Primary Hypertrophic OsteoarthropathyPhase 3EOSCITPHONCT02438709
Effect Observation Study of COX-2 Inhibitor to Treat Primary Hypertrophic Osteoarthropathy
A Phase 3 study testing COX-2 inhibitor in people with Primary Hypertrophic Osteoarthropathy, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
The purpose of this study is to determine whether COX-2 inhibitor is effective in the treatment of primary hypertrophic osteoarthropathy Read more about this study
- Who is it for?
- Ages 16 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Hypertrophic Osteoarthropathy
- What is being tested?
- COX-2 inhibitor
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Dec 2012to Jul 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- diagnosed with primary hypertrophic osteoarthropathy clinically
- over 16 years old
- no other medication intake
- informed consent signed
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100005
Weibo Xia, MD, 86-10-6915-5076, xiaweibo@medmail.com.cn
About this study
Official title: 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
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.
- Conditions
- Primary Hypertrophic Osteoarthropathy
- Being tested
- COX-2 inhibitor
- Medical subject headings
- Osteoarthropathy, Primary Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COX-2 inhibitorDrug
Also called EtoriCoxib
oral COX-2 inhibitor intake 60mg qd
| Study group | Role | What they receive |
|---|---|---|
| COX-2 Inhibitor | Experimental | Patients who take COX-2 inhibitor Receives: Drug: COX-2 inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prostaglandin E2（PGE2） level change after COX-2 inhibitor treatment in PHO patients
measure the serum prostaglandin E2 level at 3 months
Measured: 3 months
Prostaglandin E2（PGE2） level change after COX-2 inhibitor treatment in PHO
measure the serum prostaglandin E2 level at 6 months
Measured: 6 months
Secondary outcomes (9)
change in pain on VAS scale after COX-2 inhibitor treatment
use Visual Analogue Score (VAS) to evaluate pain
Measured: 3 months
change in pain on VAS scale after COX-2 inhibitor treatment
Measured: 6 months
change in pain on VAS scale after COX-2 inhibitor treatment
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2015 (estimated)
- Study startDec 2012
- Primary completionJul 2015 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Hypertrophic OsteoarthropathyStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02438709
- Sponsor's protocol ID
- 81170805，2008ZX09312-016
- Acronym
- EOSCITPHO
- Status last verified
- Apr 2015
- First submitted
- 8 Jan 2015
- Last updated
- 8 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of COX-2 Inhibitor for Treatment of Primary Hypertrophic Osteoarthropathy
- ClinicalTrials.gov ID
- NCT02438709
- Acronym / sponsor ID
- EOSCITPHO / 81170805，2008ZX09312-016
- Conditions
- Primary Hypertrophic Osteoarthropathy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 8 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COX-2 Inhibitor | Experimental | Drug: COX-2 inhibitorPatients who take COX-2 inhibitor |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- diagnosed with primary hypertrophic osteoarthropathy clinically
- over 16 years old
- no other medication intake
- informed consent signed
Key exclusion criteria (7 listed)
- below 16 years old
- active gastric ulcer
- inflammatory bowel disease
- New York Heart Association classification（NYHA） II to IV
- liver or renal failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COX-2 inhibitorAlso: EtoriCoxiboral COX-2 inhibitor intake 60mg qd | Drug | COX-2 Inhibitor |
Primary outcome
Prostaglandin E2（PGE2） level change after COX-2 inhibitor treatment in PHO patients
Time frame: 3 months
measure the serum prostaglandin E2 level at 3 months
Prostaglandin E2（PGE2） level change after COX-2 inhibitor treatment in PHO
Time frame: 6 months
measure the serum prostaglandin E2 level at 6 months
9 secondary outcomes
change in pain on VAS scale after COX-2 inhibitor treatment
Time frame: 3 months
change in pain on VAS scale after COX-2 inhibitor treatment
Time frame: 6 months
change in pain on VAS scale after COX-2 inhibitor treatment
Time frame: 12 months
The volume of distal part of middle finger change after COX-2 inhibitor treatment
Time frame: 3 months
The volume of distal part of middle finger change after COX-2 inhibitor treatment
Time frame: 6 months
The volume of distal part of middle finger change after COX-2 inhibitor treatment
Time frame: 12 months
Circumference of knee joint change after COX-2 inhibitor treatment
Time frame: 3 months
Circumference of knee joint change after COX-2 inhibitor treatment
Time frame: 6 months
Circumference of knee joint change after COX-2 inhibitor treatment
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing COX-2 inhibitor in people with Primary Hypertrophic Osteoarthropathy, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Weibo Xia, MD (86-10-6915-5076, xiaweibo@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prostaglandin E2（PGE2） level change after COX-2 inhibitor treatment in PHO patients (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2015.