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Study of Diclofenac Capsules to Treat Osteoarthritis Pain

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ClinicalTrials.gov Identifier: NCT01461369
Recruitment Status : Completed
First Posted : October 28, 2011
Results First Posted : May 26, 2014
Last Update Posted : May 26, 2014
Sponsor:
Information provided by (Responsible Party):
Iroko Pharmaceuticals, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Osteoarthritis
Interventions Drug: Diclofenac
Drug: Placebo
Enrollment 305
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Diclofenac 35 mg Two Times Daily Diclofenac 35 mg Three Times Daily Placebo
Hide Arm/Group Description Diclofenac (two times daily): Capsules Diclofenac (three times daily): Capsules Placebo: Capsule
Period Title: Overall Study
Started 104 98 103
Completed 91 81 86
Not Completed 13 17 17
Reason Not Completed
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
Arm/Group Title Diclofenac 35 mg Two Times Daily Diclofenac 35 mg Three Times Daily Placebo Total
Hide Arm/Group Description Diclofenac (two times daily): Capsules Diclofenac (three times daily): Capsules Placebo: Capsule Total of all reporting groups
Overall Number of Baseline Participants 104 98 103 305
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 104 participants 98 participants 103 participants 305 participants
61.4  (8.33) 61.7  (9.90) 61.8  (8.42) 61.6  (8.87)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 104 participants 98 participants 103 participants 305 participants
Female
64
  61.5%
68
  69.4%
71
  68.9%
203
  66.6%
Male
40
  38.5%
30
  30.6%
32
  31.1%
102
  33.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 104 participants 98 participants 103 participants 305 participants
Hispanic or Latino
7
   6.7%
2
   2.0%
8
   7.8%
17
   5.6%
Not Hispanic or Latino
97
  93.3%
96
  98.0%
95
  92.2%
288
  94.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 104 participants 98 participants 103 participants 305 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
[1]
Measure Description: Subjects were allowed to select more than one race; therefore, some subjects are counted multiple times.
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 104 participants 98 participants 103 participants 305 participants
88.16  (17.037) 89.35  (16.552) 89.44  (17.991) 88.97  (17.167)
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 104 participants 98 participants 103 participants 305 participants
169.91  (10.561) 167.60  (9.794) 168.70  (9.245) 168.76  (9.898)
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 104 participants 98 participants 103 participants 305 participants
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   [1] 
Mean (Standard Deviation)
Unit of measure:  Mm
Number Analyzed 104 participants 98 participants 103 participants 305 participants
73.42  (15.22) 76.18  (14.15) 75.27  (17.27) 74.93  (15.61)
[1]
Measure Description: 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".
Baseline Total (Composite) Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Sc   [1] 
Mean (Standard Deviation)
Unit of measure:  Mm
Number Analyzed 104 participants 98 participants 103 participants 305 participants
70.26  (15.69) 72.83  (15.87) 71.60  (17.24) 71.54  (16.27)
[1]
Measure Description:

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.

Baseline Pain Intensity Visual Analogue Scale Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Mm
Number Analyzed 104 participants 98 participants 103 participants 305 participants
69.6  (19.99) 71.8  (19.33) 71.5  (18.82) 71.0  (19.35)
[1]
Measure Description:

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.

1.Primary Outcome
Title 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.
Hide Description

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.

Time Frame Baseline to Week 12/Early Termination
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.
Arm/Group Title Diclofenac 35 mg Two Times Daily Diclofenac 35 mg Three Times Daily Placebo
Hide Arm/Group Description:
Diclofenac (two times daily): Capsules
Diclofenac (three times daily): Capsules
Placebo: Capsule
Overall Number of Participants Analyzed 102 96 96
Least Squares Mean (Standard Error)
Unit of Measure: mm
-39.04  (2.905) -44.14  (3.070) -32.46  (2.937)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Diclofenac 35 mg Three Times Daily, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0024
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value -11.68
Confidence Interval (2-Sided) 95%
-19.17 to -4.19
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.806
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Diclofenac 35 mg Two Times Daily, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0795
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value -6.58
Confidence Interval (2-Sided) 95%
-13.94 to 0.78
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.739
Estimation Comments [Not Specified]
2.Secondary Outcome
Title 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.
Hide Description

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.

Time Frame Baseline to Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.
Arm/Group Title Diclofenac 35 mg Two Times Daily Diclofenac 35 mg Three Times Daily Placebo
Hide Arm/Group Description:
Diclofenac (two times daily): Capsules
Diclofenac (three times daily): Capsules
Placebo: Capsule
Overall Number of Participants Analyzed 100 94 92
Least Squares Mean (Standard Error)
Unit of Measure: mm
-31.40  (2.742) -37.42  (2.907) -21.60  (2.787)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Diclofenac 35 mg Three Times Daily, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value -15.82
Confidence Interval (2-Sided) 95%
-22.82 to -8.83
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.552
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Diclofenac 35 mg Two Times Daily, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0052
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value -9.80
Confidence Interval (2-Sided) 95%
-16.66 to -2.95
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.481
Estimation Comments [Not Specified]
3.Secondary Outcome
Title 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.
Hide Description

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.

Time Frame Baseline to Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.
Arm/Group Title Diclofenac 35 mg Two Times Daily Diclofenac 35 mg Three Times Daily Placebo
Hide Arm/Group Description:
Diclofenac (two times daily): Capsules
Diclofenac (three times daily): Capsules
Placebo: Capsule
Overall Number of Participants Analyzed 91 86 87
Least Squares Mean (Standard Error)
Unit of Measure: mm
-36.64  (2.889) -43.51  (3.051) -31.08  (2.922)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Diclofenac 35 mg Three Times Daily, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0011
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value -12.43
Confidence Interval (2-Sided) 95%
-19.87 to -4.99
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.776
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Diclofenac 35 mg Two Times Daily, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1349
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value -5.56
Confidence Interval (2-Sided) 95%
-12.86 to 1.74
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.707
Estimation Comments [Not Specified]
4.Secondary Outcome
Title 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.
Hide Description

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.

Time Frame Baseline to Week 12/Early Termination
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.
Arm/Group Title Diclofenac 35 mg Two Times Daily Diclofenac 35 mg Three Times Daily Placebo
Hide Arm/Group Description:
Diclofenac (two times daily): Capsules
Diclofenac (three times daily): Capsules
Placebo: Capsule
Overall Number of Participants Analyzed 104 98 100
Least Squares Mean (Standard Error)
Unit of Measure: mm
-35.62  (2.633) -41.38  (2.796) -28.14  (2.647)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Diclofenac 35 mg Three Times Daily, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value -13.24
Confidence Interval (2-Sided) 95%
-19.89 to -6.59
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.377
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Diclofenac 35 mg Two Times Daily, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0248
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value -7.48
Confidence Interval (2-Sided) 95%
-14.00 to -0.96
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.313
Estimation Comments [Not Specified]
5.Secondary Outcome
Title 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.
Hide Description

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.

Time Frame Baseline to Week 12/Early Termination
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the times specified.
Arm/Group Title Diclofenac 35 mg Two Times Daily Diclofenac 35 mg Three Times Daily Placebo
Hide Arm/Group Description:
Diclofenac (two times daily): Capsules
Diclofenac (three times daily): Capsules
Placebo: Capsule
Overall Number of Participants Analyzed 100 94 97
Least Squares Mean (Standard Error)
Unit of Measure: mm
-30.25  (2.632) -35.86  (2.798) -23.22  (2.656)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Diclofenac 35 mg Three Times Daily, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value -12.63
Confidence Interval (2-Sided) 95%
-19.32 to -5.94
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.396
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Diclofenac 35 mg Two Times Daily, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0363
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value -7.03
Confidence Interval (2-Sided) 95%
-13.60 to -0.45
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.339
Estimation Comments [Not Specified]
6.Secondary Outcome
Title 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.
Hide Description

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.

