Osteoarthritis of the Hip or KneePhase 4NCT01066676
Dexibuprofen 400 mg Sachet Versus Ibuprofen 400 mg Sachet in Patients With Osteoarthritis of the Hip or Knee
A Phase 4 study testing Dexibuprofen and Ibuprofen in people with Osteoarthritis of the Hip or Knee, run by Gebro Pharma GmbH at 2 sites in Austria.
Trial summary
Medical condition under investigation: Osteoarthritis of the hip or knee Number of patients planned: 480 adult patients Main objective: To evaluate and compare the tolerability profile of Dexibuprofen Gebro 400 mg powder for oral suspension compared to Ibuprofen 400 mg in patients with painful osteoarthritis of the… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Osteoarthritis of the Hip or Knee
- What is being tested?
- Dexibuprofen and Ibuprofen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 482 participants
- Where
- 2 sitesAustria
- Study dates
- Oct 2009to Jun 2012
- Phase
- Phase 4
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male or female patients aged between 18 and 75 years
- everyday joint pain for the past three months
- global pain intensity in the involved joint (hip or knee) of "moderate" to "severe" within the last 48 h
Who cannot join
- acute inflammation or ischaemic necrosis
- paget's disease, chondrocalcinosis, ochronosis of the hip/knee joint
- slowly progressing hip/knee arthropathy in particular of tuberculosis aetiology
- hip/knee arthropathy due to diabetes mellitus
- Charcot's joint
- villous synovitis
- chondromatosis of the synovium
- patients with existing gastritis or existing ulcers or bleedings in the gastrointestinal tract or patients with history of gastrointestinal ulcers or gastrointestinal haemorrhage in the past 6 months
Trial locations and contacts
2 sites in 1 country.
Austria2 sites
Rehabzentrum für Erkrankungen des rheumat. Formenkreises
Bad Hofgastein, State of Salzburg, 5630
Rheuma Zentrum Favoriten
Vienna, 1100
About this study
Official title: Prospective, Clinical Trial to Investigate Safety, Tolerability and Efficacy of Dexibuprofen Gebro 400 mg Powder for Oral Suspension (Test) Compared to Ibuprofen 400 mg Powder for Oral Suspension (Reference) in Patients Suffering From Osteoarthritis of the Hip or Knee
Medical condition under investigation: Osteoarthritis of the hip or knee
Number of patients planned: 480 adult patients
Main objective: To evaluate and compare the tolerability profile of Dexibuprofen Gebro 400 mg powder for oral suspension compared to Ibuprofen 400 mg in patients with painful osteoarthritis of the hip or knee
Secondary objectives: To compare the overall efficacy of Dexibuprofen Gebro 400 mg powder for oral suspension compared to Ibuprofen 400 mg in patients suffering from different complaints due to painful osteoarthritis of the hip or knee
- Conditions
- Osteoarthritis of the Hip or Knee
- Being tested
- Dexibuprofen, Ibuprofen
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexibuprofenDrug
400mg powder for oral suspension, daily dose 800mg
IbuprofenDrug
400mg, powder for oral suspension, daily dose 1600mg
| Study group | Role | What they receive |
|---|---|---|
| Dexibuprofen | Experimental | Dexibuprofen 400 mg powder for oral suspension Receives: Drug: Dexibuprofen |
| Ibuprofen | Active comparator | Ibuprofen 400 mg powder for oral suspension Receives: Drug: Ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerability profile of Dexibuprofen Gebro 400 mg powder for oral suspension compared to Ibuprofen 400 mg in patients with painful osteoarthritis of the hip or knee
Measured: 14 days
Secondary outcomes (1)
Overall efficacy of Dexibuprofen Gebro 400 mg powder for oral suspension compared to Ibuprofen 400 mg in patients suffering from different complaints due to painful osteoarthritis of the hip or knee
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2010 (estimated)
- Study startOct 2009
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of the Hip or KneeStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 482 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gebro Pharma GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Reinhold Hawel, MD, Principal investigator, Rehabilitationszentrum, Bad Hofgastein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01066676
- Sponsor's protocol ID
- IV/48.4
- Status last verified
- Jul 2012
- First submitted
- 9 Feb 2010
- Last updated
- 10 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Clinical Trial to Investigate Safety, Tolerability and Efficacy of Dexibuprofen Gebro 400 mg Powder for Oral Suspension (Test) Compared to Ibuprofen 400 mg Powder for Oral Suspension (Reference) in Patients Suffering From Osteoarthritis of the Hip or Knee
- ClinicalTrials.gov ID
- NCT01066676
- Acronym / sponsor ID
- IV/48.4
- Conditions
- Osteoarthritis of the Hip or Knee
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 482 participants (actual)
- Lead sponsor
- Gebro Pharma GmbHIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 10 Feb 2010 (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.
Medical condition under investigation: Osteoarthritis of the hip or knee
Number of patients planned: 480 adult patients
Main objective: To evaluate and compare the tolerability profile of Dexibuprofen Gebro 400 mg powder for oral suspension compared to Ibuprofen 400 mg in patients with painful osteoarthritis of the hip or knee
Secondary objectives: To compare the overall efficacy of Dexibuprofen Gebro 400 mg powder for oral suspension compared to Ibuprofen 400 mg in patients suffering from different complaints due to painful osteoarthritis of the hip or knee
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexibuprofen | Experimental | Drug: DexibuprofenDexibuprofen 400 mg powder for oral suspension |
| Ibuprofen | Active comparator | Drug: IbuprofenIbuprofen 400 mg powder for oral suspension |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- male or female patients aged between 18 and 75 years
- everyday joint pain for the past three months
- global pain intensity in the involved joint (hip or knee) of "moderate" to "severe" within the last 48 h
Key exclusion criteria (8 listed)
- acute inflammation or ischaemic necrosis
- paget's disease, chondrocalcinosis, ochronosis of the hip/knee joint
- slowly progressing hip/knee arthropathy in particular of tuberculosis aetiology
- hip/knee arthropathy due to diabetes mellitus
- Charcot's joint
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 |
|---|---|---|
| Dexibuprofen400mg powder for oral suspension, daily dose 800mg | Drug | Dexibuprofen |
| Ibuprofen400mg, powder for oral suspension, daily dose 1600mg | Drug | Ibuprofen |
Primary outcome
Tolerability profile of Dexibuprofen Gebro 400 mg powder for oral suspension compared to Ibuprofen 400 mg in patients with painful osteoarthritis of the hip or knee
Time frame: 14 days
1 secondary outcome
Overall efficacy of Dexibuprofen Gebro 400 mg powder for oral suspension compared to Ibuprofen 400 mg in patients suffering from different complaints due to painful osteoarthritis of the hip or knee
Time frame: 14 days
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 10 Jul 2012.
- Related InfoLink provided by the sponsor.
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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.
Reinhold Hawel, MD principal investigator
Rehabilitationszentrum, Bad Hofgastein
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexibuprofen and Ibuprofen in people with Osteoarthritis of the Hip or Knee, run by Gebro Pharma GmbH at 2 sites in Austria.
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 3 inclusion and 8 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 10 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Tolerability profile of Dexibuprofen Gebro 400 mg powder for oral suspension compared to Ibuprofen 400 mg in patients with painful osteoarthritis of the hip or knee (time frame: 14 days). 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 10 Jul 2012.