Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Trial to Evaluate Efficacy and Safety of Combination of Diacerein and Celecoxib Administered in Patients With Knee OA (DIA IIT_01)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03404479
Recruitment Status : Unknown
Verified February 2018 by Whan-Seok Choi, Seoul St. Mary's Hospital.
Recruitment status was:  Recruiting
First Posted : January 19, 2018
Last Update Posted : February 26, 2018
Sponsor:
Collaborator:
Korea University Guro Hospital
Information provided by (Responsible Party):
Whan-Seok Choi, Seoul St. Mary's Hospital

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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Drug: Diacerein Drug: Celecoxib Phase 4

Detailed Description:

A large epidemiological study in Europe reported that over four-thirds of patients with osteoarthritis received combination therapy with two or more drugs. Approximately 1.5% of patients with osteoarthritis using three or more drugs are using COX-2(Cyclo-oxygenase-2) inhibitors and SYSADOA(Symptomatic slow acting drug), And it has been investigated that much more patients are using the two classes of drugs when the range is extended to other oral NSAIDs other than COX-2 inhibitors. Therefore, considering the characteristics of patients with osteoarthritis, such as basal disease and treatment effects on each type of drug, it is important to find the optimal combination of drugs for each patient characteristics.

There is a previous study using osteoarthritis rat model as a biological basis of diacerein and celecoxib administration. Previous studies have shown that the combined use of Diacerein and Celecoxib improves osteoarthritis.

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Double-blinded, Multi-center, Trial to Evaluate Efficacy and Safety of Combination of Diacerein and Celecoxib Administered Orally in Patients With Knee Osteoarthritis
Actual Study Start Date : January 25, 2018
Estimated Primary Completion Date : January 2, 2019
Estimated Study Completion Date : January 2, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
Drug Information available for: Celecoxib

Arm Intervention/treatment
Experimental: Co-administration group
Co-administration of Diacerein 50mg, Celecoxib 100mg.
Drug: Diacerein
For 12 weeks, administered twice a day by oral.

Drug: Celecoxib
For 12 weeks, administered twice a day by oral.

Active Comparator: Single administration group 1
Single administration of Diacerein 50mg and placebo.
Drug: Diacerein
For 12 weeks, administered twice a day by oral.

Active Comparator: Single administration group 2
Single administration of Celecoxib 100mg and placebo.
Drug: Celecoxib
For 12 weeks, administered twice a day by oral.




Primary Outcome Measures :
  1. pain VAS score [ Time Frame: 12 weeks after randomization ]

    Changes in pain VAS(Visual analogue scale) score before and after 12 weeks of drugs administration.

    (No pain score: 0, Worst pain score: 100)



Secondary Outcome Measures :
  1. pain NRS score [ Time Frame: 12 weeks after randomization ]

    Changes in pain NRS(Numeric rating scale) score before and after 12 weeks of drugs administration.

    (No pain score: 0, Worst pain score: 10)


  2. WOMAC index score [ Time Frame: 12 weeks after randomization ]
    Changes in WOMAC(Western Ontario and mcmaster Universities Osteoarthritis Index) index score before and after 12 weeks of drugs administration (possible score range, Pain: 0-20, Stiffness: 0-8, Physical function: 0-68; Total Score range: 0-96 ('none' to 'extreme'))

  3. GSRS index score [ Time Frame: 12 weeks after randomization ]

    Changes in GSRS(Gastrointestinal symptom rating scale) index score before and after 12 weeks of drugs administration.

    (Score range: 0-45 ('none' to 'extreme'))




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects who voluntarily consented, after listening enough explanation for this study and investigational product.
  2. Adult over 50 years of age.
  3. At least one of the knee pain VAS score is 40mm or more.
  4. 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

  5. Patients who require medication for more than 12 weeks due to osteoarthritis symptoms.
  6. 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.
  7. Those who weigh more than 40kg

Exclusion Criteria:

