Efficacy and Safety of Ibuprofen in Patients With Ankle Injuries
This study has been completed.
Sponsor:
Orion Corporation, Orion Pharma
Information provided by (Responsible Party):
Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier:
NCT01563289
First received: March 22, 2012
Last updated: May 7, 2013
Last verified: September 2012
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Purpose
The objective of the study is to evaluate the efficacy and safety of Ibuprofen in patients with ankle injuries.
| Condition | Intervention | Phase |
|---|---|---|
|
Pain |
Drug: Ibuprofen Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Orion Corporation, Orion Pharma:
Primary Outcome Measures:
- Efficacy: visual analog scale (VAS) [ Time Frame: Day 7 ] [ Designated as safety issue: No ]VAS pain score change over time from baseline to day 7
Secondary Outcome Measures:
- Efficacy: VAS [ Time Frame: Day 3 and Day 7 ] [ Designated as safety issue: No ]Percentage VAS pain score change from baseline separately to day 3 and 7
| Enrollment: | 62 |
| Study Start Date: | February 2012 |
| Study Completion Date: | July 2012 |
| Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: placebo |
Drug: Placebo
3 times a day
|
| Experimental: Ibuprofen |
Drug: Ibuprofen
3 times a day
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01563289
Please refer to this study by its ClinicalTrials.gov identifier: NCT01563289
Locations
| Finland | |
| Terveystalo Lahti | |
| Lahti, Finland | |
Sponsors and Collaborators
Orion Corporation, Orion Pharma
Investigators
| Principal Investigator: | Juha-Pekka Kaukonen, MD | Terveystalo Lahti |
More Information
| Responsible Party: | Orion Corporation, Orion Pharma |
| ClinicalTrials.gov Identifier: | NCT01563289 History of Changes |
| Other Study ID Numbers: | 0028021 2011-004496-37 |
| Study First Received: | March 22, 2012 |
| Last Updated: | May 7, 2013 |
| Health Authority: | Finland: Finnish Medicines Agency Lithuania: State Medicine Control Agency - Ministry of Health Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products |
Additional relevant MeSH terms:
|
Ankle Injuries Leg Injuries Wounds and Injuries Ibuprofen Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on September 23, 2016