Who is sponsoring NCT01265459?

NCT01265459 is sponsored by Galderma R&D.

What drugs are being tested in NCT01265459?

Interventions in NCT01265459: Durolane 3 ml, Durolane 4,5 ml, Durolane 6 ml.

What condition does NCT01265459 study?

NCT01265459 studies Knee Osteoarthritis.

Is NCT01265459 still recruiting?

NCT01265459 is currently completed. Last updated 24 August 2022.

Are results published for NCT01265459?

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

NCT01265459

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

Double-Blind, Randomized Study of Three Different Volumes of Durolane in Subjects With Osteoarthritis of the Knee

Completed Phase 2 Results posted Last updated 24 August 2022

What this trial tests

Phase 2 trial testing Durolane 3 ml, Durolane 4,5 ml, Durolane 6 ml in Knee Osteoarthritis in 68 participants. Completed in 1 November 2011.

Timeline

1 January 2011

Primary endpoint
1 September 2011

1 November 2011

Quick facts

Lead sponsor	Galderma R&D
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	68
Start date	1 January 2011
Primary completion	1 September 2011
Estimated completion	1 November 2011
Sites	3 locations across Sweden

Drugs / interventions tested

Durolane 3 ml, Durolane 4,5 ml, Durolane 6 ml

Conditions studied

Knee Osteoarthritis — all drugs for Knee Osteoarthritis →

Sponsor

Galderma R&D — full company profile →

Who can join

Adults 40 to 85, 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.

Change of Pain Over 26 Weeks (Change From Baseline)
Time frame: 26 weeks after treatment compared to baseline
The study aims to compare the change of pain for different volumes of study product over 26 weeks using WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) pain score that consists of 5 questions. It is a 5-graded Likert scale: None, Mild, Moderate, Severe or Extreme relating to how much pain the subject has experienced during the last 48 hours. The score of each dimension is c

Sponsor's own description

The purpose of the study is to assess the safety and efficacy profiles of new single-injection volumes of Durolane in patients with knee OA.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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 NCT01265459 (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/NCT01265459.

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