Efficacy and Safety of Ibuprofen in Patients With Ankle Injuries

NCT01562717 | Completed Phase 3

• 2 other identifiers: 00280222011-004497-28
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• Efficacy: VAS

  VAS pain score change over time from baseline to day 7

  Day 7

Secondary Outcomes (1)

• Efficacy: VAS

  Day 3 and Day 7

Study Arms (2)

Ibuprofen

EXPERIMENTAL

Drug: Ibuprofen

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Ibuprofen DRUG

3 times a day

Ibuprofen

Placebo DRUG

3 times a day

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Orion Corporation, Orion Pharma: lead

Study Sites (1)

Terveystalo Lahti

Lahti, Finland

Location

MeSH Terms

Conditions

Pain

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Juha-Pekka Kaukonen, MD

  Terveystalo Lahti

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2012
• First Posted: March 26, 2012
• Study Start: February 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: May 8, 2013

Record last verified: 2012-10

Locations

FI (1)