Trial Outcomes & Findings for Study of Diclofenac Capsules to Treat Osteoarthritis Pain (NCT NCT01461369)
NCT ID: NCT01461369
Last Updated: 2014-05-26
Results Overview
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.
COMPLETED
PHASE3
305 participants
Baseline to Week 12/Early Termination
2014-05-26
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|---|---|
|
Overall Study
STARTED
|
104
|
98
|
103
|
|
Overall Study
COMPLETED
|
91
|
81
|
86
|
|
Overall Study
NOT COMPLETED
|
13
|
17
|
17
|
Reasons for withdrawal
| Measure |
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
|
|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
2
|
0
|
6
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
3
|
|
Overall Study
Adverse Event
|
9
|
12
|
4
|
|
Overall Study
Protocol Violation
|
1
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
2
|
Baseline Characteristics
Study of Diclofenac Capsules to Treat Osteoarthritis Pain
Baseline characteristics by cohort
| Measure |
Diclofenac 35 mg Two Times Daily
n=104 Participants
Diclofenac (two times daily): Capsules
|
Diclofenac 35 mg Three Times Daily
n=98 Participants
Diclofenac (three times daily): Capsules
|
Placebo
n=103 Participants
Placebo: Capsule
|
Total
n=305 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
61.4 years
STANDARD_DEVIATION 8.33 • n=5 Participants
|
61.7 years
STANDARD_DEVIATION 9.90 • n=7 Participants
|
61.8 years
STANDARD_DEVIATION 8.42 • n=5 Participants
|
61.6 years
STANDARD_DEVIATION 8.87 • n=4 Participants
|
|
Sex: Female, Male
Female
|
64 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
203 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
102 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
97 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
288 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
23 participants
n=5 Participants
|
14 participants
n=7 Participants
|
20 participants
n=5 Participants
|
57 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White or Caucasian
|
80 participants
n=5 Participants
|
83 participants
n=7 Participants
|
82 participants
n=5 Participants
|
245 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Weight
|
88.16 kg
STANDARD_DEVIATION 17.037 • n=5 Participants
|
89.35 kg
STANDARD_DEVIATION 16.552 • n=7 Participants
|
89.44 kg
STANDARD_DEVIATION 17.991 • n=5 Participants
|
88.97 kg
STANDARD_DEVIATION 17.167 • n=4 Participants
|
|
Height
|
169.91 cm
STANDARD_DEVIATION 10.561 • n=5 Participants
|
167.60 cm
STANDARD_DEVIATION 9.794 • n=7 Participants
|
168.70 cm
STANDARD_DEVIATION 9.245 • n=5 Participants
|
168.76 cm
STANDARD_DEVIATION 9.898 • n=4 Participants
|
|
Body Mass Index
|
30.6 kg/m^2
STANDARD_DEVIATION 5.18 • n=5 Participants
|
31.8 kg/m^2
STANDARD_DEVIATION 5.09 • n=7 Participants
|
31.3 kg/m^2
STANDARD_DEVIATION 5.18 • n=5 Participants
|
31.2 kg/m^2
STANDARD_DEVIATION 5.16 • n=4 Participants
|
|
Baseline Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score
|
73.42 mm
STANDARD_DEVIATION 15.22 • n=5 Participants
|
76.18 mm
STANDARD_DEVIATION 14.15 • n=7 Participants
|
75.27 mm
STANDARD_DEVIATION 17.27 • n=5 Participants
|
74.93 mm
STANDARD_DEVIATION 15.61 • n=4 Participants
|
|
Baseline Total (Composite) Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Sc
|
70.26 mm
STANDARD_DEVIATION 15.69 • n=5 Participants
|
72.83 mm
STANDARD_DEVIATION 15.87 • n=7 Participants
|
71.60 mm
STANDARD_DEVIATION 17.24 • n=5 Participants
|
71.54 mm
STANDARD_DEVIATION 16.27 • n=4 Participants
|
|
Baseline Pain Intensity Visual Analogue Scale Score
|
69.6 mm
STANDARD_DEVIATION 19.99 • n=5 Participants
|
71.8 mm
STANDARD_DEVIATION 19.33 • n=7 Participants
|
71.5 mm
STANDARD_DEVIATION 18.82 • n=5 Participants
|
71.0 mm
STANDARD_DEVIATION 19.35 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 12/Early TerminationPopulation: Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.
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.
Outcome measures
| Measure |
Diclofenac 35 mg Two Times Daily
n=102 Participants
Diclofenac (two times daily): Capsules
|
Diclofenac 35 mg Three Times Daily
n=96 Participants
Diclofenac (three times daily): Capsules
|
Placebo
n=96 Participants
Placebo: Capsule
|
|---|---|---|---|
|
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.
|
-39.04 mm
Standard Error 2.905
|
-44.14 mm
Standard Error 3.070
|
-32.46 mm
Standard Error 2.937
|
SECONDARY outcome
Timeframe: Baseline to Week 2Population: Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.
