Knee OsteoarthritisNCT02237989

Effects Of Native Collagen Type 2 Treatment

A study testing paracetamol and paracetamol+native collagen type 2 in people with Knee Osteoarthritis, run by Eskisehir Osmangazi University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The aim of this study was to evaluate symptomatic efficacy of native collagen type 2 on joint pain and function and its effects on urinary biological markers related to cartilage degeneration in patients with knee osteoarthritis. Read more about this study

Who is it for?: Ages 45 to 70 years
Conditions the study is for: Knee Osteoarthritis
What is being tested?: paracetamol and paracetamol+native collagen type 2
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 39 participants
Where: No sites listed yet
Study dates: Jan 2013to Dec 2013
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Inclusion Criteria:Patients aged 45-70 years with the diagnosis of primary knee OA according to the American College of Rheumatology (ACR) criteria, Kellgren Lawrence radiological stage II or III and knee pain -

Exclusion Criteria:Patients with intraarticular injections or physical therapy within the last year, a previous lower extremity surgery, oral treatment with glucosamine chondroitin or other natural health products within the last month, serious concomitant systemic diseases, peripheral or central neurological disorder, hypersensitivity to paracetamol or se¬vere cardiac, renal, hepatic, hematologic disease

About this study

Official title: Effects Of Native Collagen Type 2 Treatment In Knee Osteoarthritis : A Randomized Controlled Trial

Read the detailed description

39 patients diagnosed with knee osteoarthritis were separated into two groups. The 1st group includes 19 patients given 1500mg/day paracetamol, the 2nd group consists of 20 patients given 1500mg/day paracetamol and 10mg/day native collagen type 2 for three months.Pretreatment and posttreatment Visual Analog Scale, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), 20-m walking time and Short Form-36 (SF-36), Coll2-1, Coll2-1NO2 and Fibulin-3 levels in urine were compared.

Conditions: Knee Osteoarthritis
Being tested: paracetamol, paracetamol+native collagen type 2
Keywords: knee osteoarthritis, native collagen type 2, paracetamol
Medical subject headings: Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

paracetamolDrug
1500 mg
paracetamol+native collagen type 2Drug
paracetamol (1500 mg) + native collagen type 2 (10mg)

Study groups in NCT02237989
Study group	Role	What they receive
paracetamol	Active comparator	The 1st group includes 19 patients given 1500mg/day paracetamol for three months Receives: Drug: paracetamol
native collagen type 2 + paracetamol	Experimental	The 2nd group consists of 20 patients given 1500mg/day paracetamol and 10mg/day native collagen type 2 for three months Receives: Drug: paracetamol+native collagen type 2

What is being measured

The primary outcome is the main question the study is designed to answer.

the Change From Baseline in Pain During Walking Visual Analog Scale (VAS Walking)
Post treatment comparison of VAS walking between the groups minimum score is 0, maximum score is 10. The clinic of the patient worses when the score increases.
Measured: 3 months

Secondary outcomes (4)

the Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score
Post treatment comparison of WOMAC between the groups minimum score is 0, maximum score is 100. The clinic of the patient worses when the score increases.
Measured: 3 months
the Change From Baseline in 20 Meters Walking Time
Post treatment comparison of 20 meters walking time between the groups When the time increases, clinical of the patient worses
Measured: 3 months
the Change From Baseline in Short Form 36 / Bodily Pain Subgroup
Post treatment comparison of short form 36-bodily pain between groups minimum score 0 maximum score 100 When the score increases, clinic of patient gets better
Measured: 3 months
the Change From Baseline in Coll2-1 Levels
Post treatment comparison of Coll2-1 levels between groups
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2013Dec 2013

First posted12 Sep 2014 (estimated)
Study startJan 2013
Primary completionDec 2013
Study completionDec 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 39 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02237989
Sponsor's protocol ID: FY2001
Status last verified: Sep 2020
First submitted: 10 Sep 2014
Last updated: 18 Sep 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Bakilan F, Armagan O, Ozgen M, Tascioglu F, Bolluk O, Alatas O. Effects of Native Type II Collagen Treatment on Knee Osteoarthritis: A Randomized Controlled Trial. Eurasian J Med. 2016 Jun;48(2):95-101. doi: 10.5152/eurasianjmed.2015.15030.
PubMed 27551171

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis

All Knee Osteoarthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects Of Native Collagen Type 2 Treatment In Knee Osteoarthritis : A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT02237989
Acronym / sponsor ID: FY2001
Conditions: Knee Osteoarthritis
Keywords: knee osteoarthritis, native collagen type 2, paracetamol
Study type: Interventional
Recruitment status: Completed
Enrolment: 39 participants (actual)
Lead sponsor: Eskisehir Osmangazi UniversityUniversity, hospital or other
Study start: Jan 2013
Primary completion: Dec 2013 (actual)
Study completion: Dec 2013 (actual)
First posted: 12 Sep 2014 (estimated)
Results: Posted 18 Sep 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
paracetamol	Active comparator	Drug: paracetamolThe 1st group includes 19 patients given 1500mg/day paracetamol for three months
native collagen type 2 + paracetamol	Experimental	Drug: paracetamol+native collagen type 2The 2nd group consists of 20 patients given 1500mg/day paracetamol and 10mg/day native collagen type 2 for three months

Who may qualify

Ages: 45 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

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
paracetamol1500 mg	Drug	paracetamol
paracetamol+native collagen type 2paracetamol (1500 mg) + native collagen type 2 (10mg)	Drug	native collagen type 2 + paracetamol

Primary outcome

the Change From Baseline in Pain During Walking Visual Analog Scale (VAS Walking)
Time frame: 3 months
Post treatment comparison of VAS walking between the groups minimum score is 0, maximum score is 10. The clinic of the patient worses when the score increases.

4 secondary outcomes

the Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score
Time frame: 3 months
the Change From Baseline in 20 Meters Walking Time
Time frame: 3 months
the Change From Baseline in Short Form 36 / Bodily Pain Subgroup
Time frame: 3 months
the Change From Baseline in Coll2-1 Levels
Time frame: 3 months

Results and safety

Results posted to the registry on 18 Sep 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Paracetamol	19	19
Native Collagen Type 2 + Paracetamol	20	20

Primary outcome: the Change From Baseline in Pain During Walking Visual Analog Scale (VAS Walking)

Time frame: 3 months. Median (Inter-Quartile Range). Unit: score on a scale

Measure	Paracetamol n = 19	Native Collagen Type 2 + Paracetamol n = 20
Value	3 (0 to 9)	3 (0 to 9)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 3 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment Group	0 of 20 (0%)	0 of 20 (0%)	0 of 20
Control Group	0 of 19 (0%)	0 of 19 (0%)	0 of 19

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27551171Bakilan F, Armagan O, Ozgen M, Tascioglu F, Bolluk O, Alatas O. Effects of Native Type II Collagen Treatment on Knee Osteoarthritis: A Randomized Controlled Trial. Eurasian J Med. 2016 Jun;48(2):95-101. doi: 10.5152/eurasianjmed.2015.15030.

Related trials for Knee Osteoarthritis

Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis

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.

Fulya Bakilan, Specialist study director

Yerkoy State Hospital

Questions about this trial

What is this clinical trial studying?

A study testing paracetamol and paracetamol+native collagen type 2 in people with Knee Osteoarthritis, run by Eskisehir Osmangazi University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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: finished, as of the sponsor's last update on 18 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the Change From Baseline in Pain During Walking Visual Analog Scale (VAS Walking) (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02237989, which also lists 1 linked publication.

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 18 Sep 2020; AzTrials last refreshed its copy on 6 Nov 2026.