Efficacy and Safety of Ibuprofen in Patients With Ankle Injuries

Orion Pharma

Status and phase: Completed; Phase 3

Conditions: Pain

Treatments: Drug: Placebo; Drug: Ibuprofen

Study type: Interventional

Funder types: Industry

Identifiers

NCT01562717

2011-004497-28 (EudraCT Number)

0028022

Details and patient eligibility

About

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

Full 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.

Enrollment: 62 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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62 participants in 2 patient groups, including a placebo group

Ibuprofen

Experimental group

Treatment:

Drug: Ibuprofen

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo