NCT01233739

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
108

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2011

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 3, 2010

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

February 22, 2013

Status Verified

February 1, 2013

Enrollment Period

2.1 years

First QC Date

November 2, 2010

Last Update Submit

February 21, 2013

Conditions

Rhizarthrosis

Keywords

rhizarthrosisChondroitin sulfatePlacebo

Outcome Measures

Primary Outcomes (1)

  • Evaluation with visual analogue pain scale as mean at the last weak

    36 weeks

Secondary Outcomes (11)

  • Sollerman test

    36 weeks

  • Hand pressure force

    36 weeks

  • Thumb-index finger pincer force

    36 weeks

  • Dash test

    36 weeks

  • SF-12 test

    36 weeks

  • +6 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Chondroitin sulfate

EXPERIMENTAL

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

Drug: Chondroitin sulfate

Interventions

Chondroitin sulfateDRUG

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

Chondroitin sulfate
PlaceboDRUG

Administration of 2 capsules of placebo orally.

Placebo

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • without rehabilitation treatment or infiltration in the last 6 months
  • who accept to participate and sign informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clínic i Provincial de Barcelona

Barcelona, Catalonia, 08038, Spain

RECRUITING

MeSH Terms

Interventions

Chondroitin Sulfates

Intervention Hierarchy (Ancestors)

ChondroitinGlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Joaquím Forés, MD

    Hospital Clínic i Provincial de Barcelona

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Judit Pich, Pharmacist

CONTACT

+34 93 227 54 00jpich@clinic.ub.es

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

November 2, 2010

First Posted

November 3, 2010

Study Start

March 1, 2011

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

February 22, 2013

Record last verified: 2013-02

Locations

ES(1)