Knee Osteoarthritis (OA)Phase 2/3NMRNCT00536302
A Placebo-Controlled Study of Collagen Hydrolysate in Subjects With Knee Osteoarthritis (OA)
A Phase 2/3 study testing Collagen Hydrolysate in people with Knee Osteoarthritis (OA), run by GELITA at 1 site in United States.
Trial summary
This study is designed to evaluate, by MRI, knee cartilage and structure in all subjects. Half the subjects in this study will take collagen hydrolysate each day for 48 weeks and the other half of the subjects will take a placebo dose, that looks like and tastes like the collagen hydrolysate, each day for 48 weeks. Read more about this study
- Who is it for?
- Ages 49 to 90 years
- Conditions the study is for
- Knee Osteoarthritis (OA)
- What is being tested?
- Collagen Hydrolysate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Jan 2009
- Phase
- Phase 2/3
- 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 49 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age > 49 years
- chronic knee discomfort based on the affirmative response to the question "During the past 6 months, have you had any pain in the knee more than half the days of the month ?"
- WOMAC pain subscale score ≥ 1
- tibiofemoral or patellofemoral osteoarthritis on anteroposterior weight-bearing semi-flexed or lateral knee radiographs with at least one osteophyte and no significant joint-space-narrowing
- clinical examination confirming knee pain or discomfort referable to the knee joint
- prepared to refrain from use of glucosamine, chondroitin, sAME and doxycycline
- stable medication and/or supplement use
Who cannot join
- use of glucosamine, chondroitin, diacerein or doxycycline within 14 weeks prior to randomization
- serious medical conditions or impairments that, in the view of the investigator, would obstruct their participation in the trial
- individuals who are expected not to comply with the study protocol
- plan to permanently relocate from the region during the trial period
- planned knee arthroplasty in the study knee
- active pathology of confounding origin which may cause pain, extending to the knee
- pregnancy
- any contra-indication to having an MRI scan
Trial locations and contacts
1 site in 1 country.
United States1 site
Tufts Medical Center; Center for Arthritis and Rheumatic Diseases
Boston, Massachusetts, 02111
About this study
Official title: A Single Center, Prospective, Randomized, Placebo-Controlled, Double-Blind Pilot Clinical Trial to Evaluate the Sensitivity of Magnetic Resonance Imaging to Detect Change in Cartilage Structure and Composition in 30 Participants Diagnosed With Osteoarthritis of the Knee and Treated With Collagen Hydrolysate
This study is designed to evaluate, by MRI, knee cartilage and structure in all subjects. Half the subjects in this study will take collagen hydrolysate each day for 48 weeks and the other half of the subjects will take a placebo dose, that looks like and tastes like the collagen hydrolysate, each day for 48 weeks. MRIs will be taken at Study Weeks -1, 24, and 48.
Read the detailed description
This is a single-site, double-blind, pilot study to evaluate the sensitivity of MRI to detect cartilage structure and composition in subjects taking daily oral collagen hydrolysate (a nutritional supplement) or placebo for 48 weeks. 30 subjects will be randomized to collagen hydrolysate or placebo (1:1 ratio). The goal is to evaluate, by MRI, knee cartilage and structure in all subjects. The primary functional outcome measure will be the WOMAC questionnaire and the primary pathological outcome measure will be knee cartilage structure and composition as measurements done by MRI imaging. Subjects will have contrast dGEMRIC MRIs done at Study Weeks -1, 24 and 48.
- Conditions
- Knee Osteoarthritis (OA)
- Being tested
- Collagen Hydrolysate, Placebo
- Keywords
- OA, Knee arthritis, Osteoarthritis, Nutritional supplement, CAM, MRI
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collagen HydrolysateDietary supplement
Collagen Hydrolysate solution 10 grams per day by mouth for 48 weeks
PlaceboDietary supplement
Matching placebo solution per day by mouth for 48 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Collagen Hydrolysate Receives: Dietary Supplement: Collagen Hydrolysate |
| 2 | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the effect of collagen hydrolysate on knee cartilage as measured by MRI.
Measured: 48 Weeks
Secondary outcomes (3)
To measure knee cartilage volume over 48 weeks at three time points.
Measured: 48 Weeks
To measure and evaluate WOMAC pain subscale scores over 48 weeks.
Measured: 48 Weeks
To evaluate change in physical function tests over 48 weeks.
