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Efficacy and Safety of Ibuprofen in Patients With Ankle Injuries

Primary Purpose

Pain

Status

Completed

Phase

Phase 3

Locations

Finland

Study Type

Interventional

Intervention

Ibuprofen

Placebo

About this trial

This is an interventional treatment trial for Pain

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Written informed consent obtained.
Male and female patients, age in the range of 18-45 years (inclusive).
Patients with pain related to uncomplicated ankle injuries (in case of doubt whether it is complicated an X-ray should be taken).
Pain related to ankle injuries is scored as moderate or severe by the patient and the injury is less than 24 hours old.
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).
Comprehension of the nature and purpose of the study and compliance with the protocol requirements.
Negative urine pregnancy test (for females only).

Exclusion Criteria:

Known hypersensitivity to aspirin or any non-steroidal anti-inflammatory drugs (NSAID).
Known history of asthma.
Known history of gastric or peptic ulcer or bleeding.
Known history of malignancy or other serious diseases.
Known history of skin allergy.
Known history of cardiac, renal or hepatic insufficiency.
Presence of bruises or rash on the skin of ankle.
Presence of skin lesions like eczema or psoriasis.
Arthritis in the same joint.
Alcohol use during the study period or within 48 hours before the study enrolment.
Patients judged unable to use the VAS for pain reliably
Locally applied NSAID to the painful region/area of study or oral use of NSAID or other analgesics 48 hours before the study enrolment.
Other pain killers than rescue medication to be taken during the study.
Recurrent sprain at the same joint during the last 6 months.
Anticoagulant therapy.
Physiotherapy during study period.
Open wounds, infected skin or fracture.
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.
Pregnant or lactating females.
Participation in a drug or device study within 90 days before the study enrolment.

Sites / Locations

Terveystalo Lahti

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ibuprofen

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Efficacy: VAS

VAS pain score change over time from baseline to day 7

Secondary Outcome Measures

Efficacy: VAS

Percentage VAS pain score change from baseline separately to day 3 and 7

Full Information

NCT ID

NCT01562717

First Posted

March 22, 2012

Last Updated

May 7, 2013

Sponsor

Orion Corporation, Orion Pharma

1. Study Identification

Unique Protocol Identification Number

NCT01562717

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2012

Overall Recruitment Status

Completed

Study Start Date

February 2012 (undefined)

Primary Completion Date

October 2012 (Actual)

Study Completion Date

October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Orion Corporation, Orion Pharma

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

62 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ibuprofen

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Ibuprofen

Intervention Description

3 times a day

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

3 times a day

Primary Outcome Measure Information:

Title

Efficacy: VAS

Description

VAS pain score change over time from baseline to day 7

Time Frame

Day 7

Secondary Outcome Measure Information:

Title

Efficacy: VAS

Description

Percentage VAS pain score change from baseline separately to day 3 and 7

Time Frame

Day 3 and Day 7

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Written informed consent obtained. Male and female patients, age in the range of 18-45 years (inclusive). Patients with pain related to uncomplicated ankle injuries (in case of doubt whether it is complicated an X-ray should be taken). Pain related to ankle injuries is scored as moderate or severe by the patient and the injury is less than 24 hours old. 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). Comprehension of the nature and purpose of the study and compliance with the protocol requirements. Negative urine pregnancy test (for females only). Exclusion Criteria: Known hypersensitivity to aspirin or any non-steroidal anti-inflammatory drugs (NSAID). Known history of asthma. Known history of gastric or peptic ulcer or bleeding. Known history of malignancy or other serious diseases. Known history of skin allergy. Known history of cardiac, renal or hepatic insufficiency. Presence of bruises or rash on the skin of ankle. Presence of skin lesions like eczema or psoriasis. Arthritis in the same joint. Alcohol use during the study period or within 48 hours before the study enrolment. Patients judged unable to use the VAS for pain reliably Locally applied NSAID to the painful region/area of study or oral use of NSAID or other analgesics 48 hours before the study enrolment. Other pain killers than rescue medication to be taken during the study. Recurrent sprain at the same joint during the last 6 months. Anticoagulant therapy. Physiotherapy during study period. Open wounds, infected skin or fracture. 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. Pregnant or lactating females. Participation in a drug or device study within 90 days before the study enrolment.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Juha-Pekka Kaukonen, MD

Organizational Affiliation

Terveystalo Lahti

Official's Role

Principal Investigator

Facility Information:

Facility Name

Terveystalo Lahti

City

Lahti

Country

Finland

12. IPD Sharing Statement

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Efficacy and Safety of Ibuprofen in Patients With Ankle Injuries

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