OsteoarthritisPhase 2/3EFONCT00977444
Evaluation of a New Formulation Useful for the Osteoarthrosis Treatment
A Phase 2/3 study testing kondrium, kondrium f and methyl prednisolone (corticosteroid) in people with Osteoarthritis, run by Nucitec at 1 site in Mexico.
Trial summary
Abstract Kondrium, is a pharmaceutical composition for the treatment of osteoarthritis (OA). This study was designed to evaluate the efficacy and safety of kondrium in the treatment of OA of knee. A 3 month, randomized, double-blind, active-controlled, parallel-group study will be carried out. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- kondrium, kondrium f and methyl prednisolone (corticosteroid)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteMexico
- Study dates
- Nov 2007to Oct 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age > 40 years
- symptomatic evidence of OA in the knee for at least 1 year
- radiographic evidence of Kellgren and Lawrence grade II to IV OA of the knee
- no intra-articular injection of corticosteroids within the last 3 months
Who cannot join
- any history of adverse reaction to the study drugs
- current pregnancy status
- uncontrolled hypertension
- active infection
- undergone surgery/arthroscopy within three months
- diagnosis of radiographic OA of Kellgren and Lawrence grade I
Trial locations and contacts
1 site in 1 country.
About this study
Abstract
Kondrium, is a pharmaceutical composition for the treatment of osteoarthritis (OA). This study was designed to evaluate the efficacy and safety of kondrium in the treatment of OA of knee.
A 3 month, randomized, double-blind, active-controlled, parallel-group study will be carried out. 117 patients with OA of the knee will be randomized to receive 1 intra-articular monthly injection of 5 mL of one of the following: 75 mg/mL of Kondrium, 82.5 mg/mL of Kondriumf or 8 mg/mL of methylprednisolone once a month during 3 months. The primary efficacy variable will be the change from baseline to final assessment in the Western Ontario and McMaster University OA index (WOMAC subscale score for pain), and Lequesne´s functional index.
Read the detailed description
The WOMAC osteoarthritis index is a validated, multidimensional, disease specific, health status measure. It probes clinically important patient relevant symptoms in the areas of pain, stiffness and physical function in patients with hip and/or knee osteoarthritis. It consists of 24 questions in three separated subscales (5 questions on pain subscale, 17 questions on physical function subscales and 2 questions on stiffness subscale), each scored in analog scale from 0 to 10 points (0 representing no pain, 10 representing extreme pain). Each subscale score was weighed 10 points, thus 30 was the maximum punctuation for WOMAC total score.
The Lequesne index is a 10-question interview-style survey given to patients with osteoarthritis of the knee. It has 5 questions pertaining to pain or discomfort, 1 question dealing with maximum distance walked, and 4 questions about daily activities. The total questionnaire is scored on a 0 to 24 scale, with lower scores meaning less functional impairment.
- Conditions
- Osteoarthritis
- Being tested
- kondrium, kondrium f, methyl prednisolone (corticosteroid)
- Keywords
- knee, osteoarthritis
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kondriumDrug
intraarticular injections once month
kondrium fDrug
intraarticular injections once month
methyl prednisolone (corticosteroid)Drug
Also called corticosteroid
intraarticular injections once month
| Study group | Role | What they receive |
|---|---|---|
| kondrium | Experimental | intraarticular injections once month Receives: Drug: kondrium |
| kondrium f | Experimental | Not described Receives: Drug: kondrium f |
| corticosteroid | Active comparator | intraarticular injections once month Receives: Drug: methyl prednisolone (corticosteroid) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy variable is the change from baseline to final assessment in the Western Ontario and McMastern University OA index (WOMAC), and Lequesne´s functional index.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2009 (estimated)
- Study startNov 2007
- Primary completionFeb 2009 (estimated)
- Study completionOct 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nucitec
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Council of Science and Technology, Mexico
- Investigators
- Ricardo Amador, PhD, Principal investigator, Hospital San Jose
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00977444
- Sponsor's protocol ID
- PEE-002-2007
- Acronym
- EFO
- Status last verified
- Jan 2010
- First submitted
- 11 Sep 2009
- Last updated
- 20 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Caamano MDC, Garcia-Padilla S, Duarte-Vazquez MA, Gonzalez-Romero KE, Rosado JL. A Double-Blind, Active-Controlled Clinical Trial of Sodium Bicarbonate and Calcium Gluconate in the Treatment of Bilateral Osteoarthritis of the Knee. Clin Med Insights Arthritis Musculoskelet Disord. 2017 Feb 16;10:1179544116688899. doi: 10.1177/1179544116688899. eCollection 2017.
PubMed 28469486Garcia-Padilla S, Duarte-Vazquez MA, Gonzalez-Romero KE, Caamano Mdel C, Rosado JL. Effectiveness of intra-articular injections of sodium bicarbonate and calcium gluconate in the treatment of osteoarthritis of the knee: a randomized double-blind clinical trial. BMC Musculoskelet Disord. 2015 May 13;16:114. doi: 10.1186/s12891-015-0568-4.
