Chondroitin Sulphate Treatment Efficacy in Rhizarthrosis. | NCT01233739

Studies
Chondroitin Sulphate Treatment Efficacy in Rhizarthrosis.

NCT01233739

Sponsor

Juan A. Arnaiz

Status

Unknown status

Last Update Posted

Feb 22, 2013Estimated

Enrollment

108Estimated

Phase

Phase 4

Conditions

Rhizarthrosis

Interventions

Chondroitin sulfate
Placebo

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2011

Primary Completion Date

Apr 2013Estimated

Completion Date

Apr 2013Estimated

First Submitted Date

Nov 2, 2010

First Submission Date that Met QC Criteria

Nov 2, 2010

First Posted Date

Nov 3, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 21, 2013

Last Update Posted Date

Feb 22, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

108Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator		Drug: Placebo
Chondroitin sulfate	Experimental	Administration of 2 capsules of 400 mg of chondroitin sulfate orally.	Drug: Chondroitin sulfate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Chondroitin sulfate	Drug	Administration of 2 capsules of 400 mg of chondroitin sulfate orally.	Chondroitin sulfate

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluation with visual analogue pain scale as mean at the last weak		36 weeks

Secondary Outcomes

Measure	Description	Time Frame
Sollerman test	Evaluation of hand function with Sollerman test	36 weeks
Hand pressure force		36 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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
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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Judit Pich, Pharmacist	Contact	+34 93 227 54 00	2336	jpich@clinic.ub.es

Overall Officials

Name	Affiliation	Role
Joaquím Forés, MD	Hospital Clínic i Provincial de Barcelona	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Clínic i Provincial de Barcelona	Recruiting	Barcelona	Catalonia	08038	Spain

ID	Term
D002807	Chondroitin
D006025	Glycosaminoglycans
D011134	Polysaccharides
D002241	Carbohydrates