Phase 2
Completed N=68
Different Volumes of Durolane in Knee OA
Source: ClinicalTrials.gov NCT01265459 ↗Enrolled (actual)
68
Serious AEs
4.4%
Results posted
Jan 2014
Primary outcomePrimary: Change of Pain Over 26 Weeks (Change From Baseline) — -4.13; -4.00; -4.90 units on a scale
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change of Pain Over 26 Weeks (Change From Baseline) |
-4.13; -4.00; -4.90 | — |
| SECONDARY Number of Participants With Adverse Events as a Measure of Safety and Tolerability From Baseline to 26 Weeks After Treatment. |
8; 12; 14 | — |
| SECONDARY WOMAC Stiffness Score (Change From Baseline) |
-1.30; -1.39; -1.15 | — |
| SECONDARY WOMAC Physical Function Score (Change From Baseline) |
-11.14; -13.13; -12.32 | — |
| SECONDARY Subject´s Global Assessment of the Status of the Study Knee (Change From Baseline) |
1.43; 1.39; 1.70 | — |
Eligibility Criteria
Inclusion Criteria
- Subject (female or male)
- 40-85 years of age
- Unilateral knee pain fulfilling American College of Rheumatology (ACR) criteria for diagnosis of osteoarthritis(OA)
- Radiographic evidence of OA in the study knee
- WOMAC pain score of 7-17 in the study knee
- WOMAC pain score of 2-3 in the study knee (WOMAC Likert 3.1 A1)
- Subject normally active
- Subject has attempted but not responded adequately to previous non-pharmacological therapy(ies)and to simple analgetics
- Subject cooperative and able to communicate effectively with the investigators
- Body mass index ≤ 35 kg/m2;
- Signed informed consent obtained
Exclusion Criteria
- Knee effusion
- Contralateral knee OA
- Clinically significant joint pain from joints other than the knee
- Previous intra-articular steroid injection into the study knee within the last 6 months
- Previous intra-articular Hyaluronic Acid (HA) injection into the study knee within the last 9 months
- Previous allergic type reaction to a HA product
- Treatment with analgesics other than paracetamol (acetaminophen) (including topical agents for the knee) within 5 half lives of the drug prior to the baseline visit
- Use of analgesics 48 hours preceding the baseline visit
- Use of systemic glucocorticosteroids (excluding inhaled steroids) within the last 3 months
- Treatment with glucosamine/chondroitin sulfate initiated within the past 3 months
- Change in physical therapy for the knee within the last three months
- Arthroscopy or other surgical procedure in the study knee within the past 12 months
- Serious injuries to the study knee in the past
- Any planned arthroscopy or other surgical procedure during the study period
- Previous history or presence of active septic arthritis
- Active skin disease or infection in the area of the injection site
- Systemic active inflammatory condition or infection
- Bleeding diathesis or use of anticoagulants
- History of drug or alcohol abuse within 6 months
- Any medical condition that in the opinion of the investigator makes the subject unsuitable for inclusion
- Pregnant or breastfeeding woman or woman of childbearing potential not practicing adequate contraception
- Involvement in other clinical trials
Data sourced from ClinicalTrials.gov (NCT01265459). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.