Knee OsteoarthritisPhase 4NCT02104596
Intraarticular Xylitol Injections for Knee Osteoarthritis
A Phase 4 study testing Xylitol in people with Knee Osteoarthritis, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
Hypothesis: Intraarticular injections of isotonic Xylitol solution will improve pain in patients with knee osteoarthritis (OA). Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Xylitol
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteIsrael
- Study dates
- May 2014to Apr 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 45
- Tibiofemoral osteoarthritis
- OA stage 2-3 on xray
- Pain VAS > 40mm
- No NSAIDs for 3 weeks
- No analgetics for 38 hours
Who cannot join
- Pain VAS > 80mm
- Pain VAS in contralateral knee > 40mm
- Inflammatory arthritis
- Severe effusion
- Posttraumatic osteoarthritis
- Unstable knee
- Isolated patellofemoral disease
- Paracetamol hypersensitivity
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hadassah Medical Organization, Jerusalem, Israel
Jerusalem
Hadas Lemberg, 00 972 2 6776095, lhadas@hadassah.org.il
About this study
Hypothesis: Intraarticular injections of isotonic Xylitol solution will improve pain in patients with knee osteoarthritis (OA).
- Conditions
- Knee Osteoarthritis
- Being tested
- Xylitol
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XylitolDevice
| Study group | Role | What they receive |
|---|---|---|
| Xylitol injection | Experimental | Intraarticular injection of Xylitol Receives: Device: Xylitol |
| Control | Placebo comparator | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain - visual analogue scale
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2014 (estimated)
- Study startMay 2014
- Primary completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, KANDEL, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02104596
- Sponsor's protocol ID
- Xylitol- HMO-CTIL
- Status last verified
- Apr 2014
- First submitted
- 2 Apr 2014
- Last updated
- 17 Apr 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraarticular Xylitol Injections for Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT02104596
- Acronym / sponsor ID
- Xylitol- HMO-CTIL
- Conditions
- Knee Osteoarthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Apr 2016 (estimated)
- First posted
- 4 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hypothesis: Intraarticular injections of isotonic Xylitol solution will improve pain in patients with knee osteoarthritis (OA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xylitol injection | Experimental | Device: XylitolIntraarticular injection of Xylitol |
| Control | Placebo comparator | – |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age over 45
- Tibiofemoral osteoarthritis
- OA stage 2-3 on xray
- Pain VAS > 40mm
- No NSAIDs for 3 weeks
Key exclusion criteria (8 listed)
- Pain VAS > 80mm
- Pain VAS in contralateral knee > 40mm
- Inflammatory arthritis
- Severe effusion
- Posttraumatic osteoarthritis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xylitol | Device | Xylitol injection |
Primary outcome
Pain - visual analogue scale
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2014.
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The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Xylitol in people with Knee Osteoarthritis, run by Hadassah Medical Organization at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leonid Kandel, MD (+97225844500, kandel@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain - visual analogue scale (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2014.