OsteoarthritisPhase 2NCT00219700
Ibuprofen-PC Compared With Ibuprofen in a GI Safety Trial
A Phase 2 study testing Ibuprofen-PC in people with Osteoarthritis, run by PLx Pharma.
Trial summary
To determine the safety and efficacy of 3 x 800 mg/day IBU-PC assessed by endoscopy and incidence of adverse events Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Ibuprofen-PC
- How many people
- 125 participants
- Where
- No sites listed yet
- Study dates
- Jan 2005to Nov 2005
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- moderate osteoarthritis in the hip and/or knee requiring chronic pain medication
- others per protocol
Who cannot join
- sensitivity to NSAIDs and lecithin
- hypertension
- history of GI and other specific problems
- use of medications and other criteria per the protocol
About this study
Official title: Phase II, Randomized, Blinded Study of Ibuprofen-PC and Ibuprofen in Patients With Osteoarthritis to Investigate Efficacy and Gastrointestinal Toxicity
To determine the safety and efficacy of 3 x 800 mg/day IBU-PC assessed by endoscopy and incidence of adverse events
- Conditions
- Osteoarthritis
- Being tested
- Ibuprofen-PC
- Keywords
- NSAID-PC, IBU-PC
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ibuprofen-PCDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Lanza score assessed by endoscopy at baseline and after six weeks of treatment to measure GI safety.
Secondary outcomes (1)
WOMAC and VAS scores every two weeks until end of treatment to measure efficacy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJan 2005
- Primary completionNov 2005
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 125 participants
Sponsor and investigators
- Lead sponsor
- PLx Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH), Texas Higher Education Coordinating Board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00219700
- Sponsor's protocol ID
- PL-IB-002
- Status last verified
- Nov 2008
- First submitted
- 20 Sep 2005
- Last updated
- 26 Nov 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Randomized, Blinded Study of Ibuprofen-PC and Ibuprofen in Patients With Osteoarthritis to Investigate Efficacy and Gastrointestinal Toxicity
- ClinicalTrials.gov ID
- NCT00219700
- Acronym / sponsor ID
- PL-IB-002
- Conditions
- Osteoarthritis
- Keywords
- NSAID-PC, IBU-PC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants
- Lead sponsor
- PLx PharmaIndustry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH), Texas Higher Education Coordinating Board
- Study start
- Jan 2005
- Primary completion
- Nov 2005 (actual)
- Study completion
- Nov 2005 (actual)
- First posted
- 22 Sep 2005 (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.
To determine the safety and efficacy of 3 x 800 mg/day IBU-PC assessed by endoscopy and incidence of adverse events
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- moderate osteoarthritis in the hip and/or knee requiring chronic pain medication
- others per protocol
Key exclusion criteria (4 listed)
- sensitivity to NSAIDs and lecithin
- hypertension
- history of GI and other specific problems
- use of medications and other criteria per the protocol
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 |
|---|---|---|
| Ibuprofen-PC | Drug | – |
Primary outcome
Lanza score assessed by endoscopy at baseline and after six weeks of treatment to measure GI safety.
1 secondary outcome
WOMAC and VAS scores every two weeks until end of treatment to measure efficacy.
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 26 Nov 2008.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ibuprofen-PC in people with Osteoarthritis, run by PLx Pharma.
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 2 inclusion and 4 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 26 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Lanza score assessed by endoscopy at baseline and after six weeks of treatment to measure GI safety.. 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 26 Nov 2008.