PubMed 25963758
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a New Formulation Useful for the Osteoarthrosis Treatment
- ClinicalTrials.gov ID
- NCT00977444
- Acronym / sponsor ID
- EFO / PEE-002-2007
- Conditions
- Osteoarthritis
- Keywords
- knee, osteoarthritis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 114 participants (actual)
- Lead sponsor
- NucitecIndustry (pharma, biotech, devices)
- Collaborators
- National Council of Science and Technology, Mexico
- Study start
- Nov 2007
- Primary completion
- Feb 2009 (estimated)
- Study completion
- Oct 2009 (estimated)
- First posted
- 15 Sep 2009 (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.
Abstract
Kondrium, is a pharmaceutical composition for the treatment of osteoarthritis (OA). This study was designed to evaluate the efficacy and safety of kondrium in the treatment of OA of knee.
A 3 month, randomized, double-blind, active-controlled, parallel-group study will be carried out. 117 patients with OA of the knee will be randomized to receive 1 intra-articular monthly injection of 5 mL of one of the following: 75 mg/mL of Kondrium, 82.5 mg/mL of Kondriumf or 8 mg/mL of methylprednisolone once a month during 3 months. The primary efficacy variable will be the change from baseline to final assessment in the Western Ontario and McMaster University OA index (WOMAC subscale score for pain), and Lequesne´s functional index.
Detailed description
The WOMAC osteoarthritis index is a validated, multidimensional, disease specific, health status measure. It probes clinically important patient relevant symptoms in the areas of pain, stiffness and physical function in patients with hip and/or knee osteoarthritis. It consists of 24 questions in three separated subscales (5 questions on pain subscale, 17 questions on physical function subscales and 2 questions on stiffness subscale), each scored in analog scale from 0 to 10 points (0 representing no pain, 10 representing extreme pain). Each subscale score was weighed 10 points, thus 30 was the maximum punctuation for WOMAC total score.
The Lequesne index is a 10-question interview-style survey given to patients with osteoarthritis of the knee. It has 5 questions pertaining to pain or discomfort, 1 question dealing with maximum distance walked, and 4 questions about daily activities. The total questionnaire is scored on a 0 to 24 scale, with lower scores meaning less functional impairment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| kondrium | Experimental | Drug: kondriumintraarticular injections once month |
| kondrium f | Experimental | Drug: kondrium f |
| corticosteroid | Active comparator | Drug: methyl prednisolone (corticosteroid)intraarticular injections once month |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age > 40 years
- symptomatic evidence of OA in the knee for at least 1 year
- radiographic evidence of Kellgren and Lawrence grade II to IV OA of the knee
- no intra-articular injection of corticosteroids within the last 3 months
Key exclusion criteria (6 listed)
- any history of adverse reaction to the study drugs
- current pregnancy status
- uncontrolled hypertension
- active infection
- undergone surgery/arthroscopy within three months
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 |
|---|---|---|
| kondriumintraarticular injections once month | Drug | kondrium |
| kondrium fintraarticular injections once month | Drug | kondrium f |
| methyl prednisolone (corticosteroid)Also: corticosteroidintraarticular injections once month | Drug | corticosteroid |
Primary outcome
The primary efficacy variable is the change from baseline to final assessment in the Western Ontario and McMastern University OA index (WOMAC), and Lequesne´s functional index.
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2010.
- Derived from this study: PubMed 28469486Caamano MDC, Garcia-Padilla S, Duarte-Vazquez MA, Gonzalez-Romero KE, Rosado JL. A Double-Blind, Active-Controlled Clinical Trial of Sodium Bicarbonate and Calcium Gluconate in the Treatment of Bilateral Osteoarthritis of the Knee. Clin Med Insights Arthritis Musculoskelet Disord. 2017 Feb 16;10:1179544116688899. doi: 10.1177/1179544116688899. eCollection 2017.
- Derived from this study: PubMed 25963758Garcia-Padilla S, Duarte-Vazquez MA, Gonzalez-Romero KE, Caamano Mdel C, Rosado JL. Effectiveness of intra-articular injections of sodium bicarbonate and calcium gluconate in the treatment of osteoarthritis of the knee: a randomized double-blind clinical trial. BMC Musculoskelet Disord. 2015 May 13;16:114. doi: 10.1186/s12891-015-0568-4.
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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.
Ricardo Amador, PhD principal investigator
Hospital San Jose
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 kondrium, kondrium f and methyl prednisolone (corticosteroid) in people with Osteoarthritis, run by Nucitec at 1 site in Mexico.
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 4 inclusion and 6 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 20 Jan 2010. 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 Mexico. 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. 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?
Results are not available in the source record.
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 primary efficacy variable is the change from baseline to final assessment in the Western Ontario and McMastern University OA index (WOMAC), and Lequesne´s functional index. (time frame: 4 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 NCT00977444, which also lists 2 linked publications.
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 20 Jan 2010.