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Efficacy and Safety of Ibuprofen in Patients With Ankle Injuries

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ClinicalTrials.gov Identifier: NCT01563289
Recruitment Status : Completed
First Posted : March 26, 2012
Last Update Posted : May 8, 2013
Sponsor:
Information provided by (Responsible Party):
Orion Corporation, Orion Pharma

Study Description
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Brief Summary:
The objective of the study is to evaluate the efficacy and safety of Ibuprofen in patients with ankle injuries.

Condition or disease Intervention/treatment Phase
Pain Drug: Ibuprofen Drug: Placebo Phase 3

Detailed Description:
The objective of the study is to evaluate the efficacy and safety of Ibuprofen versus placebo in patients for the treatment of pain related to uncomplicated ankle injuries.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised, Multicentre, Two-arm, Parallel Group, Double-blind, Placebo-controlled, Comparative Efficacy and Safety Clinical Study of Ibuprofen in Patients With Pain Related to Uncomplicated Ankle Injuries
Study Start Date : February 2012
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

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Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: placebo Drug: Placebo
3 times a day
Experimental: Ibuprofen Drug: Ibuprofen
3 times a day


Outcome Measures
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Primary Outcome Measures :
  1. Efficacy: visual analog scale (VAS) [ Time Frame: Day 7 ]
    VAS pain score change over time from baseline to day 7


Secondary Outcome Measures :
  1. Efficacy: VAS [ Time Frame: Day 3 and Day 7 ]
    Percentage VAS pain score change from baseline separately to day 3 and 7


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Written informed consent obtained.
  2. Male and female patients, age in the range of 18-45 years (inclusive).
  3. Patients with pain related to uncomplicated ankle injuries (in case of doubt whether it is complicated an X-ray should be taken).
  4. Pain related to ankle injuries is scored as moderate or severe by the patient and the injury is less than 24 hours old.
  5. Patients with normal or clinically non-significant findings as determined by baseline history, physical examination and vital signs (blood pressure, heart rate and axillary temperature).
  6. Comprehension of the nature and purpose of the study and compliance with the protocol requirements.
  7. Negative urine pregnancy test (for females only).

Exclusion Criteria:

  1. Known hypersensitivity to aspirin or any non-steroidal anti-inflammatory drugs (NSAID).
  2. Known history of asthma.
  3. Known history of gastric or peptic ulcer or bleeding.
  4. Known history of malignancy or other serious diseases.
  5. Known history of skin allergy.
  6. Known history of cardiac, renal or hepatic insufficiency.
  7. Presence of bruises or rash on the skin of ankle.
  8. Presence of skin lesions like eczema or psoriasis.
  9. Arthritis in the same joint.
  10. Alcohol use during the study period or within 48 hours before the study enrolment.
  11. Patients judged unable to use the VAS for pain reliably
  12. Locally applied NSAID to the painful region/area of study or oral use of NSAID or other analgesics 48 hours before the study enrolment.
  13. Other pain killers than rescue medication to be taken during the study.
  14. Recurrent sprain at the same joint during the last 6 months.
  15. Anticoagulant therapy.
  16. Physiotherapy during study period.
  17. Open wounds, infected skin or fracture.
  18. Any other condition that in the opinion of the investigator would interfere with the evaluation of the results or constitute a health risk for the patient.
  19. Pregnant or lactating females.
  20. Participation in a drug or device study within 90 days before the study enrolment.
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT01563289


Locations
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Finland
Terveystalo Lahti
Lahti, Finland
Sponsors and Collaborators
Orion Corporation, Orion Pharma
Investigators
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Principal Investigator: Juha-Pekka Kaukonen, MD Terveystalo Lahti
More Information
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Responsible Party: Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier: NCT01563289    
Other Study ID Numbers: 0028021
2011-004496-37 ( EudraCT Number )
First Posted: March 26, 2012    Key Record Dates
Last Update Posted: May 8, 2013
Last Verified: September 2012
Additional relevant MeSH terms:
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Ankle Injuries
Leg Injuries
Wounds and Injuries
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action