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

Primary Hypertrophic Osteoarthropathy Clinical Trial

— EOSCITPHO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02438709
• Other study ID #: 81170805,2008ZX09312-016
• Status: Recruiting
• Phase: Phase 3
• First received: January 8, 2015
• Last updated: May 5, 2015
• Start date: December 2012
• Est. completion date: July 2016

Study information

• Verified date: April 2015
• Source: Peking Union Medical College Hospital
• Contact: Weibo Xia, MD
• Phone: 86-10-6915-5076
• Email: xiaweibo[@]medmail.com.cn
• Is FDA regulated: No
• Health authority: China: National Health and Family Planning Commission
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 2016
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years to 40 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertrophy
• Osteoarthropathy, Primary Hypertrophic
• Primary Hypertrophic Osteoarthropathy

Intervention

Drug:
• COX-2 inhibitor
oral COX-2 inhibitor intake 60mg qd

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prostaglandin E2(PGE2) level change after COX-2 inhibitor treatment in PHO patients	measure the serum prostaglandin E2 level at 3 months	3 months	No
Primary	Prostaglandin E2(PGE2) level change after COX-2 inhibitor treatment in PHO	measure the serum prostaglandin E2 level at 6 months	6 months	No
Secondary	change in pain on VAS scale after COX-2 inhibitor treatment	use Visual Analogue Score (VAS) to evaluate pain	3 months	No
Secondary	change in pain on VAS scale after COX-2 inhibitor treatment		6 months	No
Secondary	change in pain on VAS scale after COX-2 inhibitor treatment		12 months	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No