Assessment of the Effects of Chondroitin Sulphate in Pati... | NCT01226615

Studies
Assessment of the Effects of Chondroitin Sulphate in Patients With Knee Osteoarthritis With Functional Magnetic Resonance Imaging (fMRI)

NCT01226615

Sponsor

Bioiberica

Status

Unknown status

Last Update Posted

Oct 2, 2012Estimated

Enrollment

64Actual

Phase

Phase 4

Conditions

Knee Osteoarthritis

Interventions

Chondroitin sulphate (Condrosan®)
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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2010

Primary Completion Date

Oct 2011Actual

Completion Date

Dec 2012Estimated

First Submitted Date

Oct 8, 2010

First Submission Date that Met QC Criteria

Oct 21, 2010

First Posted Date

Oct 22, 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

Oct 1, 2012

Last Update Posted Date

Oct 2, 2012Estimated

Description Module

Brief Summary

The main purposes of this study are:

to determine the effects of chondroitin sulphate on brain response to pain assessed through fMRI in patients with knee osteoarthritis.
to investigate the relationship between treatment response detected by fMRI and the results of the different parameters of clinical assessment.

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

64Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Chondroitin sulphate	Drug: Chondroitin sulphate (Condrosan®)
2	Placebo Comparator	Placebo	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Chondroitin sulphate (Condrosan®)	Drug	800mg (two capsules of 400mg each) taken once a day for four months	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Brain response to pain caused on arthritic knee selected by fMRI	Functional magnetic resonance imaging (fMRI) is particularly suited to investigating the effects of pharmacological agents on pain processing within the human central nervous system. The measures are based on the haemodynamic resonse to a neuronal event and constitute indirect measures of excitatory and inhibitory neuronal activity. The neuronal activation is associated with an increase of the oxygen extraction fraction from the capillaries and with an increase in regional cerebral blood flow. The measure which derived from blood oxygenation is called the BOLD effect.	4 months

Secondary Outcomes

Measure	Description	Time Frame
Assessment of the reduction of pain by Huskisson VAS		4 months
Determination of pain and functional capacity using the Lequesne Algofunctional Index		4 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Primary knee OA according to ACR criteria
OA of radiological stages 2 to 3 according to Kellgren-Lawrence
Estable knee pain during the last months before to start the clinical trial
Patients with pain as the VAS≥50mm at baseline

Exclusion Criteria:

Patients with skin conditions that could interfere in the clinical trial evaluation
Pregnant or breastfeeding woman
Patients with a history of alcoholism or other drug abuse
Patients with an uncontrolled active psychiatric disorder
Patients with other inflammatory or systemic conditions affecting other joints
Patients who suffer more intense pain in the joint in another location
Patients unable to differentiate between symptoms caused by the knee in front of the joint study opposite
OA of radiological stages 1 or 4 according to Kellgren-Lawrence
Other bone and articular diseases such as chondrocalcinosis, Paget's disease, rheumatoid arthritis, aseptic osteonecrosis, gout, septic arthritis, ochronosis, acromegaly, hemochromatosis, Wilson's disease, osteochondromatosis
Patients with contraindications to perform an MRI such as: certain tattoos, pacemakers, intracranial clips incompatible with MRI, in the heart valves, hearing aids and other types of implants are incompatible with MRI
Known allergy to chondroitin sulphate
Washout period for OA treatments before beginning the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Jordi Monfort, MD	Hospital del Mar	Principal Investigator
Jesús Pujol, MD	Hospital del Mar	Principal Investigator

Type	Date	Date Unknown
Release	Mar 10, 2015
Reset	Mar 18, 2015
Release	Jan 23, 2018
Reset	Oct 29, 2018

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Mar 10, 2015			Mar 18, 2015
Jan 23, 2018

ID	Term
D010003	Osteoarthritis
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

ID	Term
D006025	Glycosaminoglycans
D011134	Polysaccharides
D002241	Carbohydrates