PainPhase 3NCT01563289
Efficacy and Safety of Ibuprofen in Patients With Ankle Injuries
A Phase 3 study testing Ibuprofen in people with Pain, run by Orion Corporation, Orion Pharma at 1 site in Finland.
Trial summary
The objective of the study is to evaluate the efficacy and safety of Ibuprofen in patients with ankle injuries. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Pain
- What is being tested?
- Ibuprofen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteFinland
- Study dates
- Feb 2012to Jul 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
The objective of the study is to evaluate the efficacy and safety of Ibuprofen in patients with ankle injuries.
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbuprofenDrug
3 times a day
PlaceboDrug
3 times a day
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Ibuprofen | Experimental | Not described Receives: Drug: Ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: visual analog scale (VAS)
VAS pain score change over time from baseline to day 7
Measured: Day 7
Secondary outcomes (1)
Efficacy: VAS
Percentage VAS pain score change from baseline separately to day 3 and 7
Measured: Day 3 and Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orion Corporation, Orion Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Juha-Pekka Kaukonen, MD, Principal investigator, Terveystalo Lahti
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01563289
- Sponsor's protocol ID
- 0028021
- Other IDs
- 2011-004496-37
- Status last verified
- Sep 2012
- First submitted
- 22 Mar 2012
- Last updated
- 8 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01563289
- Acronym / sponsor ID
- 0028021
- Conditions
- Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Orion Corporation, Orion PharmaIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 26 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: Placebo |
| Ibuprofen | Experimental | Drug: Ibuprofen |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ibuprofen3 times a day | Drug | Ibuprofen |
| Placebo3 times a day | Drug | placebo |
Primary outcome
Efficacy: visual analog scale (VAS)
Time frame: Day 7
VAS pain score change over time from baseline to day 7
1 secondary outcome
Efficacy: VAS
Time frame: Day 3 and Day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juha-Pekka Kaukonen, MD principal investigator
Terveystalo Lahti
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ibuprofen in people with Pain, run by Orion Corporation, Orion Pharma at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy: visual analog scale (VAS) (time frame: Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2013.