Double-Blind, Randomized, Parallel Group, Multicenter Study of Durolane Compared to Methylprednisolone in Subjects With Osteoarthritis of the Knee

Completed Phase 3 Last updated 24 August 2022

What this trial tests

Phase 3 trial testing Durolane is a device, methylprednisolone in a drug in Knee Osteoarthritis in 442 participants. Completed in 1 November 2008.

Timeline

1 March 2007

Primary endpoint
1 January 2008

1 November 2008

Quick facts

Lead sponsor	Galderma R&D
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	442
Start date	1 March 2007
Primary completion	1 January 2008
Estimated completion	1 November 2008
Sites	23 locations across Canada, Sweden, United Kingdom

Drugs / interventions tested

Durolane is a device, methylprednisolone in a drug

Conditions studied

Knee Osteoarthritis — all drugs for Knee Osteoarthritis →

Sponsor

Galderma R&D — full company profile →

Who can join

Adults 35 to 80, any sex, with Knee Osteoarthritis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Pain level and responder rate
Time frame: up to 12 weeks

Sponsor's own description

The primary objective is to determine whether Durolane is non-inferior to methylprednisolone, as assessed by level of pain, when each are given as single intra-articular injections for the relief of pain, in the treatment of symptomatic osteoarthritis of the knee at 12 weeks.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

NASHA hyaluronic acid vs. methylprednisolone for knee osteoarthritis: a prospective, multi-centre, randomized, non-inferiority trial.
Leighton R, Akermark C, Therrien R, Richardson JB, et al · · 2014 · cited 71× · PMID 24185114 · DOI 10.1016/j.joca.2013.10.009

Verify or expand the search:

Other recruiting trials for Knee Osteoarthritis

Currently open trials in the same condition.

NCT06906939 — A Randomized Pilot rTMS Trial for Knee Arthritis Pain and Depression · EARLY_PHASE1 · recruiting
NCT05823727 — Effects of Collagen Peptide Supplementation on Connective Tissue Remodeling, Functional Outcomes, and Wound Healing Afte · NA · recruiting
NCT07370480 — Knee Osteoarthritis and Thermal Spa Treatment · NA · recruiting
NCT07507175 — Gastrocnemius Myofascial Release in Females With Knee Osteoarthritis · NA · recruiting
NCT07386600 — Dexamethasone vs Dexmedetomidine for iPACK + ACB in TKA · NA · recruiting

Other Galderma R&D trials

Trials by the same sponsor.

NCT07047690 — A Study of Nemolizumab for the Treatment of Adults With Systemic Sclerosis · Phase 2 · recruiting
NCT07344584 — A Prospective Pilot Study to Evaluate Safety and Effectiveness of GP0122 and GP0124 for Correction of Lines and Wrinkles · NA · not yet recruiting
NCT07186413 — A Study to Compare the Efficacy, Safety and Pharmacokinetics of Trifarotene 50 mcg/g Cream in Chinese Subjects With Acne · Phase 3 · recruiting
NCT07398989 — A Clinical Study to Assess Efficacy and Tolerability of a Topical Skincare Product on Adults With Mature, Crepey Skin · Phase 4 · completed
NCT06988618 — Real-world Experience on Using Nemolizumab in the Treatment of Moderate-to- Severe Prurigo Nodularis in Adults · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01209364 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Galderma R&D
Last refreshed: 24 August 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01209364.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing