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

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

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

Study Overview

• Status: Unknown
• Conditions: Primary Hypertrophic Osteoarthropathy
• Intervention / Treatment: Drug: COX-2 inhibitor

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100005
      • Recruiting
      • Peking Union Medical College Hospital
      • Contact: Weibo Xia, MD; Phone Number: 86-10-6915-5076; Email: xiaweibo@medmail.com.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 40 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: COX-2 Inhibitor; Patients who take COX-2 inhibitor	Drug: COX-2 inhibitor; oral COX-2 inhibitor intake 60mg qd; Other Names: EtoriCoxib

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Study Chair: Weibo Xia, MD, Department of Endocrinology, Key Laboratory of Endocrinology, Ministry of Health, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Anticipated): July 1, 2015
• Study Completion (Anticipated): July 1, 2016

Study Registration Dates

• First Submitted: January 8, 2015
• First Submitted That Met QC Criteria: May 5, 2015
• First Posted (Estimate): May 8, 2015

Study Record Updates

• Last Update Posted (Estimate): May 8, 2015
• Last Update Submitted That Met QC Criteria: May 5, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Joint Diseases; Musculoskeletal Diseases; Pathological Conditions, Anatomical; Bone Diseases; Hypertrophy; Osteoarthropathy, Secondary Hypertrophic; Osteoarthropathy, Primary Hypertrophic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Etoricoxib; Cyclooxygenase 2 Inhibitors
• Other Study ID Numbers: 81170805，2008ZX09312-016