Trial to Evaluate Efficacy and Safety of Combination of Diacerein and Celecoxib Administered in Patients With Knee OA

NCT03404479 | Unknown Phase 4

• 1 other identifier: DIA IIT_01
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to evaluate the pain relief effect of Co-administration of Diacerein with Celecoxib in patients with knee osteoarthritis compared with single administration of each drug.

Conditions

Knee Osteoarthritis

Keywords

Knee Osteoarthritis; Diacerein

Outcome Measures

Primary Outcomes (1)

• pain VAS score

  Changes in pain VAS(Visual analogue scale) score before and after 12 weeks of drugs administration. (No pain score: 0, Worst pain score: 100)

  12 weeks after randomization

Secondary Outcomes (3)

• pain NRS score

  12 weeks after randomization

• WOMAC index score

  12 weeks after randomization

• GSRS index score

  12 weeks after randomization

Study Arms (3)

Co-administration group

EXPERIMENTAL

Co-administration of Diacerein 50mg, Celecoxib 100mg.

Drug: Diacerein; Drug: Celecoxib

Single administration group 1

ACTIVE COMPARATOR

Single administration of Diacerein 50mg and placebo.

Drug: Diacerein

Single administration group 2

ACTIVE COMPARATOR

Single administration of Celecoxib 100mg and placebo.

Drug: Celecoxib

Interventions

Diacerein DRUG

For 12 weeks, administered twice a day by oral.

Co-administration group; Single administration group 1

Celecoxib DRUG

For 12 weeks, administered twice a day by oral.

Co-administration group; Single administration group 2

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who voluntarily consented, after listening enough explanation for this study and investigational product.
• Adult over 50 years of age.
• At least one of the knee pain VAS score is 40mm or more.
• Meets the ACR(American College of Rheumatology) criteria for diagnosis. (1) Confirmation of osteophytes on radiographic inspection. (2) One or more of the following three items.
• ① Age\> 50 years
• ② Morning stiffness \<30 minutes
• ③ Crepitus
• Patients who require medication for more than 12 weeks due to osteoarthritis symptoms.
• Those who are able to follow the requirements of this clinical trial, such as being able to trace during the clinical trial period and to read and write the VAS questionnaire.
• Those who weigh more than 40kg

You may not qualify if:

• Secondary knee osteoarthritis
• Other inflammatory Knee Osteoarthritis (e.g. gout, rheumatoid arthritis, etc.)
• Patients presenting with gastroesophageal reflux disease, peptic ulcer.
• Helicobacter infected patients who have not been treated for eradication (recruitment if negative in re-examination after treatment).
• Short bowel syndrome that can cause inflammatory bowel disease (ulcerative colitis, Crohn's disease) and drug absorption disorder.
• Intestinal obstruction syndrome
• Unexplained abdominal pain
• ALT(Alanine aminotransferase) level of liver function test exceeded 5 times of reference range
• Total bilirubin level exceeded 2 mg / dL
• Serum albumin level less than 2 g / dL
• Ascites
• Hepatic encephalopathy
• Hepatitis B, hepatitis C (excluding healthy carriers) or HIV positive
• MDRD(Modification of Diet in Renal Disease) Estimated Glomerular filtration rate less than 60 mL / m2
• Patients with hyperkalemia (over 5.5 meq / L)

Sponsors & Collaborators

• Whan-Seok Choi: lead
• Korea University Guro Hospital: collaborator

Study Sites (2)

Seoul ST. Mary's Hospital

Seoul, 06591, South Korea

RECRUITING

Korea University Guro Hospital

Seoul, 08308, South Korea

RECRUITING

Related Publications (4)

• Li Z, Meng D, Li G, Xu J, Tian K, Li Y. Celecoxib Combined with Diacerein Effectively Alleviates Osteoarthritis in Rats via Regulating JNK and p38MAPK Signaling Pathways. Inflammation. 2015 Aug;38(4):1563-72. doi: 10.1007/s10753-015-0131-3.

  PMID: 25687638 BACKGROUND

• Martel-Pelletier J, Pelletier JP. Effects of diacerein at the molecular level in the osteoarthritis disease process. Ther Adv Musculoskelet Dis. 2010 Apr;2(2):95-104. doi: 10.1177/1759720X09359104.

  PMID: 22870441 BACKGROUND

• Panova E, Jones G. Benefit-risk assessment of diacerein in the treatment of osteoarthritis. Drug Saf. 2015 Mar;38(3):245-52. doi: 10.1007/s40264-015-0266-z.

  PMID: 25652235 BACKGROUND

• Nicolas P, Tod M, Padoin C, Petitjean O. Clinical pharmacokinetics of diacerein. Clin Pharmacokinet. 1998 Nov;35(5):347-59. doi: 10.2165/00003088-199835050-00002.

  PMID: 9839088 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

diacerein; Celecoxib

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Whan-Seok Choi, MD, PhD

  Seoul St. Mary's Hospital

  PRINCIPAL INVESTIGATOR

• Seon-Mee Kim, MD, PhD

  Korea University Guro Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu-na Jo

CONTACT

82-70-4335-5448; ynjo@symyoo.com

Sung Woon Yang

CONTACT

82-31-354-0604; yangsw7@naver.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 12, 2018
• First Posted: January 19, 2018
• Study Start: January 25, 2018
• Primary Completion: January 2, 2019
• Study Completion: January 2, 2019
• Last Updated: February 26, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)