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

Effect Observation Study of COX-2 Inhibitor to Treat Primary Hypertrophic Osteoarthropathy (EOSCITPHO)

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: NCT02438709
Recruitment Status : Unknown
Verified April 2015 by Peking Union Medical College Hospital.
Recruitment status was:  Recruiting
First Posted : May 8, 2015
Last Update Posted : May 8, 2015
Sponsor:
Information provided by (Responsible Party):
Peking Union Medical College Hospital

Brief Summary:
The purpose of this study is to determine whether COX-2 inhibitor is effective in the treatment of primary hypertrophic osteoarthropathy

Condition or disease Intervention/treatment Phase
Primary Hypertrophic Osteoarthropathy Drug: COX-2 inhibitor Phase 3

Detailed Description:
Patients with primary hypertrophic osteoarthropathy(PHO) were diagnosed based on clinical manifestations and symptoms. PHO patients were treated with COX-2 inhibitor after signing informed consent. The extend of alleviation, the change of the markers on prostaglandin E metabolic pathway and the adverse event on different time points were recorded to identify the efficacy and safety.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Application of COX-2 Inhibitor for Treatment of Primary Hypertrophic Osteoarthropathy
Study Start Date : December 2012
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: COX-2 Inhibitor
Patients who take COX-2 inhibitor
Drug: COX-2 inhibitor
oral COX-2 inhibitor intake 60mg qd
Other Name: EtoriCoxib




Primary Outcome Measures :
  1. Prostaglandin E2(PGE2) level change after COX-2 inhibitor treatment in PHO patients [ Time Frame: 3 months ]
    measure the serum prostaglandin E2 level at 3 months

  2. Prostaglandin E2(PGE2) level change after COX-2 inhibitor treatment in PHO [ Time Frame: 6 months ]
    measure the serum prostaglandin E2 level at 6 months


Secondary Outcome Measures :
  1. change in pain on VAS scale after COX-2 inhibitor treatment [ Time Frame: 3 months ]
    use Visual Analogue Score (VAS) to evaluate pain

  2. change in pain on VAS scale after COX-2 inhibitor treatment [ Time Frame: 6 months ]
  3. change in pain on VAS scale after COX-2 inhibitor treatment [ Time Frame: 12 months ]
  4. The volume of distal part of middle finger change after COX-2 inhibitor treatment [ Time Frame: 3 months ]
    Both left and right fingers were measured twice and the average value was defined as volume of distal part of middle finger

  5. The volume of distal part of middle finger change after COX-2 inhibitor treatment [ Time Frame: 6 months ]
    Both left and right fingers were measured twice and the average value was defined as volume of distal part of middle finger

  6. The volume of distal part of middle finger change after COX-2 inhibitor treatment [ Time Frame: 12 months ]
    Both left and right fingers were measured twice and the average value was defined as volume of distal part of middle finger

  7. Circumference of knee joint change after COX-2 inhibitor treatment [ Time Frame: 3 months ]
    During the circumference of knee joint (CKJ) assessment, the patient was standing straight and the knee was extended as much as possible. The tester stood closest to the examined leg and used a tape to measure the circumference just at the base of the patella. Both legs were measured twice and the average value was used as CKJ.

  8. Circumference of knee joint change after COX-2 inhibitor treatment [ Time Frame: 6 months ]
    During the circumference of knee joint (CKJ) assessment, the patient was standing straight and the knee was extended as much as possible. The tester stood closest to the examined leg and used a tape to measure the circumference just at the base of the patella. Both legs were measured twice and the average value was used as CKJ.

  9. Circumference of knee joint change after COX-2 inhibitor treatment [ Time Frame: 12 months ]
    During the circumference of knee joint (CKJ) assessment, the patient was standing straight and the knee was extended as much as possible. The tester stood closest to the examined leg and used a tape to measure the circumference just at the base of the patella. Both legs were measured twice and the average value was used as CKJ.



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:   16 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • diagnosed with primary hypertrophic osteoarthropathy clinically
  • over 16 years old
  • no other medication intake
  • informed consent signed

Exclusion Criteria:

  • below 16 years old
  • active gastric ulcer
  • inflammatory bowel disease
  • New York Heart Association classification(NYHA) II to IV
  • liver or renal failure
  • allergic to nonsteroid anti-inflammatory drugs
  • not willing to participate

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): NCT02438709


Contacts
Layout table for location contacts
Contact: Weibo Xia, MD 86-10-6915-5076 xiaweibo@medmail.com.cn

Locations
Layout table for location information
China, Beijing
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 100005
Contact: Weibo Xia, MD    86-10-6915-5076    xiaweibo@medmail.com.cn   
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
Layout table for investigator information
Study Chair: Weibo Xia, MD Department of Endocrinology, Key Laboratory of Endocrinology, Ministry of Health, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences
Layout table for additonal information
Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT02438709    
Other Study ID Numbers: 81170805,2008ZX09312-016
First Posted: May 8, 2015    Key Record Dates
Last Update Posted: May 8, 2015
Last Verified: April 2015
Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoarthropathy, Primary Hypertrophic
Osteoarthropathy, Secondary Hypertrophic
Hypertrophy
Pathological Conditions, Anatomical
Bone Diseases
Musculoskeletal Diseases
Joint Diseases
Genetic Diseases, Inborn
Etoricoxib
Cyclooxygenase 2 Inhibitors
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 Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action