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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
History of Changes
  Purpose

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


Condition Intervention Phase
Pain
 Drug: Ibuprofen
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Orion Corporation, Orion Pharma:

Primary Outcome Measures:
  • Efficacy: VAS [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
    VAS pain score change over time from baseline to day 7


Secondary Outcome Measures:
  • 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


Enrollment: 62
Study Start Date: February 2012
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ibuprofen Drug: Ibuprofen
3 times a day
Placebo Comparator: Placebo Drug: Placebo
3 times a day

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01562717

Locations
Finland
Terveystalo Lahti
Lahti, Finland
Sponsors and Collaborators
Orion Corporation, Orion Pharma
Investigators
Principal Investigator: Juha-Pekka Kaukonen, MD Terveystalo Lahti
  More Information

No publications provided

Responsible Party: Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier: NCT01562717     History of Changes
Other Study ID Numbers: 0028022, 2011-004497-28
Study First Received: March 22, 2012
Last Updated: May 7, 2013
Health Authority: Finland: Finnish Medicines Agency
Lithuania: State Medicine Control Agency - Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Additional relevant MeSH terms:
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
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 22, 2013