Efficacy and Safety of Ibuprofen in Patients With Ankle Injuries

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

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

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: Ibuprofen; Drug: Placebo

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
• Enrollment (Actual): 62
• Phase: Phase 3

Contacts and Locations

Study Locations

• Finland
  • Lahti, Finland
    • Terveystalo Lahti

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: placebo	Drug: Placebo; 3 times a day
EXPERIMENTAL: Ibuprofen	Drug: Ibuprofen; 3 times a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy: visual analog scale (VAS)	VAS pain score change over time from baseline to day 7	Day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy: VAS	Percentage VAS pain score change from baseline separately to day 3 and 7	Day 3 and Day 7

Collaborators and Investigators

• Sponsor: Orion Corporation, Orion Pharma

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (ACTUAL): July 1, 2012
• Study Completion (ACTUAL): July 1, 2012

Study Registration Dates

• First Submitted: March 22, 2012
• First Submitted That Met QC Criteria: March 23, 2012
• First Posted (ESTIMATE): March 26, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): May 8, 2013
• Last Update Submitted That Met QC Criteria: May 7, 2013
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Ankle Injuries; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ibuprofen
• Other Study ID Numbers: 0028021; 2011-004496-37 (EUDRACT_NUMBER)