RhizarthrosisPhase 4NCT01233739
Chondroitin Sulphate Treatment Efficacy in Rhizarthrosis.
A Phase 4 study testing Chondroitin sulfate in people with Rhizarthrosis, run by Juan A. Arnaiz at 1 site in Spain.
Trial summary
Patients who present rhizarthrosis diagnostic will be randomized to be treated with chondroitin sulfate or placebo during 24 weeks to study the effect of the treatment with objective and subjective indicators of pain and sensibility. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Rhizarthrosis
- What is being tested?
- Chondroitin sulfate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2011to Apr 2013
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- both sex patients
- age between 45 to 75 years
- with mechanical pain at the trapezium-thumb metacarpal joint of more than 3 months duration
- grade II or III Eaton \& Glickel rhizarthrosis radiological diagnose
- pain at inclusion of >= 40 mm at a visual analogue scale
- without rehabilitation treatment or infiltration in the last 6 months
- who accept to participate and sign informed consent
Who cannot join
- patients with rhizarthrosis resulted from rheumatic disease
- patients with joint surgery or traumatic background
- illiterate patients or unable to understand informed consent
- patients with previous neuropsychopathology enough severe to unable participation at the study
- patients with peripheral sensory impairment due to diabetes, peripheral neuropathy or central neurological sequelae of disease in the affected limb that can alter sensory perception
- patients with coagulopathy
Show all 10Show fewer
- inflammation for other process at the joint at study
- in treatment with non-steroidal anti-inflammatory drug in the last 7 days and/or corticosteroid in the last 30 days
- allergy or hypersensibility at chondroitin sulfate or its excipients
- pregnant or breastfeeding woman
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clínic i Provincial de Barcelona
Barcelona, Catalonia, 08038
Joaquim Forés, MD
About this study
Official title: Chondroitin Sulphate Treatment Efficacy in Rhizarthrosis. Measurement With Sensory and Quantitive Functional Tests and Concordance Analysis With Subjective Scales of Pain.
Patients who present rhizarthrosis diagnostic will be randomized to be treated with chondroitin sulfate or placebo during 24 weeks to study the effect of the treatment with objective and subjective indicators of pain and sensibility.
- Conditions
- Rhizarthrosis
- Being tested
- Chondroitin sulfate, Placebo
- Keywords
- rhizarthrosis, Chondroitin sulfate, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chondroitin sulfateDrug
Administration of 2 capsules of 400 mg of chondroitin sulfate orally.
PlaceboDrug
Administration of 2 capsules of placebo orally.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Chondroitin sulfate | Experimental | Administration of 2 capsules of 400 mg of chondroitin sulfate orally. Receives: Drug: Chondroitin sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation with visual analogue pain scale as mean at the last weak
Measured: 36 weeks
Secondary outcomes (11)
Sollerman test
Evaluation of hand function with Sollerman test
Measured: 36 weeks
Hand pressure force
Measured: 36 weeks
Thumb-index finger pincer force
Measured: 36 weeks
Dash test
Osteoarthritis functional test
Measured: 36 weeks
SF-12 test
Quality of life test
Measured: 36 weeks
Mechanical sensitivity measured with electronic Von Frey filament
Measured: 36 weeks
vibratory and thermic sensibility threshold assisted by computer
Measured: 36 weeks
Use of paracetamol or other analgesic drugs
recorded in a patient diary
Measured: 36 weeks
Evolution of trapezium-thumb metacarpal joint by ultrasound scan
Measured: 36 weeks
Hematologic evaluation
Measured: 24 weeks
Biochemical evaluation
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2010 (estimated)
- Study startMar 2011
- Primary completionApr 2013 (estimated)
- Study completionApr 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RhizarthrosisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Juan A. Arnaiz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Juan A. Arnaiz, Hospital Clinic of Barcelona
- Investigators
- Joaquím Forés, MD, Principal investigator, Hospital Clínic i Provincial de Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01233739
- Sponsor's protocol ID
- RIZACONDRO
- Status last verified
- Feb 2013
- First submitted
- 2 Nov 2010
- Last updated
- 22 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chondroitin Sulphate Treatment Efficacy in Rhizarthrosis. Measurement With Sensory and Quantitive Functional Tests and Concordance Analysis With Subjective Scales of Pain.
- ClinicalTrials.gov ID
- NCT01233739
- Acronym / sponsor ID
- RIZACONDRO
- Conditions
- Rhizarthrosis
- Keywords
- rhizarthrosis, Chondroitin sulfate, Placebo
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Juan A. ArnaizUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Apr 2013 (estimated)
- Study completion
- Apr 2013 (estimated)
- First posted
- 3 Nov 2010 (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.
Patients who present rhizarthrosis diagnostic will be randomized to be treated with chondroitin sulfate or placebo during 24 weeks to study the effect of the treatment with objective and subjective indicators of pain and sensibility.
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 |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Chondroitin sulfate | Experimental | Drug: Chondroitin sulfateAdministration of 2 capsules of 400 mg of chondroitin sulfate orally. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- both sex patients
- age between 45 to 75 years
- with mechanical pain at the trapezium-thumb metacarpal joint of more than 3 months duration
- grade II or III Eaton \& Glickel rhizarthrosis radiological diagnose
- pain at inclusion of >= 40 mm at a visual analogue scale
Key exclusion criteria (10 listed)
- patients with rhizarthrosis resulted from rheumatic disease
- patients with joint surgery or traumatic background
- illiterate patients or unable to understand informed consent
- patients with previous neuropsychopathology enough severe to unable participation at the study
- patients with peripheral sensory impairment due to diabetes, peripheral neuropathy or central neurological sequelae of disease in the affected limb that can alter sensory perception
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 |
|---|---|---|
| Chondroitin sulfateAdministration of 2 capsules of 400 mg of chondroitin sulfate orally. | Drug | Chondroitin sulfate |
| PlaceboAdministration of 2 capsules of placebo orally. | Drug | Placebo |
Primary outcome
Evaluation with visual analogue pain scale as mean at the last weak
Time frame: 36 weeks
11 secondary outcomes
Sollerman test
Time frame: 36 weeks
Hand pressure force
Time frame: 36 weeks
Thumb-index finger pincer force
Time frame: 36 weeks
Dash test
Time frame: 36 weeks
SF-12 test
Time frame: 36 weeks
Mechanical sensitivity measured with electronic Von Frey filament
Time frame: 36 weeks
vibratory and thermic sensibility threshold assisted by computer
Time frame: 36 weeks
Use of paracetamol or other analgesic drugs
Time frame: 36 weeks
Evolution of trapezium-thumb metacarpal joint by ultrasound scan
Time frame: 36 weeks
Hematologic evaluation
Time frame: 24 weeks
Biochemical evaluation
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2013.
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Rhizarthrosis
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.
Joaquím Forés, MD principal investigator
Hospital Clínic i Provincial de Barcelona
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 Chondroitin sulfate in people with Rhizarthrosis, run by Juan A. Arnaiz at 1 site in Spain.
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 10 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 22 Feb 2013. 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 Spain. 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 Judit Pich, Pharmacist (+34 93 227 54 00 ext. 2336, jpich@clinic.ub.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation with visual analogue pain scale as mean at the last weak (time frame: 36 weeks). 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 22 Feb 2013.