OsteoarthritisNCT01356199
Effect of Artronat on the Quality of Life of Patient With Osteoarthritis
A study testing ARTRONAT in people with Osteoarthritis, run by Lescuyer Laboratory at 1 site in France.
Trial summary
The purpose of this study is to determine whether the nutritional supplement ARTRONAT improves the quality of life of patients with osteoarthritis. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- ARTRONAT
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2011to Dec 2013
- Phase
- Interventional
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 40-75 years
- BMI 18.5-30
- osteoarthritis type II or III
Who cannot join
- osteoarthritis type I or IV
- allergy to one of the component of the supplement
- blood pressure > 14/8
- history of knee surgery
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Rééducation et Réadaptation Fonctionnelles de Trestel , Centre Hospitalier Pierre-Le-Damany Lannion
Treviou Treguignec, 22660
About this study
Official title: Effet du complément Alimentaire ARTRONAT(R) Sur la réduction de la Gonalgie Chez Des Sujets Arthrosiques
The purpose of this study is to determine whether the nutritional supplement ARTRONAT improves the quality of life of patients with osteoarthritis.
Read the detailed description
Osteoarthritis is a degenerative disease that greatly impairs the quality of life of patients. A nutritional supplement may help, in association with the normal treatment of osteoarthritis, improving the quality of life of such patients, in reducing pain and/or improving join flexibility.
- Conditions
- Osteoarthritis
- Being tested
- ARTRONAT, PLACEBO
- Keywords
- Gonalgia, Quality of Life, Dietary supplement, Nutrition
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARTRONATDietary supplement
Dietary supplement containing Glucosamine, Chondroïtine and manganese. 6 per day for 8 months.
PLACEBODietary supplement
PLACEBO. 6 per day for 8 months.
| Study group | Role | What they receive |
|---|---|---|
| ARTRONAT | Experimental | Not described Receives: Dietary Supplement: ARTRONAT |
| PLACEBO | 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.
Reduction of gonalgia
measure with the WOMAC.
Measured: T8 months
Secondary outcomes (1)
Evaluation of the satisfactory relief of symptoms of osteoarthritis at each visit after the beginning of supplementation, assessed by the patients.
Subjective global assessment measured on a 10-cm graduated scale (Visual Analogue Scale)
Measured: T2, T4, T6, T8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2011 (estimated)
- Study startOct 2011
- Primary completionJan 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lescuyer Laboratory
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- RDVC Produit de Santé., Association Nationale de Prévention Médicale.
- Responsible party
- Sponsor
- Investigators
- Maurice Cloarec, MD, Study chair, Association Nationale de Prevention MedicaleDominique Baron, MD, Principal investigator, Hospital Center of Lanion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01356199
- Sponsor's protocol ID
- 2011-A00319-32
- Status last verified
- Mar 2014
- First submitted
- 17 May 2011
- Last updated
- 18 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effet du complément Alimentaire ARTRONAT(R) Sur la réduction de la Gonalgie Chez Des Sujets Arthrosiques
- ClinicalTrials.gov ID
- NCT01356199
- Acronym / sponsor ID
- 2011-A00319-32
- Conditions
- Osteoarthritis
- Keywords
- Gonalgia, Quality of Life, Dietary supplement, Nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Lescuyer LaboratoryIndustry (pharma, biotech, devices)
- Collaborators
- RDVC Produit de Santé., Association Nationale de Prévention Médicale.
- Study start
- Oct 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 19 May 2011 (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.
The purpose of this study is to determine whether the nutritional supplement ARTRONAT improves the quality of life of patients with osteoarthritis.
Detailed description
Osteoarthritis is a degenerative disease that greatly impairs the quality of life of patients. A nutritional supplement may help, in association with the normal treatment of osteoarthritis, improving the quality of life of such patients, in reducing pain and/or improving join flexibility.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARTRONAT | Experimental | Dietary Supplement: ARTRONAT |
| PLACEBO | Placebo comparator | Dietary Supplement: PLACEBO |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 40-75 years
- BMI 18.5-30
- osteoarthritis type II or III
Key exclusion criteria (4 listed)
- osteoarthritis type I or IV
- allergy to one of the component of the supplement
- blood pressure > 14/8
- history of knee surgery
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 |
|---|---|---|
| ARTRONATDietary supplement containing Glucosamine, Chondroïtine and manganese. 6 per day for 8 months. | Dietary supplement | ARTRONAT |
| PLACEBOPLACEBO. 6 per day for 8 months. | Dietary supplement | PLACEBO |
Primary outcome
Reduction of gonalgia
Time frame: T8 months
measure with the WOMAC.
1 secondary outcome
Evaluation of the satisfactory relief of symptoms of osteoarthritis at each visit after the beginning of supplementation, assessed by the patients.
Time frame: T2, T4, T6, T8 months
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 18 Mar 2014.
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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.
Maurice Cloarec, MD study chair
Association Nationale de Prevention Medicale
Dominique Baron, MD principal investigator
Hospital Center of Lanion
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ARTRONAT in people with Osteoarthritis, run by Lescuyer Laboratory at 1 site in France.
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 3 inclusion and 4 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 18 Mar 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 France. 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.
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?
Reduction of gonalgia (time frame: T8 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 18 Mar 2014.