Primary Hypertrophic Osteoarthropathy
Conditions
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.
Interventions
DRUGCOX-2 inhibitor
oral COX-2 inhibitor intake 60mg qd
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| change in pain on VAS scale after COX-2 inhibitor treatment | 3 months | use Visual Analogue Score (VAS) to evaluate pain |
| The volume of distal part of middle finger change after COX-2 inhibitor treatment | 3 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 | 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. |
Countries
China
Contacts
Primary ContactWeibo Xia, MD
Outcome results
None listed