A Study of Chicory for Treatment of Osteoarthritis of the Hip or Knee

This study has been completed.

Sponsor:

Collaborator:

University of Texas, Southwestern Medical Center at Dallas

Information provided by:

Phytomedics Inc.

ClinicalTrials.gov Identifier:

NCT01010919

First received: November 6, 2009

Last updated: November 9, 2009

Last verified: November 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

November 6, 2009

Last Updated Date

November 9, 2009

Start Date ^ICMJE

Not Provided

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Study of Chicory for Treatment of Osteoarthritis of the Hip or Knee

Official Title ^ICMJE

A Phase I Study of Chicory for Treatment of Osteoarthritis of the Hip or Knee

Brief Summary

Extracts of chicory root have anti-inflammatory properties in vitro and in animal models of arthritis. The primary objective of this investigator-initiated, Phase 1, placebo-controlled, double blind, dose-escalating trial is to determine the safety and tolerability of a proprietary bioactive extract of chicory root in patients with osteoarthritis (OA). Secondary objectives are to assess effects on the signs and symptoms of this disorder. Individuals greater than 50 years of age with OA of the hip or knee will be eligible for trial entry.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Not Provided

Condition ^ICMJE

Osteoarthritis

Intervention ^ICMJE

Dietary Supplement: Chicory root extract

Study Arms

Not Provided

Publications *

Olsen NJ, Branch VK, Jonnala G, Seskar M, Cooper M. Phase 1, placebo-controlled, dose escalation trial of chicory root extract in patients with osteoarthritis of the hip or knee. BMC Musculoskelet Disord. 2010 Jul 9;11:156. doi: 10.1186/1471-2474-11-156.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Not Provided

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients must be 50 years of age or older and may be of either gender.
Patients must have have an imaging-confirmed (radiograph or MRI) diagnosis of OA of the hip or knee.
Patients must not have taken a nonsteroidal anti-inflammatory medication for at least 7 days prior to the baseline visit (a single daily aspirin 325 mg or less is allowed throughout the study).
Patients must be able and willing to give informed consent.

Exclusion Criteria:

Any unstable comorbid medical condition that in the opinion of the investigator could interfere with the ability of the patient to complete the study.
Patients who are unable to ambulate and require a wheelchair due to the severity of the arthritis are excluded. Ambulatory aids such as canes and walkers are acceptable.
Patients requiring continuing therapy with nonsteroidal anti-inflammatory drugs are excluded.
Patients requiring any dose of glucocorticoids within the past 30 days are excluded.

Sex/Gender

Sexes Eligible for Study:

All

Ages

50 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Not Provided

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Not Provided

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01010919

Other Study ID Numbers ^ICMJE

PMI-005-01

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Phytomedics Inc.

Collaborators ^ICMJE

University of Texas, Southwestern Medical Center at Dallas

Investigators ^ICMJE

Not Provided

PRS Account

Phytomedics Inc.

Verification Date

November 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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