Back to resultsEffect Observation Study of COX-2 Inhibitor to Treat Primary Hypertrophic Osteoarthropathy (EOSCITPHO)
Primary Purpose
Primary Hypertrophic Osteoarthropathy
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
COX-2 inhibitor
Sponsored by
About this trial
This is an interventional treatment trial for Primary Hypertrophic Osteoarthropathy
Eligibility Criteria
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
Sites / Locations
- Peking Union Medical College HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
COX-2 Inhibitor
Arm Description
Patients who take COX-2 inhibitor
Outcomes
Primary Outcome Measures
Prostaglandin E2（PGE2） level change after COX-2 inhibitor treatment in PHO patients
measure the serum prostaglandin E2 level at 3 months
Prostaglandin E2（PGE2） level change after COX-2 inhibitor treatment in PHO
measure the serum prostaglandin E2 level at 6 months
Secondary Outcome Measures
change in pain on VAS scale after COX-2 inhibitor treatment
use Visual Analogue Score (VAS) to evaluate pain
change in pain on VAS scale after COX-2 inhibitor treatment
change in pain on VAS scale after COX-2 inhibitor treatment
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
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
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
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.
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.
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.
Full Information
NCT ID
NCT02438709
First Posted
January 8, 2015
Last Updated
May 5, 2015
Sponsor
Peking Union Medical College Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02438709
Brief Title
Effect Observation Study of COX-2 Inhibitor to Treat Primary Hypertrophic Osteoarthropathy
Acronym
EOSCITPHO
Official Title
Application of COX-2 Inhibitor for Treatment of Primary Hypertrophic Osteoarthropathy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
December 2012 (undefined)
Primary Completion Date
July 2015 (Anticipated)
Study Completion Date
July 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Hypertrophic Osteoarthropathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
COX-2 Inhibitor
Arm Type
Experimental
Arm Description
Patients who take COX-2 inhibitor
Intervention Type
Drug
Intervention Name(s)
COX-2 inhibitor
Other Intervention Name(s)
EtoriCoxib
Intervention Description
oral COX-2 inhibitor intake 60mg qd
Primary Outcome Measure Information:
Title
Prostaglandin E2（PGE2） level change after COX-2 inhibitor treatment in PHO patients
Description
measure the serum prostaglandin E2 level at 3 months
Time Frame
3 months
Title
Prostaglandin E2（PGE2） level change after COX-2 inhibitor treatment in PHO
Description
measure the serum prostaglandin E2 level at 6 months
Time Frame
6 months
Secondary Outcome Measure Information:
Title
change in pain on VAS scale after COX-2 inhibitor treatment
Description
use Visual Analogue Score (VAS) to evaluate pain
Time Frame
3 months
Title
change in pain on VAS scale after COX-2 inhibitor treatment
Time Frame
6 months
Title
change in pain on VAS scale after COX-2 inhibitor treatment
Time Frame
12 months
Title
The volume of distal part of middle finger change after COX-2 inhibitor treatment
Description
Both left and right fingers were measured twice and the average value was defined as volume of distal part of middle finger
Time Frame
3 months
Title
The volume of distal part of middle finger change after COX-2 inhibitor treatment
Description
Both left and right fingers were measured twice and the average value was defined as volume of distal part of middle finger
Time Frame
6 months
Title
The volume of distal part of middle finger change after COX-2 inhibitor treatment
Description
Both left and right fingers were measured twice and the average value was defined as volume of distal part of middle finger
Time Frame
12 months
Title
Circumference of knee joint change after COX-2 inhibitor treatment
Description
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.
Time Frame
3 months
Title
Circumference of knee joint change after COX-2 inhibitor treatment
Description
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.
Time Frame
6 months
Title
Circumference of knee joint change after COX-2 inhibitor treatment
Description
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.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weibo Xia, MD
Phone
86-10-6915-5076
Email
xiaweibo@medmail.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weibo Xia, MD
Organizational Affiliation
Department of Endocrinology, Key Laboratory of Endocrinology, Ministry of Health, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100005
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weibo Xia, MD
Phone
86-10-6915-5076
Email
xiaweibo@medmail.com.cn
12. IPD Sharing Statement
Learn more about this trial
Effect Observation Study of COX-2 Inhibitor to Treat Primary Hypertrophic Osteoarthropathy
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