Efficacy and Safety of Ibuprofen in Patients With Ankle Injuries

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier:
NCT01562717
First received: March 22, 2012
Last updated: May 7, 2013
Last verified: October 2012

March 22, 2012
May 7, 2013
February 2012
October 2012   (final data collection date for primary outcome measure)
Efficacy: VAS [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
VAS pain score change over time from baseline to day 7
Same as current
Complete list of historical versions of study NCT01562717 on ClinicalTrials.gov Archive Site
Efficacy: VAS [ Time Frame: Day 3 and Day 7 ] [ Designated as safety issue: No ]
Percentage VAS pain score change from baseline separately to day 3 and 7
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of Ibuprofen in Patients With Ankle Injuries
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

The objective of the study is to evaluate the efficacy and safety of Ibuprofen in patients with ankle injuries.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Pain
  • Drug: Ibuprofen
    3 times a day
  • Drug: Placebo
    3 times a day
  • Experimental: Ibuprofen
    Intervention: Drug: Ibuprofen
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
62
October 2012
October 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT01562717
0028022, 2011-004497-28
No
Orion Corporation, Orion Pharma
Orion Corporation, Orion Pharma
Not Provided
Principal Investigator: Juha-Pekka Kaukonen, MD Terveystalo Lahti
Orion Corporation, Orion Pharma
October 2012

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