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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
Sponsored by
Orion Corporation, Orion Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

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:

  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.

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

First Posted
March 22, 2012
Last Updated
May 7, 2013
Sponsor
Orion Corporation, Orion Pharma
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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
No

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
No
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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