OsteoarthritisPhase 3NCT01510912
Open-Label Study of Diclofenac Capsules to Treat Osteoarthritis Pain
A Phase 3 study testing Diclofenac in people with Osteoarthritis, run by Iroko Pharmaceuticals, LLC at 40 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety of Diclofenac [Test] Capsules for the treatment of osteoarthritis pain of the knee or hip. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Diclofenac
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 602 participants
- Where
- 40 sitesUnited States
- Study dates
- Jan 2012to Mar 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≥ [greater than or equal to] 40 years of age
- If a participant in the previous DIC3-08-05 study, completed the study and did not discontinue for lack of efficacy or safety
- Has a diagnosis of OA of the hip or knee with ongoing knee and/or articular hip pain
- Is a current chronic user of nonsteroidal anti-inflammatory drugs (NSAIDs) and/or acetaminophen for his/her OA pain and is anticipated to benefit from continuous treatment with therapeutic doses of NSAIDs. A current chronic user is defined as a subject who has used these treatments for ≥ [greater than or equal to] 20 days of the last 30 days before screening
Who cannot join
- Has a known history of allergic reaction or clinically significant intolerance to acetaminophen, aspirin, or any nonsteroid anti-inflammatory drugs (NSAIDs), including diclofenac
- Requires chronic use of opioid or opioid combination products to control OA pain of the knee or hip
- Has any clinically significant unstable cardiac, respiratory, neurological, immunological, hematological, or renal disease
- Has significant difficulties swallowing capsules or is unable to tolerate oral medication
Trial locations and contacts
40 sites in 1 country.
40 sites in 1 country
United States40 sites
Acri-Phase I, LLC
Anaheim, California, 92801
Radiant Research, Inc
Anderson, South Carolina, 29621
Clinical Study Center of Asheville, LLC
Asheville, North Carolina, 28803
Pinnacle Trials, Inc
Atlanta, Georgia, 30329
Premier Research Group - Austin
Austin, Texas, 78705
Quest Research Institute
Bingham Farms, Michigan, 48025
Med Center
Carmichael, California, 95608
Charlottesville Medical Research Center, LLC
Charlottesville, Virginia, 22911
Sterling Research Group, Ltd
Cincinnati, Ohio, 45219
Community Research
Cincinnati, Ohio, 45227
Community Research
Cincinnati, Ohio, 45245
Sterling Research Group, Ltd
Cincinnati, Ohio, 45246
Expresscare Clinical Research
Colorado Springs, Colorado, 80909
Radiant Research, Inc
Columbus, Ohio, 43212
Community Research
Crestview Hills, Kentucky, 41017
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Healthcare Research
Florissant, Missouri, 63031
Triad Clinical Research
Greensboro, North Carolina, 27408
Clinical Investigation Specialists, Inc
Gurnee, Illinois, 60031
Drug Trials America
Hartsdale, New York, 10530
Peters Medical Research
High Point, North Carolina, 27262
Westside Center for Clinical Research
Jacksonville, Florida, 32205
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
Office of Matthew Barton, MD
Las Vegas, Nevada, 89106
Lynn Institute of the Ozarks
Little Rock, Arkansas, 72205
Drug Studies America
Marietta, Georgia, 30060
Well Pharma Medical Research, Corporation
Miami, Florida, 33143
Heartland Research Associates, LLC
Newton, Kansas, 67114
Heartland Clinical Research, Inc
Omaha, Nebraska, 68134
Meridian Clinical Research
Omaha, Nebraska, 68134
Peninsula Research, Inc
Ormond Beach, Florida, 32174
Premier Research Group - Phoenix
Phoenix, Arizona, 85027
Clinical Investigations of Texas, LLC
Plano, Texas, 75075
Clinical Trials Technology Inc
Prairie Village, Kansas, 66206
Hypothetest, LLC
Roanoke, Virginia, 24018
Quality Research Inc
San Antonio, Texas, 78209
Progressive Clinical Research
San Antonio, Texas, 78229
Sundance Clinical Research, LLC
St Louis, Missouri, 63141
Professional Research Network of Kansas, LLC
Wichita, Kansas, 67203
Alliance Clinical Research
Winter Park, Florida, 32792
About this study
Official title: A Multicenter, Open-Label, Safety Study of Diclofenac [Test] Capsules in Subjects With Osteoarthritis of the Knee or Hip
The purpose of this study is to evaluate the safety of Diclofenac [Test] Capsules for the treatment of osteoarthritis pain of the knee or hip.
- Conditions
- Osteoarthritis
- Being tested
- Diclofenac
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiclofenacDrug
35 mg bid or tid Capsules
| Study group | Role | What they receive |
|---|---|---|
| Diclofenac Capsules 35 mg bid or tid | Experimental | Not described Receives: Drug: Diclofenac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of Diclofenac 35 mg Capsules as Assessed by the Incidence of Adverse Events From Baseline to Week 52 or Early Termination
The safety of Diclofenac 35 mg capsules was assessed by the number of subjects with treatment-emergent adverse events (TEAEs), severe TEAEs, and serious adverse events.
