Intraarticular Xylitol Injections for Knee Osteoarthritis | NCT02104596

Studies
Intraarticular Xylitol Injections for Knee Osteoarthritis

NCT02104596

Sponsor

Hadassah Medical Organization

Status

Unknown status

Last Update Posted

Apr 17, 2014Estimated

Enrollment

96Estimated

Phase

Phase 4

Conditions

Knee Osteoarthritis

Interventions

Xylitol

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2014

Primary Completion Date

Apr 2016Estimated

Completion Date

Not provided

First Submitted Date

Apr 2, 2014

First Submission Date that Met QC Criteria

Apr 3, 2014

First Posted Date

Apr 4, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 16, 2014

Last Update Posted Date

Apr 17, 2014Estimated

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

96Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Xylitol injection	Experimental	Intraarticular injection of Xylitol	Device: Xylitol
Control	Placebo Comparator

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Xylitol	Device		Xylitol injection

Measure	Description	Time Frame
Pain - visual analogue scale		3 months

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Leonid Kandel, MD	Contact	+97225844500		kandel@hadassah.org.il

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hadassah Medical Organization, Jerusalem, Israel		Jerusalem			Israel

Condition Browse Module

MeSH Terms

ID	Term
D020370	Osteoarthritis, Knee

Ancestor Terms

ID	Term
D010003	Osteoarthritis
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided