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

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

Detailed Description
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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.

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

Conditions
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Primary Hypertrophic Osteoarthropathy

Intervention / Treatment
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* Drug: COX-2 inhibitor


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: COX-2 Inhibitor<br>Patients who take COX-2 inhibitor | Drug: COX-2 inhibitor<br>* oral COX-2 inhibitor intake 60mg qd<br>* Other names: EtoriCoxib;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prostaglandin E2（PGE2） level change after COX-2 inhibitor treatment in PHO patients | measure the serum prostaglandin E2 level at 3 months | 3 months | 
| Prostaglandin E2（PGE2） level change after COX-2 inhibitor treatment in PHO | measure the serum prostaglandin E2 level at 6 months | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in pain on VAS scale after COX-2 inhibitor treatment | use Visual Analogue Score (VAS) to evaluate pain | 3 months | 
| change in pain on VAS scale after COX-2 inhibitor treatment |  | 6 months | 
| 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 | Both left and right fingers were measured twice and the average value was defined as volume of distal part of middle finger | 3 months | 
| The volume of distal part of middle finger change after COX-2 inhibitor treatment | Both left and right fingers were measured twice and the average value was defined as volume of distal part of middle finger | 6 months | 
| The volume of distal part of middle finger change after COX-2 inhibitor treatment | Both left and right fingers were measured twice and the average value was defined as volume of distal part of middle finger | 12 months | 
| Circumference of knee joint change after COX-2 inhibitor treatment | 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. | 3 months | 
| Circumference of knee joint change after COX-2 inhibitor treatment | 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. | 6 months | 
| Circumference of knee joint change after COX-2 inhibitor treatment | 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. | 12 months |