Different Volumes of Durolane in Knee OA

NCT01265459 | Completed Phase 2 Results

• 1 other identifier: 35GA1001
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Change of Pain Over 26 Weeks (Change From 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 calculated by simply adding the score (from 0 to 4) for each question.

  26 weeks after treatment compared to baseline

Secondary Outcomes (4)

• Number of Participants With Adverse Events as a Measure of Safety and Tolerability From Baseline to 26 Weeks After Treatment.

  From baseline to 26 weeks after treatment

• WOMAC Stiffness Score (Change From Baseline)

  26 weeks after treatment compared to baseline

• WOMAC Physical Function Score (Change From Baseline)

  26 weeks after treatment compared to baseline

• Subject´s Global Assessment of the Status of the Study Knee (Change From Baseline)

  26 weeks after treatment compared to baseline

Study Arms (3)

Durolane 3ml

EXPERIMENTAL

Durolane 3 ml is an Intraarticular hyaluronic acid

Device: Durolane 3 ml, Durolane 4,5 ml, Durolane 6 ml

Durolane 4.5

EXPERIMENTAL

Durolane 4.5 is an Intraarticular hyaluronic acid

Device: Durolane 3 ml, Durolane 4,5 ml, Durolane 6 ml

Durolane 6 ml

EXPERIMENTAL

Durolane 6 ml is an Intraarticular hyaluronic acid

Device: Durolane 3 ml, Durolane 4,5 ml, Durolane 6 ml

Interventions

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

Durolane is an intraarticular hyaluronic acid preparation

Durolane 3ml; Durolane 4.5; Durolane 6 ml

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject (female or male)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (3)

Torsten Adalberth

Malmo, 211 36, Sweden

Location

Christian Akermark

Stockholm, 111 35, Sweden

Location

Johan Isacson

Upplands Vasby, 194 89, Sweden

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Head of Medical Affairs
• Organization: Q-Med AB

reception.SEUPP@galderma.com

+46 (0) 18 4749000

Study Officials

• Per-Erik Melberg, MD

  Kristinelundskliniken, Kristinelundsgatan 13, 411 37 Göteborg

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2010
• First Posted: December 23, 2010
• Study Start: January 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: November 1, 2011
• Last Updated: September 22, 2022
• Results First Posted: January 20, 2014

Record last verified: 2014-03

Locations

SE (3)