Clinical Trial: Effect Observation Study of COX-2 Inhibitor to Treat Primary Hypertrophic Osteoarthropathy

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Application of COX-2 Inhibitor for Treatment of Primary Hypertrophic Osteoarthropathy

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

Detailed Summary: 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.
Sponsor: Peking Union Medical College Hospital

Current Primary Outcome:

• 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
• 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

Original Primary Outcome: Same as current

Current Secondary Outcome:

• change in pain on VAS scale after COX-2 inhibitor treatment [ Time Frame: 3 months ]
  use Visual Analogue Score (VAS) to evaluate pain
• change in pain on VAS scale after COX-2 inhibitor treatment [ Time Frame: 6 months ]
• change in pain on VAS scale after COX-2 inhibitor treatment [ Time Frame: 12 months ]
• 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
• 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
• 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
• 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.
• 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.
• 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.

Original Secondary Outcome: Same as current

Information By: Peking Union Medical College Hospital

Dates:
Date Received: January 8, 2015
Date Started: December 2012
Date Completion: July 2016
Last Updated: May 5, 2015
Last Verified: April 2015