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Trial record 21 of 231 for:    CALCITONIN SALMON

Analgesic Effect of Intranasal Calcitonin on Patients With Fractured Ribs

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00444808
Recruitment Status : Terminated (Medication expired)
First Posted : March 8, 2007
Last Update Posted : June 4, 2008
Information provided by:
Université de Montréal

Brief 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 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®).

Condition or disease Intervention/treatment Phase
Rib Fractures Pain Drug: Intranasal calcitonin Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Analgesic Effect of Intranasal Calcitonin on Patients With Fractured Ribs
Study Start Date : February 2007
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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.
  2. and/or reduction the use of back-up medication on days 1, 3, 7, 14, 21, 28.

Secondary Outcome Measures :
  1. Improvement in the quality of life and sleep.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00444808

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Canada, Quebec
Hôpital du Sacré-Coeur
Montréal, Quebec, Canada, H4J 1C5
Sponsors and Collaborators
Université de Montréal
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Principal Investigator: Raoul Daoust, MD Centre de recherche hôpital du Sacré-Coeur de Montréal

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Responsible Party: Raoul Daoust, University of Montreal Identifier: NCT00444808     History of Changes
Other Study ID Numbers: C.E. 2004-11-77
First Posted: March 8, 2007    Key Record Dates
Last Update Posted: June 4, 2008
Last Verified: June 2008
Keywords provided by Université de Montréal:
Rib fracture
intranasal calcitonin
Additional relevant MeSH terms:
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Salmon calcitonin
Calcitonin Gene-Related Peptide
Rib Fractures
Fractures, Bone
Wounds and Injuries
Thoracic Injuries
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Calcium-Regulating Hormones and Agents
Bone Density Conservation Agents
Vasodilator Agents