  1. Secondary knee osteoarthritis
  2. Other inflammatory Knee Osteoarthritis (e.g. gout, rheumatoid arthritis, etc.)
  3. Patients presenting with gastroesophageal reflux disease, peptic ulcer.
  4. Helicobacter infected patients who have not been treated for eradication (recruitment if negative in re-examination after treatment).
  5. Short bowel syndrome that can cause inflammatory bowel disease (ulcerative colitis, Crohn's disease) and drug absorption disorder.
  6. Intestinal obstruction syndrome
  7. Unexplained abdominal pain
  8. ALT(Alanine aminotransferase) level of liver function test exceeded 5 times of reference range
  9. Total bilirubin level exceeded 2 mg / dL
  10. Serum albumin level less than 2 g / dL
  11. Ascites
  12. Hepatic encephalopathy
  13. Hepatitis B, hepatitis C (excluding healthy carriers) or HIV positive
  14. MDRD(Modification of Diet in Renal Disease) Estimated Glomerular filtration rate less than 60 mL / m2
  15. Patients with hyperkalemia (over 5.5 meq / L)
  16. history of asthma, acute rhinitis, nasal polyps, angioedema, urticaria or allergic reactions to aspirin or other non-steroidal anti-inflammatory drugs(including COX-2 inhibitors).
  17. Malignant tumors other than basal cell or squamous cell carcinoma of the skin, CIN(Cervical Intraepitherial Neoplasia) and CIS(Carcinoma in situ) of the cervix, and intraepithelial carcinoma of other areas Within 5 years of consent date.
  18. Medical history of hypersensitivity to the components of the investigational products. (The components of test drug 1 and 2, including the Rhein-based drug)
  19. Patients with an allergic reaction to sulfonamide.
  20. Patients with galactose intolerance, lapp lactase deficiency or glucose-galactose malabsorption.
  21. Subjects who have not reached the prescribed period after receiving contraindicated medication or treatment before participation in this clinical trial.
  22. Patients receiving contraindicated medication.
  23. Alcohol and other drug abuse cases based on 6 months before screening.
  24. Pregnant women or nursing mothers who are not willing to stop breastfeeding.
  25. Female who do not fall into one or more of the following categories(In other words, only the following female can participate:)

    • (1) Menopause (non-therapy-induced amenorrhea of more than 12 months) Female
    • (2) Female infertility due to surgery (no ovaries and / or uterus)
    • (3) If you have sexual intercourse with only one male partner who has been confirmed to have no semen after fertilization.
    • (4) Female subjects who agreed to abstinence during the clinical trial period.
    • If the subject is assured of an abstinence throughout the trial period.(e.g. clergy)
    • However, intermittent abstinence (eg, contraception using ovulation period, symptothermal) or coitus interrupts is not a case of consent for abstinence.
    • (5) For women of childbearing age, the following methods or methods of contraception use the effective method of contraception to be used during the period of this clinical trial:
    • Oral contraceptive
    • The contraceptive patch
    • Intra uterine device (IUD)
    • contraceptive implant
    • contraceptive injection
    • intrauterine hormonal apparatus
    • Tubal ligation and infertility surgery
  26. If 30 days have not elapsed after the date of signing of the previous clinical trial or currently participating in other clinical trials.
  27. Patients who are scheduled for surgery during the clinical trial period or who have difficulties in completing the protocol during this clinical trial due to other reasons.
  28. In addition to the above, other diseases that the investigator judges to be inappropriate.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03404479


Contacts
Layout table for location contacts
Contact: Yu-na Jo 82-70-4335-5448 ynjo@symyoo.com
Contact: Sung Woon Yang 82-31-354-0604 yangsw7@naver.com

Locations
Layout table for location information
Korea, Republic of
Seoul ST. Mary's Hospital Recruiting
Seoul, Korea, Republic of, 06591
Contact: Whan-Seok Choi, M.D., Ph.D.    82-2-2258-6285    fmchs@catholic.ac.kr   
Principal Investigator: Whan-Seok Choi, M.D., Ph.D         
Sub-Investigator: Chul-Min Kim, M.D., Ph.D         
Sub-Investigator: Ji Hyeon Ju, M.D., Ph.D         
Korea University Guro Hospital Recruiting
Seoul, Korea, Republic of, 08308
Contact: Seon-Mee Kim, MD, PhD    82-2-2626-3276    ksmpdh@korea.ac.kr   
Principal Investigator: Seon-Mee Kim, M.D., Ph.D.         
Sponsors and Collaborators
Whan-Seok Choi
Korea University Guro Hospital
Investigators
Layout table for investigator information
Principal Investigator: Whan-Seok Choi, MD, PhD Seoul St. Mary's Hospital
Principal Investigator: Seon-Mee Kim, MD, PhD Korea University Guro Hospital
Publications:
Layout table for additonal information
Responsible Party: Whan-Seok Choi, Professor, Seoul St. Mary's Hospital
ClinicalTrials.gov Identifier: NCT03404479    
Other Study ID Numbers: DIA IIT_01
First Posted: January 19, 2018    Key Record Dates
Last Update Posted: February 26, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Whan-Seok Choi, Seoul St. Mary's Hospital:
Knee Osteoarthritis
Diacerein
Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Celecoxib
Diacetylrhein
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action