NCT02438709

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2012

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

January 8, 2015

Completed
4 months until next milestone

First Posted

Study publicly available on registry

May 8, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

May 8, 2015

Status Verified

April 1, 2015

Enrollment Period

2.6 years

First QC Date

January 8, 2015

Last Update Submit

May 5, 2015

Conditions

Primary Hypertrophic Osteoarthropathy

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (9)

  • change in pain on VAS scale after COX-2 inhibitor treatment

    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

    3 months

  • The volume of distal part of middle finger change after COX-2 inhibitor treatment

    6 months

  • +4 more secondary outcomes

Study Arms (1)

COX-2 Inhibitor

EXPERIMENTAL

Patients who take COX-2 inhibitor

Drug: COX-2 inhibitor

Interventions

COX-2 inhibitorDRUG

oral COX-2 inhibitor intake 60mg qd

Also known as: EtoriCoxib
COX-2 Inhibitor

Eligibility Criteria

Age16 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • diagnosed with primary hypertrophic osteoarthropathy clinically
  • over 16 years old
  • no other medication intake
  • informed consent signed

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100005, China

RECRUITING

MeSH Terms

Conditions

Osteoarthropathy, Primary Hypertrophic

Interventions

Cyclooxygenase 2 InhibitorsEtoricoxib

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesJoint DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Cyclooxygenase InhibitorsEnzyme InhibitorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesAnti-Inflammatory Agents, Non-SteroidalAnalgesics, Non-NarcoticAnalgesicsSensory System AgentsPeripheral Nervous System AgentsPhysiological Effects of DrugsAnti-Inflammatory AgentsTherapeutic UsesAntirheumatic AgentsSulfonesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • 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 CHAIR

Central Study Contacts

Weibo Xia, MD

CONTACT

86-10-6915-5076xiaweibo@medmail.com.cn

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2015

First Posted

May 8, 2015

Study Start

December 1, 2012

Primary Completion

July 1, 2015

Study Completion

July 1, 2016

Last Updated

May 8, 2015

Record last verified: 2015-04

Locations

CN(1)