Clinical Efficacy of Glucosamine Plus Diacerein Versus Mono-therapy of Glucosamine

May 25, 2017 updated by: Jatupon Kongtharvonskul, Ramathibodi Hospital
The purpose of this study is to compare pain scores, WOMAC total and subscores, actual and change of joint space width and the rate of gastrointestinal side effects at 4, 8, 12, and 24 weeks between dual-therapy of diacerein and glucosamine versus a mono-therapy of glucosamine in OA patients

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

148

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10400
        • Department of Orthopaedics, Faculty of Medicine Ramathibodi Hospital, Bangkok, Mahidol University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Adult patients age 50 years or older who have been diagnosed as primary or secondary osteoarthritis of the knee base on clinical criteria of American College of Rheumatology

Inclusion Criteria:

  • Clinical diagnosis of primary osteoarthritis
  • Mild deformity Clinical (having no varus or valgus deformity, no crepitus) ? Physical examination grade 0 assessed by stress test Radiographic assessment (Kellgrane-lawrance type II-III), a minimum baseline medial tibiofemoral JSW of _2 mm.
  • Willing to participate and provide written informed consent

Exclusion Criteria:

  • Non-secondary osteoarthritis Rheumatoid arthritis, inflammatory arthritis (e.g. SLE, Gout), post traumatic osteoarthritis, those who received intra-articular treatment of the signal joint with any product (corticosteroids in the previous 2 months, or glycosaminoglycans/hyaluronic acid in the previous 6 months) or had undergone joint lavage andarthroscopic procedures in the previous 6 months.
  • No contraindication of using diacerein and glucosamine
  • Non-current or ex-users of oral SYSADOA (e.g., glucosamine sulphate, chondroitin sulphate, diacerein, piascledine), anti-depressants, tranquillisers, antacids or antibiotics known hypersensitivity to diacerein, to similar compounds, to the excipients or to paracetamol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Glucosamine sulfate & Diacerein
Glucosamine sulfate (sachet) 1500 mg and Diacerein 50 mg tablet by mouth once daily for 24 weeks
Drug: Diacerein
Other Names:
  • Artrodar
Drug: Glucosamine sulfate
Other Names:
  • Viatril-S
ACTIVE_COMPARATOR: Glucosamine sulfate & Placebo
Glucosamine sulfate 1500 mg and Placebo (for Diacerein) 50 mg by mouth once daily for 24 weeks
Drug: Glucosamine sulfate
Other Names:
  • Viatril-S
Drug: Placebo (for Diacerein)
Sugar pill manufactured to mimic Diacerein 50 mg tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
pain visual analog scores
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Western Ontario and McMaster Universities Osteoarthritis (WOMAC) scores
Time Frame: 24 weeks
24 weeks
actual and change of joint space width
Time Frame: 24 weeks
24 weeks
Rate of gastrointestinal side effects
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ramathibodi Hospital

Investigators

  • Study Director: Patarawan Woratanarat, MD, Ph.D, Department of Orthopaedics, Faculty of Medicine Ramathibodi Hospital, Bangkok, Mahidol University, Thailand.
  • Study Chair: Ammarin Thakkinstian, Ph.D, Section for Clinical Epidemiology and Biostatistics, Faculty of Medicine Ramathibodi Hospital, Bangkok, Thailand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (ACTUAL)

October 1, 2014

Study Completion (ACTUAL)

October 1, 2014

Study Registration Dates

First Submitted

July 20, 2013

First Submitted That Met QC Criteria

July 23, 2013

First Posted (ESTIMATE)

July 24, 2013

Study Record Updates

Last Update Posted (ACTUAL)

May 30, 2017

Last Update Submitted That Met QC Criteria

May 25, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04-56-25

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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