Measured: Baseline to Week 52/Early Termination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 602 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iroko Pharmaceuticals, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John M Agaiby, MD, Principal investigator, Clinical Investigation Specialists, IncEddie Armas, MD, Principal investigator, Well Pharma Medical Medical Research, CorporationMatthew Barton, MD, Principal investigator, Office of Matthew Barton, MDDavid Bouda, MD, Principal investigator, Heartland Clinical ResearchVenkata Challa, MD, Principal investigator, Peters Medical ResearchJohn Champlin, MD, Principal investigator, Med CenterFrancisco Chevres, MD, Principal investigator, Pinnacle Trials, IncMelanie Christina, MD, Principal investigator, Clinical Investigations of Texas, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01510912
- Sponsor's protocol ID
- DIC3-08-06
- Status last verified
- Apr 2014
- First submitted
- 12 Jan 2012
- Last updated
- 9 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Altman RD, Strand V, Hochberg MC, Gibofsky A, Markenson JA, Hopkins WE, Cryer B, Kivitz A, Nezzer J, Imasogie O, Young CL. Low-dose SoluMatrix diclofenac in the treatment of osteoarthritis: A 1-year, open-label, Phase III safety study. Postgrad Med. 2015 Jun;127(5):517-28. doi: 10.1080/00325481.2015.1040716. Epub 2015 Apr 27.
PubMed 25913498
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label, Safety Study of Diclofenac [Test] Capsules in Subjects With Osteoarthritis of the Knee or Hip
- ClinicalTrials.gov ID
- NCT01510912
- Acronym / sponsor ID
- DIC3-08-06
- Conditions
- Osteoarthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 602 participants (actual)
- Lead sponsor
- Iroko Pharmaceuticals, LLCIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 18 Jan 2012 (estimated)
- Results
- Posted 9 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety of Diclofenac [Test] Capsules for the treatment of osteoarthritis pain of the knee or hip.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diclofenac Capsules 35 mg bid or tid | Experimental | Drug: Diclofenac |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female ≥ [greater than or equal to] 40 years of age
- If a participant in the previous DIC3-08-05 study, completed the study and did not discontinue for lack of efficacy or safety
- Has a diagnosis of OA of the hip or knee with ongoing knee and/or articular hip pain
- Is a current chronic user of nonsteroidal anti-inflammatory drugs (NSAIDs) and/or acetaminophen for his/her OA pain and is anticipated to benefit from continuous treatment with therapeutic doses of NSAIDs. A current chronic user is defined as a subject who has used these treatments for ≥ [greater than or equal to] 20 days of the last 30 days before screening
Key exclusion criteria (4 listed)
- Has a known history of allergic reaction or clinically significant intolerance to acetaminophen, aspirin, or any nonsteroid anti-inflammatory drugs (NSAIDs), including diclofenac
- Requires chronic use of opioid or opioid combination products to control OA pain of the knee or hip
- Has any clinically significant unstable cardiac, respiratory, neurological, immunological, hematological, or renal disease
- Has significant difficulties swallowing capsules or is unable to tolerate oral medication
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 |
|---|---|---|
| Diclofenac35 mg bid or tid Capsules | Drug | Diclofenac Capsules 35 mg bid or tid |
Primary outcome
Safety of Diclofenac 35 mg Capsules as Assessed by the Incidence of Adverse Events From Baseline to Week 52 or Early Termination
Time frame: Baseline to Week 52/Early Termination
The safety of Diclofenac 35 mg capsules was assessed by the number of subjects with treatment-emergent adverse events (TEAEs), severe TEAEs, and serious adverse events.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25913498Altman RD, Strand V, Hochberg MC, Gibofsky A, Markenson JA, Hopkins WE, Cryer B, Kivitz A, Nezzer J, Imasogie O, Young CL. Low-dose SoluMatrix diclofenac in the treatment of osteoarthritis: A 1-year, open-label, Phase III safety study. Postgrad Med. 2015 Jun;127(5):517-28. doi: 10.1080/00325481.2015.1040716. Epub 2015 Apr 27.
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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.
John M Agaiby, MD principal investigator
Clinical Investigation Specialists, Inc
Eddie Armas, MD principal investigator
Well Pharma Medical Medical Research, Corporation
Matthew Barton, MD principal investigator
Office of Matthew Barton, MD
40 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Diclofenac in people with Osteoarthritis, run by Iroko Pharmaceuticals, LLC at 40 sites in United States.
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 4 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 9 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in United States. 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 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?
Yes. Results are posted in the registry (first posted 9 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Safety of Diclofenac 35 mg Capsules as Assessed by the Incidence of Adverse Events From Baseline to Week 52 or Early Termination (time frame: Baseline to Week 52/Early Termination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01510912, which also lists 1 linked publication.
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 9 May 2014.