Efficacy and Safety of Ibuprofen in Patients With Ankle Injuries

NCT ID: NCT01563289

Last Updated: 2013-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2012-07-31

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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

3 times a day

Ibuprofen

Group Type: EXPERIMENTAL

Ibuprofen

Intervention Type: DRUG

3 times a day

Interventions

Ibuprofen

3 times a day

Intervention Type: DRUG

Placebo

3 times a day

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Orion Corporation, Orion Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Juha-Pekka Kaukonen, MD

Role: PRINCIPAL_INVESTIGATOR

Terveystalo Lahti

Locations

Terveystalo Lahti

Lahti, , Finland

Countries

Finland

Other Identifiers

2011-004496-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

0028021

Identifier Type: -

Identifier Source: org_study_id