Last reviewed · How we verify
NCT01806207
A Double-blind, Randomized, Multi-centre Study of the Efficacy and Safety of a Single Intra-articular Injection With Durolane Compared to Saline in Patients With Unilateral Knee Osteoarthritis
Phase 4 trial testing Durolane injection in Unilateral Knee Osteoarthritis in 218 participants. Completed.
1 April 2004
Quick facts
| Lead sponsor | Galderma R&D |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 218 |
| Start date | 1 February 2003 |
| Primary completion | 1 April 2004 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- Durolane injection
- Saline injection
Conditions studied
- Unilateral Knee Osteoarthritis — all drugs for Unilateral Knee Osteoarthritis →
Sponsor
Galderma R&D — full company profile →
Who can join
50 and older, any sex, with Unilateral 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.
-
Proportion of responders at 6 weeks.
Time frame: At 6 weeks after treatment
Proportion of responders was based on the improvement in WOMAC (Western Ontario and McMasters Universities Osteoarthritis Index) pain score.
Sponsor's own description
This was a study that compared Durolane injections to saline injections in the treatment of unilateral osteoarthritis of the knee. The patients were randomly assigned one of the two treatments unaware of which treatment they received. The study was conducted at 13 centers in Germany, the United Kingdom and Sweden. Patients were followed for six weeks after study treatment.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
A randomized saline-controlled trial of NASHA hyaluronic acid for knee osteoarthritis.
Arden NK, Åkermark C, Andersson M, Todman MG, et al · · 2014 · cited 41× · PMID 24168077 · DOI 10.1185/03007995.2013.855631
Verify or expand the search:
- PubMed search for NCT01806207
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01806207 (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/NCT01806207.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing