Rib FracturesPhase 4NCT00444808
Analgesic Effect of Intranasal Calcitonin on Patients With Fractured Ribs
A Phase 4 study testing Intranasal calcitonin in people with Rib Fractures and Pain, run by Université de Montréal at 1 site in Canada.
Trial summary
This study, which will be conducted at the emergency room of the Sacré-Cœur hospital, requires the recruitment of 60 subjects and involves some telephone follow-up. Calcitonin administered as an intranasal spray is already used to relieve pain caused by broken vertebrae and we seek to determine if it can be as… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rib Fractures, Pain
- What is being tested?
- Intranasal calcitonin
- How many people
- 19 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2007to Jan 2008
- Phase
- Phase 4
- 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
- Patients aged 18 or more.
- Accidental rib fracture (one or more) visible on a lung\thorax radiography, or on a CT Scan of the thorax, as determined by the emergency physician or the radiologist.
- The rib fracture is the main cause of pain.
- The patient says yes to the question "do you wish something for your pain" (the result of the quantitative assessment of the pain in not taken into consideration) or the patient has already received an analgesic before the initial assessment by the emergency physician.
- The patient is seen no more than 48 hours after the accident.
Who cannot join
- The patient is already receiving SC.
- Allergy or intolerance to SC, oxycodone chlorhydrate or acetaminophen
- Active neoplasia history for at least 5 years
- Toxicomania history as revealed by case history
- Osteoporosis linked to hyperparathyroidism
- Patient already using opiate analgesics or other analgesics on a regular basis (excluding aspirin at doses of 325 mg or less, as a prophylactic for cardiovascular diseases and under stable posology for at least 15 days)
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- Steroid use within the past month
- Pregnancy, breast feeding
- Non-availability of patient for telephone follow-ups or follow-up appointments.
Trial locations and contacts
1 site in 1 country.
About this study
This study, which will be conducted at the emergency room of the Sacré-Cœur hospital, requires the recruitment of 60 subjects and involves some telephone follow-up.
Calcitonin administered as an intranasal spray is already used to relieve pain caused by broken vertebrae and we seek to determine if it can be as efficient in the case of pain caused by broken ribs.This study aims at testing the hypothesis that subjects suffering from the accidental fracture of one or more ribs will get relief through the intranasal spraying of calcitonin and/or will use less opiate medication for pain relief (a combination of oxycodone chlorhydrate and acetaminophen called Percocet®).
- Conditions
- Rib Fractures, Pain
- Being tested
- Intranasal calcitonin
- Keywords
- Rib fracture, Pain, intranasal calcitonin
- Medical subject headings
- Rib Fractures, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal calcitoninDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of the pain level by 30% as measured on the visual analog scale of 0-100 mm on days 1, 3, 7, 14, 21, 28.
and/or reduction the use of back-up medication on days 1, 3, 7, 14, 21, 28.
Secondary outcomes (1)
Improvement in the quality of life and sleep.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2007 (estimated)
- Study startFeb 2007
- Study completionJan 2008
Why it stopped: Medication expired
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rib FracturesStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Montréal
- Sponsor type
- University, hospital or other
- Investigators
- Raoul Daoust, MD, Principal investigator, Centre de recherche hôpital du Sacré-Coeur de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00444808
- Sponsor's protocol ID
- C.E. 2004-11-77
- Status last verified
- Jun 2008
- First submitted
- 7 Mar 2007
- Last updated
- 4 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Effect of Intranasal Calcitonin on Patients With Fractured Ribs
- ClinicalTrials.gov ID
- NCT00444808
- Acronym / sponsor ID
- C.E. 2004-11-77
- Conditions
- Rib Fractures, Pain
- Keywords
- Rib fracture, Pain, intranasal calcitonin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Medication expired
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Université de MontréalUniversity, hospital or other
- Study start
- Feb 2007
- Study completion
- Jan 2008 (actual)
- First posted
- 8 Mar 2007 (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.
This study, which will be conducted at the emergency room of the Sacré-Cœur hospital, requires the recruitment of 60 subjects and involves some telephone follow-up.
Calcitonin administered as an intranasal spray is already used to relieve pain caused by broken vertebrae and we seek to determine if it can be as efficient in the case of pain caused by broken ribs.This study aims at testing the hypothesis that subjects suffering from the accidental fracture of one or more ribs will get relief through the intranasal spraying of calcitonin and/or will use less opiate medication for pain relief (a combination of oxycodone chlorhydrate and acetaminophen called Percocet®).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged 18 or more.
- Accidental rib fracture (one or more) visible on a lung\thorax radiography, or on a CT Scan of the thorax, as determined by the emergency physician or the radiologist.
- The rib fracture is the main cause of pain.
- The patient says yes to the question "do you wish something for your pain" (the result of the quantitative assessment of the pain in not taken into consideration) or the patient has already received an analgesic before the initial assessment by the emergency physician.
- The patient is seen no more than 48 hours after the accident.
Key exclusion criteria (9 listed)
- The patient is already receiving SC.
- Allergy or intolerance to SC, oxycodone chlorhydrate or acetaminophen
- Active neoplasia history for at least 5 years
- Toxicomania history as revealed by case history
- Osteoporosis linked to hyperparathyroidism
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 |
|---|---|---|
| Intranasal calcitonin | Drug | – |
Primary outcome
Reduction of the pain level by 30% as measured on the visual analog scale of 0-100 mm on days 1, 3, 7, 14, 21, 28.
and/or reduction the use of back-up medication on days 1, 3, 7, 14, 21, 28.
1 secondary outcome
Improvement in the quality of life and sleep.
Results and safety
The study was stopped early (reason given: Medication expired). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2008.
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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.
Raoul Daoust, MD principal investigator
Centre de recherche hôpital du Sacré-Coeur de Montréal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intranasal calcitonin in people with Rib Fractures and Pain, run by Université de Montréal at 1 site in Canada.
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 5 inclusion and 9 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 4 Jun 2008. 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 Canada. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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: Medication expired). 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?
Reduction of the pain level by 30% as measured on the visual analog scale of 0-100 mm on days 1, 3, 7, 14, 21, 28.. 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 4 Jun 2008.