Measured: 48 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2007 (estimated)
- Study startMar 2007
- Primary completionNov 2008
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee Osteoarthritis (OA)Studies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- GELITA
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Timothy E McAlindon, MD, MPH, Principal investigator, Tufts Medical Center; Center for Arthritis and Rheumatic Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00536302
- Sponsor's protocol ID
- Gelita TM 1
- Acronym
- NMR
- Status last verified
- Feb 2009
- First submitted
- 26 Sep 2007
- Last updated
- 6 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
McAlindon T, Bartnik E, S Ried J, Teichert L, Herrmann M, Flechsenhar K. Determination of serum biomarkers in osteoarthritis patients: a previous interventional imaging study revisited. J Biomed Res. 2016 Oct 17;31(1):25-30. doi: 10.7555/JBR.31.20150167.
PubMed 28808182
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Prospective, Randomized, Placebo-Controlled, Double-Blind Pilot Clinical Trial to Evaluate the Sensitivity of Magnetic Resonance Imaging to Detect Change in Cartilage Structure and Composition in 30 Participants Diagnosed With Osteoarthritis of the Knee and Treated With Collagen Hydrolysate
- ClinicalTrials.gov ID
- NCT00536302
- Acronym / sponsor ID
- NMR / Gelita TM 1
- Conditions
- Knee Osteoarthritis (OA)
- Keywords
- OA, Knee arthritis, Osteoarthritis, Nutritional supplement, CAM, MRI
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- GELITAIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Nov 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 27 Sep 2007 (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.
This study is designed to evaluate, by MRI, knee cartilage and structure in all subjects. Half the subjects in this study will take collagen hydrolysate each day for 48 weeks and the other half of the subjects will take a placebo dose, that looks like and tastes like the collagen hydrolysate, each day for 48 weeks. MRIs will be taken at Study Weeks -1, 24, and 48.
Detailed description
This is a single-site, double-blind, pilot study to evaluate the sensitivity of MRI to detect cartilage structure and composition in subjects taking daily oral collagen hydrolysate (a nutritional supplement) or placebo for 48 weeks. 30 subjects will be randomized to collagen hydrolysate or placebo (1:1 ratio). The goal is to evaluate, by MRI, knee cartilage and structure in all subjects. The primary functional outcome measure will be the WOMAC questionnaire and the primary pathological outcome measure will be knee cartilage structure and composition as measurements done by MRI imaging. Subjects will have contrast dGEMRIC MRIs done at Study Weeks -1, 24 and 48.
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 |
|---|---|---|
| 1 | Experimental | Dietary Supplement: Collagen HydrolysateCollagen Hydrolysate |
| 2 | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 49 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- age > 49 years
- chronic knee discomfort based on the affirmative response to the question "During the past 6 months, have you had any pain in the knee more than half the days of the month ?"
- WOMAC pain subscale score ≥ 1
- tibiofemoral or patellofemoral osteoarthritis on anteroposterior weight-bearing semi-flexed or lateral knee radiographs with at least one osteophyte and no significant joint-space-narrowing
- clinical examination confirming knee pain or discomfort referable to the knee joint
Key exclusion criteria (8 listed)
- use of glucosamine, chondroitin, diacerein or doxycycline within 14 weeks prior to randomization
- serious medical conditions or impairments that, in the view of the investigator, would obstruct their participation in the trial
- individuals who are expected not to comply with the study protocol
- plan to permanently relocate from the region during the trial period
- planned knee arthroplasty in the study knee
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 |
|---|---|---|
| Collagen HydrolysateCollagen Hydrolysate solution 10 grams per day by mouth for 48 weeks | Dietary supplement | 1 |
| PlaceboMatching placebo solution per day by mouth for 48 weeks. | Dietary supplement | 2 |
Primary outcome
To measure the effect of collagen hydrolysate on knee cartilage as measured by MRI.
Time frame: 48 Weeks
3 secondary outcomes
To measure knee cartilage volume over 48 weeks at three time points.
Time frame: 48 Weeks
To measure and evaluate WOMAC pain subscale scores over 48 weeks.
Time frame: 48 Weeks
To evaluate change in physical function tests over 48 weeks.
Time frame: 48 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2009.
- Derived from this study: PubMed 28808182McAlindon T, Bartnik E, S Ried J, Teichert L, Herrmann M, Flechsenhar K. Determination of serum biomarkers in osteoarthritis patients: a previous interventional imaging study revisited. J Biomed Res. 2016 Oct 17;31(1):25-30. doi: 10.7555/JBR.31.20150167.
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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.
Timothy E McAlindon, MD, MPH principal investigator
Tufts Medical Center; Center for Arthritis and Rheumatic Diseases
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Collagen Hydrolysate in people with Knee Osteoarthritis (OA), run by GELITA at 1 site in United States.
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 7 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: finished, as of the sponsor's last update on 6 Feb 2009. 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 United States. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To measure the effect of collagen hydrolysate on knee cartilage as measured by MRI. (time frame: 48 Weeks). 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 NCT00536302, 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 6 Feb 2009.