OsteoarthritisPhase 4NCT01906801
Clinical Efficacy of Glucosamine Plus Diacerein Versus Mono-therapy of Glucosamine
A Phase 4 study testing Glucosamine sulfate and Diacerein in people with Osteoarthritis and Glucosamine, run by Ramathibodi Hospital at 1 site in Thailand.
Trial 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 Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoarthritis, Glucosamine, Diacerein
- What is being tested?
- Glucosamine sulfate and Diacerein
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 148 participants
- Where
- 1 siteThailand
- Study dates
- Jul 2013to Oct 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Department of Orthopaedics, Faculty of Medicine Ramathibodi Hospital, Bangkok, Mahidol University
Bangkok, 10400
About this study
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
- Conditions
- Osteoarthritis, Glucosamine, Diacerein
- Being tested
- Glucosamine sulfate, Diacerein, Placebo (for Diacerein)
- Keywords
- Osteoarthritis, Glucosamine sulfate, Diacerein, Randomized controlled trial
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucosamine sulfateDrug
Also called Viatril-S
DiacereinDrug
Also called Artrodar
Placebo (for Diacerein)Drug
Sugar pill manufactured to mimic Diacerein 50 mg tablet
| Study group | Role | What they receive |
|---|---|---|
| Glucosamine sulfate & Diacerein | Experimental | Glucosamine sulfate (sachet) 1500 mg and Diacerein 50 mg tablet by mouth once daily for 24 weeks Receives: Drug: Glucosamine sulfate; Drug: Diacerein |
| Glucosamine sulfate & Placebo | Active comparator | Glucosamine sulfate 1500 mg and Placebo (for Diacerein) 50 mg by mouth once daily for 24 weeks Receives: Drug: Glucosamine sulfate; Drug: Placebo (for Diacerein) |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain visual analog scores
Measured: 24 weeks
Secondary outcomes (3)
Western Ontario and McMaster Universities Osteoarthritis (WOMAC) scores
Measured: 24 weeks
actual and change of joint space width
Measured: 24 weeks
Rate of gastrointestinal side effects
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ramathibodi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jatupon Kongtharvonskul, Ramathibodi Hospital
- Investigators
- Patarawan Woratanarat, MD, Ph.D, Study director, Department of Orthopaedics, Faculty of Medicine Ramathibodi Hospital, Bangkok, Mahidol University, Thailand.Ammarin Thakkinstian, Ph.D, Study chair, Section for Clinical Epidemiology and Biostatistics, Faculty of Medicine Ramathibodi Hospital, Bangkok, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01906801
- Sponsor's protocol ID
- 04-56-25
- Status last verified
- May 2017
- First submitted
- 20 Jul 2013
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 27729073
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Glucosamine Plus Diacerein Versus Mono-therapy of Glucosamine
- ClinicalTrials.gov ID
- NCT01906801
- Acronym / sponsor ID
- 04-56-25
- Conditions
- Osteoarthritis, Glucosamine, Diacerein
- Keywords
- Osteoarthritis, Glucosamine sulfate, Diacerein, Randomized controlled trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Ramathibodi HospitalUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 24 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glucosamine sulfate & Diacerein | Experimental | Drug: Glucosamine sulfate, Drug: DiacereinGlucosamine sulfate (sachet) 1500 mg and Diacerein 50 mg tablet by mouth once daily for 24 weeks |
| Glucosamine sulfate & Placebo | Active comparator | Drug: Glucosamine sulfate, Drug: Placebo (for Diacerein)Glucosamine sulfate 1500 mg and Placebo (for Diacerein) 50 mg by mouth once daily for 24 weeks |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glucosamine sulfateAlso: Viatril-S | Drug | Glucosamine sulfate & Diacerein, Glucosamine sulfate & Placebo |
| DiacereinAlso: Artrodar | Drug | Glucosamine sulfate & Diacerein |
| Placebo (for Diacerein)Sugar pill manufactured to mimic Diacerein 50 mg tablet | Drug | Glucosamine sulfate & Placebo |
Primary outcome
pain visual analog scores
Time frame: 24 weeks
3 secondary outcomes
Western Ontario and McMaster Universities Osteoarthritis (WOMAC) scores
Time frame: 24 weeks
actual and change of joint space width
Time frame: 24 weeks
Rate of gastrointestinal side effects
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
- Derived from this study: PubMed 27729073Kongtharvonskul 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patarawan Woratanarat, MD, Ph.D study director
Department of Orthopaedics, Faculty of Medicine Ramathibodi Hospital, Bangkok, Mahidol University, Thailand.
Ammarin Thakkinstian, Ph.D study chair
Section for Clinical Epidemiology and Biostatistics, Faculty of Medicine Ramathibodi Hospital, Bangkok, Thailand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Glucosamine sulfate and Diacerein in people with Osteoarthritis and Glucosamine, run by Ramathibodi Hospital at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain visual analog scores (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01906801, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2017.