OsteoarthritisPhase 3NCT01461369

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine whether Diclofenac [Test] Capsules are safe and effective for the treatment of osteoarthritis pain of the hip or knee. 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?: Yes, some participants may receive a placebo
How many people: 305 participants
Where: 40 sitesUnited States
Study dates: Oct 2011to Oct 2012
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

Primary diagnosis of Functional Class I-III OA of the hip or knee with documented osteoarthritis flare at baseline
Chronic user of nonsteroidal anti-inflammatory drugs (NSAIDs) and/or acetaminophen for OA pain
Discontinued all analgesic therapy at Screening
For women of child-bearing potential: a woman who is not pregnant and not nursing, and who is practicing an acceptable method of birth control

Who cannot join

History of allergic reaction or clinically significant intolerance to acetaminophen, aspirin, or any NSAIDS, including diclofenac
Requires continuous use of opioid or opioid combination products to control OA pain of the knee or hip
Clinically significant unstable cardiac, respiratory, neurological, immunological, hematological, or renal disease
Significant difficulties swallowing capsules or unable to tolerate oral medication
Previous participation in another clinical study of Diclofenac Capsules or received any investigational drug or device or investigational therapy within 30 days before Screening.

Trial locations and contacts

40 sites in 1 country.

City, postcode or hospital

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

Other trials in United States

About this study

Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose, Parallel-Group, Efficacy and Safety Study of Diclofenac [Test] Capsules in Subjects With Osteoarthritis of the Knee or Hip

The purpose of this study is to determine whether Diclofenac [Test] Capsules are safe and effective for the treatment of osteoarthritis pain of the hip or knee.

Conditions: Osteoarthritis
Being tested: Diclofenac, Placebo
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 Capsules
DiclofenacDrug
35 mg tid Capsules
PlaceboDrug
Capsules

Study groups in NCT01461369
Study group	Role	What they receive
Diclofenac Capsules 35 mg bid	Experimental	Not described Receives: Drug: Diclofenac
Diclofenac Capsules 35 mg tid	Experimental	Not described Receives: Drug: Diclofenac
Placebo Capsule	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline to Week 12 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score.
The pain in subjects with osteoarthritis was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the average of the visual analogue scale (VAS) scores from 5 pain subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their pain level over the last 24 hours, with 0 mm representing "No Pain" and 100 mm representing "Extreme Pain".
The WOMAC pain subscale score difference is calculated as the WOMAC pain subscale score assessed at Week 12 minus the WOMAC pain subscale score assessed at baseline.
Measured: Baseline to Week 12/Early Termination

Secondary outcomes (5)

Change From Baseline to Week 2 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score.
The pain in subjects with osteoarthritis was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the average of the visual analogue scale (VAS) scores from 5 pain subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their pain level over the last 24 hours, with 0 mm representing "No Pain" and 100 mm representing "Extreme Pain".
The WOMAC pain subscale score difference was calculated as the WOMAC pain subscale score assessed at Week 2 minus the WOMAC pain subscale score assessed at baseline.
Measured: Baseline to Week 2
Change From Baseline to Week 6 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score.
The pain in subjects with osteoarthritis was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the average of the visual analogue scale (VAS) scores from 5 pain subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their pain level over the last 24 hours, with 0 mm representing "No Pain" and 100 mm representing "Extreme Pain".
The WOMAC pain subscale score difference was calculated as the WOMAC pain subscale score assessed at Week 6 minus the WOMAC pain subscale score assessed at baseline.
Measured: Baseline to Week 6
Change From Baseline to the Average of Weeks 2, 6, and 12 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score.
The pain in subjects with osteoarthritis was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the average of the visual analogue scale (VAS) scores from 5 pain subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their pain level over the last 24 hours, with 0 mm representing "No Pain" and 100 mm representing "Extreme Pain".
The WOMAC pain subscale score difference was calculated as the WOMAC pain subscale score assessed at Weeks 2, 6, and 12 minus the average of the WOMAC pain subscale score assessed at baseline.
Measured: Baseline to Week 12/Early Termination
Change From Baseline to the Average of Weeks 2, 6, and 12 After Trial Entry in Osteoarthritis Pain, Stiffness, and Function Measured Using the Total (Composite) Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score.
Pain, stiffness, and function in subjects with osteoarthritis were measured using the Western Ontario and McMaster Universities (WOMAC) Index, which is a 24-item questionnaire. The total (composite) WOMAC score is calculated as the average of the mean visual analogue scale (VAS) scores from the questions in the pain, stiffness, and function subscales. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their response to each of the questions, with 0 mm representing "No Pain, Stiffness, or Difficulty" and 100 mm representing "Extreme Pain, Stiffness, and Difficulty".
The total (composite) WOMAC score difference was calculated as the total (composite) WOMAC score assessed at Weeks 2, 6, and 12 minus the total (composite) WOMAC score assessed at baseline.
Measured: Baseline to Week 12/Early Termination
Change From Baseline to the Average of Weeks 2, 6, and 12 After Trial Entry in Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale.
The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing "No Pain" and 100 mm representing "Worst Pain Imaginable".
The VAS pain intensity difference is calculated as the average of the VAS pain intensity scores at Weeks 2, 6, and 12 minus the VAS pain intensity at baseline.
Measured: Baseline to Week 12/Early Termination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2011Oct 2012

First posted28 Oct 2011 (estimated)
Study startOct 2011
Primary completionMar 2012
Study completionOct 2012