Time Frame Baseline to Week 12/Early Termination
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the times specified.
Arm/Group Title Diclofenac 35 mg Two Times Daily Diclofenac 35 mg Three Times Daily Placebo
Hide Arm/Group Description:
Diclofenac (two times daily): Capsules
Diclofenac (three times daily): Capsules
Placebo: Capsule
Overall Number of Participants Analyzed 104 98 100
Least Squares Mean (Standard Error)
Unit of Measure: mm
-36.41  (2.670) -41.33  (2.830) -30.95  (2.690)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Diclofenac 35 mg Three Times Daily, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0028
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value -10.38
Confidence Interval (2-Sided) 95%
-17.16 to -3.60
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.441
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Diclofenac 35 mg Two Times Daily, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1081
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value -5.46
Confidence Interval (2-Sided) 95%
-12.13 to 1.21
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.385
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Diclofenac 35 mg Two Times Daily Diclofenac 35 mg Three Times Daily Placebo
Hide Arm/Group Description Diclofenac Test (two times daily): Capsules Diclofenac Test (three times daily): Capsules Placebo: Capsule
All-Cause Mortality
Diclofenac 35 mg Two Times Daily Diclofenac 35 mg Three Times Daily Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Diclofenac 35 mg Two Times Daily Diclofenac 35 mg Three Times Daily Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/104 (2.88%)   4/98 (4.08%)   2/103 (1.94%) 
General disorders       
Non-cardiac chest pain  0/104 (0.00%)  1/98 (1.02%)  0/103 (0.00%) 
Infections and infestations       
Appendicitis  1/104 (0.96%)  0/98 (0.00%)  0/103 (0.00%) 
Investigations       
Alanine aminotransferase increased  0/104 (0.00%)  1/98 (1.02%)  0/103 (0.00%) 
Aspartate aminotransferase increased  0/104 (0.00%)  1/98 (1.02%)  0/103 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Hepatic cancer metastatic  1/104 (0.96%)  0/98 (0.00%)  0/103 (0.00%) 
Malignant melanoma  0/104 (0.00%)  1/98 (1.02%)  0/103 (0.00%) 
Metastases to lung  1/104 (0.96%)  0/98 (0.00%)  0/103 (0.00%) 
Metastatic neoplasm  1/104 (0.96%)  0/98 (0.00%)  0/103 (0.00%) 
Nervous system disorders       
Hemiplegic migraine  0/104 (0.00%)  0/98 (0.00%)  1/103 (0.97%) 
Syncope  0/104 (0.00%)  0/98 (0.00%)  1/103 (0.97%) 
Respiratory, thoracic and mediastinal disorders       
Chronic obstructive pulmonary disease  1/104 (0.96%)  0/98 (0.00%)  0/103 (0.00%) 
Pulmonary embolism  0/104 (0.00%)  1/98 (1.02%)  0/103 (0.00%) 
Vascular disorders       
Deep vein thrombosis  0/104 (0.00%)  1/98 (1.02%)  0/103 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Diclofenac 35 mg Two Times Daily Diclofenac 35 mg Three Times Daily Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   11/104 (10.58%)   21/98 (21.43%)   13/103 (12.62%) 
Gastrointestinal disorders       
Diarrhea  5/104 (4.81%)  7/98 (7.14%)  3/103 (2.91%) 
Nausea  5/104 (4.81%)  9/98 (9.18%)  2/103 (1.94%) 
Infections and infestations       
Upper respiratory tract infection  3/104 (2.88%)  3/98 (3.06%)  6/103 (5.83%) 
Nervous system disorders       
Headache  2/104 (1.92%)  6/98 (6.12%)  3/103 (2.91%) 
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
Layout table for Results Point of Contact information
Name/Title: Daniel Solorio, Executive Director of Clinical Operations
Organization: Iroko Pharmaceuticals, LLC
Phone: 267-546-3150
EMail: dsolorio@iroko.com
Layout table for additonal information
Responsible Party: Iroko Pharmaceuticals, LLC
ClinicalTrials.gov Identifier: NCT01461369     History of Changes
Other Study ID Numbers: DIC3-08-05
First Submitted: October 26, 2011
First Posted: October 28, 2011
Results First Submitted: March 12, 2014
Results First Posted: May 26, 2014
Last Update Posted: May 26, 2014