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NCT02104596 Clinical Trial

Intraarticular Xylitol Injections for Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:
Intraarticular Xylitol Injections for Knee Osteoarthritis

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT02104596
Other study ID # Xylitol- HMO-CTIL
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received April 2, 2014
Last updated April 16, 2014
Start date May 2014

Study information
Verified date April 2014
Source Hadassah Medical Organization
Contact Leonid Kandel, MD
Phone +97225844500
Email kandel@hadassah.org.il
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Interventional

Clinical Trial Summary

Hypothesis: Intraarticular injections of isotonic Xylitol solution will improve pain in patients with knee osteoarthritis (OA).

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 96
Est. completion date
Est. primary completion date April 2016
Accepts healthy volunteers No
Gender Both
Age group 45 Years and older
Eligibility Inclusion Criteria:

- Age over 45

- Tibiofemoral osteoarthritis

- OA stage 2-3 on xray

- Pain VAS > 40mm

- No NSAIDs for 3 weeks

- No analgetics for 38 hours

Exclusion Criteria:

- Pain VAS > 80mm

- Pain VAS in contralateral knee > 40mm

- Inflammatory arthritis

- Severe effusion

- Posttraumatic osteoarthritis

- Unstable knee

- Isolated patellofemoral disease

- Paracetamol hypersensitivity

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Xylitol

Locations
Country Name City State
Israel Hadassah Medical Organization, Jerusalem, Israel Jerusalem

Sponsors (1)
Lead Sponsor Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pain - visual analogue scale 3 months No
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