Chondroitin Sulphate Treatment Efficacy in Rhizarthrosis.

NCT ID: NCT01233739

Last Updated: 2013-02-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2013-04-30

Brief Summary

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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

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Conditions

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Rhizarthrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administration of 2 capsules of placebo orally.

Chondroitin sulfate

Administration of 2 capsules of 400 mg of chondroitin sulfate orally.

Group Type EXPERIMENTAL

Chondroitin sulfate

Intervention Type DRUG

Administration of 2 capsules of 400 mg of chondroitin sulfate orally.

Interventions

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Chondroitin sulfate

Administration of 2 capsules of 400 mg of chondroitin sulfate orally.

Intervention Type DRUG

Placebo

Administration of 2 capsules of placebo orally.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Juan A. Arnaiz

OTHER

Sponsor Role lead

Responsible Party

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Juan A. Arnaiz

MD, PhD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Joaquím Forés, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clínic i Provincial de Barcelona

Locations

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Hospital Clínic i Provincial de Barcelona

Barcelona, Catalonia, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Judit Pich, Pharmacist

Role: CONTACT

+34 93 227 54 00 ext. 2336

Other Identifiers

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RIZACONDRO

Identifier Type: -

Identifier Source: org_study_id

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