Efficacy and Safety of Ibuprofen in Patients With Ankle Injuries

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

Tracking Information

• First Submitted Date: March 22, 2012
• First Posted Date: March 26, 2012
• Last Update Posted Date: May 8, 2013
• Study Start Date: February 2012
• Actual Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Efficacy and Safety of Ibuprofen in Patients With Ankle Injuries
• 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
• 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Pain

Intervention

• Drug: Ibuprofen
  3 times a day
• Drug: Placebo
  3 times a day

Study Arms

• Placebo Comparator: placebo
  Intervention: Drug: Placebo
• Experimental: Ibuprofen
  Intervention: Drug: Ibuprofen

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 23, 2012): 62
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: July 2012
• Actual Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 45 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Finland

Administrative Information

• NCT Number: NCT01563289
• Other Study ID Numbers: 0028021; 2011-004496-37 ( EudraCT Number )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Orion Corporation, Orion Pharma
• Study Sponsor: Orion Corporation, Orion Pharma
• Collaborators: Not Provided

Investigators

• Principal Investigator: Juha-Pekka Kaukonen, MD; Terveystalo Lahti

• PRS Account: Orion Corporation, Orion Pharma
• Verification Date: September 2012