ParecoxibPhase 3NCT02749409
Early Parecoxib Usage to Decreases Narcotic Requirement and Length of Stay After Traumatic Rib Fracture
A Phase 3 study testing Parecoxib and Morphine in people with Parecoxib and Rib Fractures, run by Chang Gung Memorial Hospital.
Trial summary
Patients diagnosed traumatic rib fracture and need admission will be included. Patients will be divided two groups.The experimental group will be given parecoxib after visiting emergency department. The control group will be given Narcotic agent such as morphine for pain control. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parecoxib, Rib Fractures
- What is being tested?
- Parecoxib and Morphine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- No sites listed yet
- Study dates
- 8 Aug 2016to 20 Jul 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Investigators will prospective enroll patients who are diagnosed chest trauma with rib fractures
- Age ≧18 y/o
Who cannot join
- Patients who have history of heart failure, CAD history.
- Traumatic cardiac injury and cardiac tamponade
- History of allergy effect for Cyclooxygenase 2 (COX2) inhibitor or NSAID
About this study
Patients diagnosed traumatic rib fracture and need admission will be included. Patients will be divided two groups.The experimental group will be given parecoxib after visiting emergency department. The control group will be given Narcotic agent such as morphine for pain control. The outcome such as numerical rating scale (NRS) and hospital length of stay will be recorded.
Read the detailed description
3.1 Inclusion/exclusion criteria Patients who are diagnosed ribs fracture and need admission. Exclusion criteria included heart failure, Coronary artery disease (CAD) history. Traumatic cardiac injury and cardiac tamponade will be excluded, too.
3.2 Group design Patients will be divided two groups, and the experimental group will be given parecoxib after visiting emergency department. And they will be kept given after admission by intravenous method every 12 hours for 4 days. The control group will be given Narcotic agent such as morphine for pain control. The daily dose will be recorded. Finally the end outcome will be recorded.
3.3 Data collection The data of patient's medical history and laboratory results will be recorded on pre-designed case report forms (CRFs) by study nurses. In all patients, age, gender, diagnosis, co-morbidities, length of hospital and intensive care unit (ICU) stay, Injury Severity Score (ISS) score, numerical rating scale (NRS) and outcomes, will be recorded. In addition, all microorganisms isolated and antibiotic substances applied will be documented.
- Conditions
- Parecoxib, Rib Fractures
- Being tested
- Parecoxib, Morphine
- Medical subject headings
- Rib Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParecoxibDrug
MorphineDrug
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | The control group will be given Morphine prn after admission Receives: Drug: Morphine |
| Experimental group | Experimental | the experimental group will be given parecoxib after admission by intravenous method every 12 hours for 4 days. Then Morphine agent will be given prn usage Receives: Drug: Parecoxib |
What is being measured
The primary outcome is the main question the study is designed to answer.
all cause mortality
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2016 (estimated)
- Study start8 Aug 2016
- Primary completion10 Jul 2018
- Study completion20 Jul 2018
Why it stopped: Case numbers not enough, however, the funding is over
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParecoxibStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02749409
- Sponsor's protocol ID
- PARECOXIB RIB
- Status last verified
- Jul 2016
- First submitted
- 7 Apr 2016
- Last updated
- 31 Jan 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Parecoxib Usage to Decreases Narcotic Requirement and Length of Stay After Traumatic Rib Fracture
- ClinicalTrials.gov ID
- NCT02749409
- Acronym / sponsor ID
- PARECOXIB RIB
- Conditions
- Parecoxib, Rib Fractures
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Case numbers not enough, however, the funding is over
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 8 Aug 2016 (actual)
- Primary completion
- 10 Jul 2018 (actual)
- Study completion
- 20 Jul 2018 (actual)
- First posted
- 25 Apr 2016 (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.
Patients diagnosed traumatic rib fracture and need admission will be included. Patients will be divided two groups.The experimental group will be given parecoxib after visiting emergency department. The control group will be given Narcotic agent such as morphine for pain control. The outcome such as numerical rating scale (NRS) and hospital length of stay will be recorded.
Detailed description
3.1 Inclusion/exclusion criteria Patients who are diagnosed ribs fracture and need admission. Exclusion criteria included heart failure, Coronary artery disease (CAD) history. Traumatic cardiac injury and cardiac tamponade will be excluded, too.
3.2 Group design Patients will be divided two groups, and the experimental group will be given parecoxib after visiting emergency department. And they will be kept given after admission by intravenous method every 12 hours for 4 days. The control group will be given Narcotic agent such as morphine for pain control. The daily dose will be recorded. Finally the end outcome will be recorded.
3.3 Data collection The data of patient's medical history and laboratory results will be recorded on pre-designed case report forms (CRFs) by study nurses. In all patients, age, gender, diagnosis, co-morbidities, length of hospital and intensive care unit (ICU) stay, Injury Severity Score (ISS) score, numerical rating scale (NRS) and outcomes, will be recorded. In addition, all microorganisms isolated and antibiotic substances applied will be documented.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Drug: MorphineThe control group will be given Morphine prn after admission |
| Experimental group | Experimental | Drug: Parecoxibthe experimental group will be given parecoxib after admission by intravenous method every 12 hours for 4 days. Then Morphine agent will be given prn usage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Investigators will prospective enroll patients who are diagnosed chest trauma with rib fractures
- Age ≧18 y/o
Key exclusion criteria (3 listed)
- Patients who have history of heart failure, CAD history.
- Traumatic cardiac injury and cardiac tamponade
- History of allergy effect for Cyclooxygenase 2 (COX2) inhibitor or NSAID
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 |
|---|---|---|
| Parecoxib | Drug | Experimental group |
| Morphine | Drug | Control group |
Primary outcome
all cause mortality
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Case numbers not enough, however, the funding is over). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Parecoxib and Morphine in people with Parecoxib and Rib Fractures, run by Chang Gung Memorial Hospital.
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 2 inclusion and 3 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: stopped early, as of the sponsor's last update on 31 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was stopped early (reason given: Case numbers not enough, however, the funding is over). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all cause mortality (time frame: 1 year). 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 31 Jan 2020.