NCT01753830 is a NA clinical trial of Durolane in Knee Osteoarthritis, sponsored by Galderma R&D.

Who is sponsoring NCT01753830?

NCT01753830 is sponsored by Galderma R&D.

What drugs are being tested in NCT01753830?

Interventions in NCT01753830: Durolane, PBS.

What condition does NCT01753830 study?

NCT01753830 studies Knee Osteoarthritis.

Is NCT01753830 still recruiting?

NCT01753830 is currently terminated. Last updated 24 August 2022.

Are results published for NCT01753830?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2022-08-24 · How we verify

NCT01753830

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

A Multi Center, Randomized, Double Blind, Saline Controlled Study of a Single Injection of Durolane® Versus a Single Injection of Phosphate Buffered Saline (PBS) to Treat Pain Associated With Osteoarthritis of the Knee

Terminated NA Results posted Last updated 24 August 2022

What this trial tests

NA trial testing Durolane in Knee Osteoarthritis in 75 participants. Terminated before completion.

Timeline

1 December 2012

Primary endpoint
1 February 2014

1 February 2014

Quick facts

Lead sponsor	Galderma R&D
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	75
Start date	1 December 2012
Primary completion	1 February 2014
Estimated completion	1 February 2014
Sites	25 locations across United States

Drugs / interventions tested

Durolane — full drug profile →
PBS — full drug profile →

Conditions studied

Knee Osteoarthritis — all drugs for Knee Osteoarthritis →

Sponsor

Galderma R&D — full company profile →

Who can join

Adults 40 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.

Average Change in WOMAC VAS Pain Score From Week 6 to Week 30
Time frame: Up to 30 weeks
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain score (0-100 mm Visual Analogue Scale (VAS)). Lower score mean less pain.

Sponsor's own description

The purpose of the study is to determine whether a single intra-articular injection of Durolane 4.5 mL is superior to a single injection of PBS 4.5 mL for the relief of joint pain in patients with osteoarthritis of the knee.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of Durolane

Trials testing the same drug.

NCT03762408 — Efficacy and Safety of a Intra-articular Injection, ENKO1, in Patients With Symptomatic Knee Osteoarthritis. · NA · completed
NCT04000204 — The Comparison of Two Crosslinked Hyaluronate for the Treatment of Osteoarthritis Pain · NA · completed
NCT02610504 — Prospective Single Center Open Label Study of Shoulder OA Pain · NA · completed

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 NCT01753830 (US National Library of Medicine, public domain)
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/NCT01753830.

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