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: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 305 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01461369
Sponsor's protocol ID: DIC3-08-05
Status last verified: Apr 2014
First submitted: 26 Oct 2011
Last updated: 26 May 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Gibofsky A, Hochberg MC, Jaros MJ, Young CL. Efficacy and safety of low-dose submicron diclofenac for the treatment of osteoarthritis pain: a 12 week, phase 3 study. Curr Med Res Opin. 2014 Sep;30(9):1883-93. doi: 10.1185/03007995.2014.946123. Epub 2014 Aug 6.
PubMed 25050589

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Osteoarthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 26 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose, Parallel-Group, Efficacy and Safety Study of Diclofenac [Test] Capsules in Subjects With Osteoarthritis of the Knee or Hip
ClinicalTrials.gov ID: NCT01461369
Acronym / sponsor ID: DIC3-08-05
Conditions: Osteoarthritis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 305 participants (actual)
Lead sponsor: Iroko Pharmaceuticals, LLCIndustry (pharma, biotech, devices)
Study start: Oct 2011
Primary completion: Mar 2012 (actual)
Study completion: Oct 2012 (actual)
First posted: 28 Oct 2011 (estimated)
Results: Posted 26 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 determine whether Diclofenac [Test] Capsules are safe and effective for the treatment of osteoarthritis pain of the hip or knee.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Diclofenac Capsules 35 mg bid	Experimental	Drug: Diclofenac
Diclofenac Capsules 35 mg tid	Experimental	Drug: Diclofenac
Placebo Capsule	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Primary diagnosis of Functional Class I-III OA of the hip or knee with documented osteoarthritis flare at baseline
Chronic user of nonsteroidal anti-inflammatory drugs (NSAIDs) and/or acetaminophen for OA pain
Discontinued all analgesic therapy at Screening
For women of child-bearing potential: a woman who is not pregnant and not nursing, and who is practicing an acceptable method of birth control

Key exclusion criteria (5 listed)

History of allergic reaction or clinically significant intolerance to acetaminophen, aspirin, or any NSAIDS, including diclofenac
Requires continuous use of opioid or opioid combination products to control OA pain of the knee or hip
Clinically significant unstable cardiac, respiratory, neurological, immunological, hematological, or renal disease
Significant difficulties swallowing capsules or unable to tolerate oral medication
Previous participation in another clinical study of Diclofenac Capsules or received any investigational drug or device or investigational therapy within 30 days before Screening.

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 Capsules	Drug	Diclofenac Capsules 35 mg bid
Diclofenac35 mg tid Capsules	Drug	Diclofenac Capsules 35 mg tid
PlaceboCapsules	Drug	Placebo Capsule

Primary outcome

Change From Baseline to Week 12 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score.
Time frame: Baseline to Week 12/Early Termination
The pain in subjects with osteoarthritis was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the average of the visual analogue scale (VAS) scores from 5 pain subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their pain level over the last 24 hours, with 0 mm representing "No Pain" and 100 mm representing "Extreme Pain". The WOMAC pain subscale score difference is calculated as the WOMAC pain subscale score assessed at Week 12 minus the WOMAC pain subscale score assessed at baseline.

5 secondary outcomes

Change From Baseline to Week 2 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score.
Time frame: Baseline to Week 2
Change From Baseline to Week 6 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score.
Time frame: Baseline to Week 6
Change From Baseline to the Average of Weeks 2, 6, and 12 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score.
Time frame: Baseline to Week 12/Early Termination
Change From Baseline to the Average of Weeks 2, 6, and 12 After Trial Entry in Osteoarthritis Pain, Stiffness, and Function Measured Using the Total (Composite) Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score.
Time frame: Baseline to Week 12/Early Termination
Change From Baseline to the Average of Weeks 2, 6, and 12 After Trial Entry in Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale.
Time frame: Baseline to Week 12/Early Termination

Results and safety

Results posted to the registry on 26 May 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Diclofenac 35 mg Two Times Daily	104	91
Diclofenac 35 mg Three Times Daily	98	81
Placebo	103	86

Primary outcome: Change From Baseline to Week 12 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score.

Time frame: Baseline to Week 12/Early Termination. Least squares mean (Standard Error). Unit: mm

Measure	Diclofenac 35 mg Two Times Daily n = 102	Diclofenac 35 mg Three Times Daily n = 96	Placebo n = 96
Value	-39.04 (2.905)	-44.14 (3.070)	-32.46 (2.937)

Diclofenac 35 mg Three Times Daily vs Placebo: Difference in Least Squares Mean: -11.68 (95% CI -19.17 to -4.19), p = 0.0024, Mixed Models Analysis
Diclofenac 35 mg Two Times Daily vs Placebo: Difference in Least Squares Mean: -6.58 (95% CI -13.94 to 0.78), p = 0.0795, Mixed Models Analysis

Population analysed: Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Diclofenac 35 mg Two Times Daily	3 of 104 (2.9%)	11 of 104 (10.6%)	Not reported
Diclofenac 35 mg Three Times Daily	4 of 98 (4.1%)	21 of 98 (21.4%)	Not reported
Placebo	2 of 103 (1.9%)	13 of 103 (12.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25050589Gibofsky A, Hochberg MC, Jaros MJ, Young CL. Efficacy and safety of low-dose submicron diclofenac for the treatment of osteoarthritis pain: a 12 week, phase 3 study. Curr Med Res Opin. 2014 Sep;30(9):1883-93. doi: 10.1185/03007995.2014.946123. Epub 2014 Aug 6.

Related trials for Osteoarthritis

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Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
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Effect of Anti-inflammatory Diet in Osteoarthritis
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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 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 5 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 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. 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?

Yes. Results are posted in the registry (first posted 26 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?

Change From Baseline to Week 12 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score. (time frame: Baseline to Week 12/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 NCT01461369, 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 26 May 2014.