Effect Observation Study of COX-2 Inhibitor to Treat Primary Hypertrophic Osteoarthropathy
- Conditions
- Primary Hypertrophic Osteoarthropathy
- Interventions
- Drug: COX-2 inhibitor
- Registration Number
- NCT02438709
- Lead Sponsor
- 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
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
- diagnosed with primary hypertrophic osteoarthropathy clinically
- over 16 years old
- no other medication intake
- informed consent signed
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description COX-2 Inhibitor COX-2 inhibitor Patients who take COX-2 inhibitor
- Primary Outcome Measures
Name Time Method Prostaglandin E2（PGE2） level change after COX-2 inhibitor treatment in PHO patients 3 months measure the serum prostaglandin E2 level at 3 months
Prostaglandin E2（PGE2） level change after COX-2 inhibitor treatment in PHO 6 months measure the serum prostaglandin E2 level at 6 months
- Secondary Outcome Measures
Name Time Method change in pain on VAS scale after COX-2 inhibitor treatment 12 months The volume of distal part of middle finger change after COX-2 inhibitor treatment 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 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.
Trial Locations
- Locations (1)
Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, China