Study of Diclofenac Capsules to Treat Osteoarthritis Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Iroko Pharmaceuticals, LLC
ClinicalTrials.gov Identifier:
NCT01461369
First received: October 26, 2011
Last updated: April 29, 2014
Last verified: April 2014
Results First Received: March 12, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Osteoarthritis
Interventions: Drug: Diclofenac
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Diclofenac 35 mg Two Times Daily Diclofenac (two times daily): Capsules
Diclofenac 35 mg Three Times Daily Diclofenac (three times daily): Capsules
Placebo Placebo: Capsule

Participant Flow:   Overall Study
    Diclofenac 35 mg Two Times Daily     Diclofenac 35 mg Three Times Daily     Placebo  
STARTED     104     98     103  
COMPLETED     91     81     86  
NOT COMPLETED     13     17     17  
Lack of Efficacy                 2                 0                 6  
Lost to Follow-up                 0                 0                 3  
Adverse Event                 9                 12                 4  
Protocol Violation                 1                 2                 2  
Withdrawal by Subject                 1                 3                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Diclofenac 35 mg Two Times Daily Diclofenac (two times daily): Capsules
Diclofenac 35 mg Three Times Daily Diclofenac (three times daily): Capsules
Placebo Placebo: Capsule
Total Total of all reporting groups

Baseline Measures
    Diclofenac 35 mg Two Times Daily     Diclofenac 35 mg Three Times Daily     Placebo     Total  
Number of Participants  
[units: participants]
  104     98     103     305  
Age  
[units: years]
Mean ± Standard Deviation
  61.4  ± 8.33     61.7  ± 9.90     61.8  ± 8.42     61.6  ± 8.87  
Gender  
[units: participants]
       
Female     64     68     71     203  
Male     40     30     32     102  
Ethnicity (NIH/OMB)  
[units: participants]
       
Hispanic or Latino     7     2     8     17  
Not Hispanic or Latino     97     96     95     288  
Unknown or Not Reported     0     0     0     0  
Race/Ethnicity, Customized [1]
[units: participants]
       
American Indian or Alaska Native     1     0     0     1  
Asian     0     0     0     0  
Native Hawaiian or Other Pacific Islander     1     0     0     1  
Black or African American     23     14     20     57  
White or Caucasian     80     83     82     245  
Other     0     1     1     2  
Weight  
[units: kg]
Mean ± Standard Deviation
  88.16  ± 17.037     89.35  ± 16.552     89.44  ± 17.991     88.97  ± 17.167  
Height  
[units: cm]
Mean ± Standard Deviation
  169.91  ± 10.561     167.60  ± 9.794     168.70  ± 9.245     168.76  ± 9.898  
Body Mass Index  
[units: kg/m^2]
Mean ± Standard Deviation
  30.6  ± 5.18     31.8  ± 5.09     31.3  ± 5.18     31.2  ± 5.16  
Baseline Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score [2]
[units: mm]
Mean ± Standard Deviation
  73.42  ± 15.22     76.18  ± 14.15     75.27  ± 17.27     74.93  ± 15.61  
Baseline Total (Composite) Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Sc [3]
[units: mm]
Mean ± Standard Deviation
  70.26  ± 15.69     72.83  ± 15.87     71.60  ± 17.24     71.54  ± 16.27  
Baseline Pain Intensity Visual Analogue Scale Score [4]
[units: mm]
Mean ± Standard Deviation
  69.6  ± 19.99     71.8  ± 19.33     71.5  ± 18.82     71.0  ± 19.35  
[1] Subjects were allowed to select more than one race; therefore, some subjects are counted multiple times.
[2] The pain in subjects with osteoarthritis was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the mean 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 within the past 24 hours, with 0 mm representing "No Pain" and 100 mm representing "Worst Possible Pain".
[3]

The pain, stiffness, and physical function in subjects with osteoarthritis were measured at baseline using the total (composite) Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scale. The total WOMAC score is the average of the mean visual analogue scale scores, with 0 mm meaning "No Limitation" and 100 mm meaning "Extreme Limitation".

Baseline total (composite) WOMAC score was calculated for 100 subjects in the Diclofenac Test Capsules two times daily group, 94 subjects in the Diclofenac Test Capsules three times daily group, and 100 subjects in the placebo group.

[4]

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 Possible Pain".

The Baseline Pain Intensity VAS score was calculated for 100 subjects in the Diclofenac Test Capsules two times daily group, 94 subjects in the Diclofenac Test Capsules three times daily group, and 100 subjects in the placebo group.




  Outcome Measures
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1.  Primary:   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 ]

2.  Secondary:   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 ]

3.  Secondary:   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 ]

4.  Secondary:   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 ]

5.  Secondary:   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 ]

6.  Secondary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Daniel Solorio, Executive Director of Clinical Operations
Organization: Iroko Pharmaceuticals, LLC
phone: 267-546-3150
e-mail: dsolorio@iroko.com


No publications provided


Responsible Party: Iroko Pharmaceuticals, LLC
ClinicalTrials.gov Identifier: NCT01461369     History of Changes
Other Study ID Numbers: DIC3-08-05
Study First Received: October 26, 2011
Results First Received: March 12, 2014
Last Updated: April 29, 2014
Health Authority: United States: Food and Drug Administration