Clinical trial NCT01563289: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Lead sponsor: Orion Corporation, Orion Pharma
Sponsor class: INDUSTRY
First posted: 2012-03-26
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Efficacy: visual analog scale (VAS)
timeFrame: Day 7
Secondary outcomes:
measure: Efficacy: VAS
timeFrame: Day 3 and Day 7
Other outcomes:
Locations:
city: Lahti
country: Finland
facility: Terveystalo Lahti
Study officials:
affiliation: Terveystalo Lahti
name: Juha-Pekka Kaukonen, MD
role: PRINCIPAL_INVESTIGATOR
References: