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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

Tracking Information
First Submitted Date  ICMJE March 22, 2012
First Posted Date  ICMJE March 26, 2012
Last Update Posted Date May 8, 2013
Study Start Date  ICMJE February 2012
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 23, 2012)
Efficacy: visual analog scale (VAS) [ Time Frame: Day 7 ]
VAS pain score change over time from baseline to day 7
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2012)
Efficacy: VAS [ Time Frame: Day 3 and Day 7 ]
Percentage VAS pain score change from baseline separately to day 3 and 7
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Ibuprofen in Patients With Ankle Injuries
Official Title  ICMJE 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
Brief Summary The objective of the study is to evaluate the efficacy and safety of Ibuprofen in patients with ankle injuries.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Pain
Intervention  ICMJE
  • Drug: Ibuprofen
    3 times a day
  • Drug: Placebo
    3 times a day
Study Arms  ICMJE
  • Placebo Comparator: placebo
    Intervention: Drug: Placebo
  • Experimental: Ibuprofen
    Intervention: Drug: Ibuprofen
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 23, 2012)
62
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2012
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01563289
Other Study ID Numbers  ICMJE 0028021
2011-004496-37 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Orion Corporation, Orion Pharma
Study Sponsor  ICMJE Orion Corporation, Orion Pharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Juha-Pekka Kaukonen, MD Terveystalo Lahti
PRS Account Orion Corporation, Orion Pharma
Verification Date September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP