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

NCT ID: NCT02438709

Last Updated: 2015-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2016-07-31

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.

Conditions

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Primary Hypertrophic Osteoarthropathy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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COX-2 Inhibitor

Patients who take COX-2 inhibitor

Group Type EXPERIMENTAL

COX-2 inhibitor

Intervention Type DRUG

oral COX-2 inhibitor intake 60mg qd

Interventions

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COX-2 inhibitor

oral COX-2 inhibitor intake 60mg qd

Intervention Type DRUG

Other Intervention Names

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EtoriCoxib

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
Minimum Eligible Age

16 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Weibo Xia, MD

Role: STUDY_CHAIR

Department of Endocrinology, Key Laboratory of Endocrinology, Ministry of Health, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences

Locations

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Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Weibo Xia, MD

Role: CONTACT

86-10-6915-5076

Facility Contacts

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Weibo Xia, MD

Role: primary

86-10-6915-5076

Other Identifiers

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81170805,2008ZX09312-016

Identifier Type: -

Identifier Source: org_study_id

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