NCT01906801

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
148

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2013

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

July 1, 2013

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

July 20, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 24, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

May 30, 2017

Status Verified

May 1, 2017

Enrollment Period

1.3 years

First QC Date

July 20, 2013

Last Update Submit

May 25, 2017

Conditions

OsteoarthritisGlucosamineDiacerein

Keywords

OsteoarthritisGlucosamine sulfateDiacereinRandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • pain visual analog scores

    24 weeks

Secondary Outcomes (3)

  • Western Ontario and McMaster Universities Osteoarthritis (WOMAC) scores

    24 weeks

  • actual and change of joint space width

    24 weeks

  • Rate of gastrointestinal side effects

    24 weeks

Study Arms (2)

Glucosamine sulfate & Diacerein

EXPERIMENTAL

Glucosamine sulfate (sachet) 1500 mg and Diacerein 50 mg tablet by mouth once daily for 24 weeks

Drug: Glucosamine sulfateDrug: Diacerein

Glucosamine sulfate & Placebo

ACTIVE COMPARATOR

Glucosamine sulfate 1500 mg and Placebo (for Diacerein) 50 mg by mouth once daily for 24 weeks

Drug: Glucosamine sulfateDrug: Placebo (for Diacerein)

Interventions

Glucosamine sulfateDRUG
Also known as: Viatril-S
Glucosamine sulfate & DiacereinGlucosamine sulfate & Placebo
DiacereinDRUG
Also known as: Artrodar
Glucosamine sulfate & Diacerein
Placebo (for Diacerein)DRUG

Sugar pill manufactured to mimic Diacerein 50 mg tablet

Glucosamine sulfate & Placebo

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Orthopaedics, Faculty of Medicine Ramathibodi Hospital, Bangkok, Mahidol University

Bangkok, 10400, Thailand

Location

Related Publications (1)

  • Kongtharvonskul J, Woratanarat P, McEvoy M, Attia J, Wongsak S, Kawinwonggowit V, Thakkinstian A. Efficacy of glucosamine plus diacerein versus monotherapy of glucosamine: a double-blind, parallel randomized clinical trial. Arthritis Res Ther. 2016 Oct 12;18(1):233. doi: 10.1186/s13075-016-1124-9.

    PMID: 27729073DERIVED

MeSH Terms

Conditions

Osteoarthritis

Interventions

Glucosaminediacerein

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

HexosaminesAmino SugarsCarbohydrates

Study Officials

  • Patarawan Woratanarat, MD, Ph.D

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

    STUDY DIRECTOR

  • Ammarin Thakkinstian, Ph.D

    Section for Clinical Epidemiology and Biostatistics, Faculty of Medicine Ramathibodi Hospital, Bangkok, Thailand

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Section for Clinical Epidemiology and Biostatistics, Faculty of Medicine Ramathibodi Hospital, Bangkok, Thailand

Study Record Dates

First Submitted

July 20, 2013

First Posted

July 24, 2013

Study Start

July 1, 2013

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

May 30, 2017

Record last verified: 2017-05

Locations

TH(1)