- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00444808
Analgesic Effect of Intranasal Calcitonin on Patients With Fractured Ribs
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Quebec
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Montréal, Quebec, Canada, H4J 1C5
- Hopital du Sacre-Coeur
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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)
- Steroid use within the past month
- Pregnancy, breast feeding
- Non-availability of patient for telephone follow-ups or follow-up appointments.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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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.
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and/or reduction the use of back-up medication on days 1, 3, 7, 14, 21, 28.
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Secondary Outcome Measures
Outcome Measure |
---|
Improvement in the quality of life and sleep.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Raoul Daoust, MD, Centre de Recherche Hopital du Sacre-Coeur de Montreal
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- C.E. 2004-11-77
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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