CClinicalTrials.gg
Status unknownNCT02438709EOSCITPHOUpdated May 8, 2015

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

A Phase 3 interventional study of COX-2 inhibitor in Primary Hypertrophic Osteoarthropathy, sponsored by Peking Union Medical College Hospital. Status unknown at 1 site in China. Open to participants aged 16 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-05-08.

Sponsored by Peking Union Medical College Hospital · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2015), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
16 Years to 40 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Primary Hypertrophic Osteoarthropathy

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03

In context

Hypertrophy

656 studies on the registry are indexed under Hypertrophy; 87 are open to participants now.

This study's planned enrollment of 30 is below the median of 50 across 460 interventional studies indexed under Hypertrophy.

Browse Hypertrophy studies →

Lead sponsor

Peking Union Medical College Hospital is the lead sponsor of 1,115 studies on the registry; 463 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    COX-2 Inhibitor

    Patients who take COX-2 inhibitor

    Drug: COX-2 inhibitor

Interventions

  • DrugCOX-2 inhibitor

    oral COX-2 inhibitor intake 60mg qd

    Also known as: EtoriCoxib

06

What researchers measure

Primary outcomes

  1. Prostaglandin E2(PGE2) level change after COX-2 inhibitor treatment in PHO patients

    measure the serum prostaglandin E2 level at 3 months

    Time frame: 3 months

  2. Prostaglandin E2(PGE2) level change after COX-2 inhibitor treatment in PHO

    measure the serum prostaglandin E2 level at 6 months

    Time frame: 6 months

Secondary outcomes

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

    use Visual Analogue Score (VAS) to evaluate pain

    Time frame: 3 months

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

    Time frame: 6 months

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

    Time frame: 12 months

  4. 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

    Time frame: 3 months

  5. 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

    Time frame: 6 months

  6. 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

    Time frame: 12 months

  7. 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.

    Time frame: 3 months

  8. 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.

    Time frame: 6 months

  9. 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.

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
  • Peking Union Medical College Hospital
    Beijing, Beijing 100005, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 8, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02438709
Lead sponsor
Peking Union Medical College Hospital
Responsible party
Sponsor
First posted
May 8, 2015
Start date
Dec 2012
Primary completion
Jul 2015 (estimated)
Completion
Jul 2016 (estimated)
Last update
May 8, 2015

Study contacts

Weibo Xia, MD
Contact
xiaweibo@medmail.com.cn
86-10-6915-5076
Weibo Xia, MD
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

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

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