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.
Outcome measures
| Measure |
Diclofenac 35 mg Two Times Daily
n=100 Participants
Diclofenac (two times daily): Capsules
|
Diclofenac 35 mg Three Times Daily
n=94 Participants
Diclofenac (three times daily): Capsules
|
Placebo
n=92 Participants
Placebo: Capsule
|
|---|---|---|---|
|
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.
|
-31.40 mm
Standard Error 2.742
|
-37.42 mm
Standard Error 2.907
|
-21.60 mm
Standard Error 2.787
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.
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.
Outcome measures
| Measure |
Diclofenac 35 mg Two Times Daily
n=91 Participants
Diclofenac (two times daily): Capsules
|
Diclofenac 35 mg Three Times Daily
n=86 Participants
Diclofenac (three times daily): Capsules
|
Placebo
n=87 Participants
Placebo: Capsule
|
|---|---|---|---|
|
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.
|
-36.64 mm
Standard Error 2.889
|
-43.51 mm
Standard Error 3.051
|
-31.08 mm
Standard Error 2.922
|
SECONDARY outcome
Timeframe: Baseline to Week 12/Early TerminationPopulation: Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.
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.
Outcome measures
| Measure |
Diclofenac 35 mg Two Times Daily
n=104 Participants
Diclofenac (two times daily): Capsules
|
Diclofenac 35 mg Three Times Daily
n=98 Participants
Diclofenac (three times daily): Capsules
|
Placebo
n=100 Participants
Placebo: Capsule
|
|---|---|---|---|
|
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.
|
-35.62 mm
Standard Error 2.633
|
-41.38 mm
Standard Error 2.796
|
-28.14 mm
Standard Error 2.647
|
SECONDARY outcome
Timeframe: Baseline to Week 12/Early TerminationPopulation: Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the times specified.
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.
Outcome measures
| Measure |
Diclofenac 35 mg Two Times Daily
n=100 Participants
Diclofenac (two times daily): Capsules
|
Diclofenac 35 mg Three Times Daily
n=94 Participants
Diclofenac (three times daily): Capsules
|
Placebo
n=97 Participants
Placebo: Capsule
|
|---|---|---|---|
|
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.
|
-30.25 mm
Standard Error 2.632
|
-35.86 mm
Standard Error 2.798
|
-23.22 mm
Standard Error 2.656
|
SECONDARY outcome
Timeframe: Baseline to Week 12/Early TerminationPopulation: Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the times specified.
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.
Outcome measures
| Measure |
Diclofenac 35 mg Two Times Daily
n=104 Participants
Diclofenac (two times daily): Capsules
|
Diclofenac 35 mg Three Times Daily
n=98 Participants
Diclofenac (three times daily): Capsules
|
Placebo
n=100 Participants
Placebo: Capsule
|
|---|---|---|---|
|
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.
|
-36.41 mm
Standard Error 2.670
|
-41.33 mm
Standard Error 2.830
|
-30.95 mm
Standard Error 2.690
|
Adverse Events
Diclofenac 35 mg Two Times Daily
Diclofenac 35 mg Three Times Daily
Placebo
Serious adverse events
| Measure |
Diclofenac 35 mg Two Times Daily
n=104 participants at risk
Diclofenac Test (two times daily): Capsules
|
Diclofenac 35 mg Three Times Daily
n=98 participants at risk
Diclofenac Test (three times daily): Capsules
|
Placebo
n=103 participants at risk
Placebo: Capsule
|
|---|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/104
|
1.0%
1/98
|
0.00%
0/103
|
|
Infections and infestations
Appendicitis
|
0.96%
1/104
|
0.00%
0/98
|
0.00%
0/103
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/104
|
1.0%
1/98
|
0.00%
0/103
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.96%
1/104
|
0.00%
0/98
|
0.00%
0/103
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/104
|
1.0%
1/98
|
0.00%
0/103
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer metastatic
|
0.96%
1/104
|
0.00%
0/98
|
0.00%
0/103
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/104
|
1.0%
1/98
|
0.00%
0/103
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.96%
1/104
|
0.00%
0/98
|
0.00%
0/103
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.96%
1/104
|
0.00%
0/98
|
0.00%
0/103
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/104
|
1.0%
1/98
|
0.00%
0/103
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/104
|
1.0%
1/98
|
0.00%
0/103
|
|
Nervous system disorders
Hemiplegic migraine
|
0.00%
0/104
|
0.00%
0/98
|
0.97%
1/103
|
|
Nervous system disorders
Syncope
|
0.00%
0/104
|
0.00%
0/98
|
0.97%
1/103
|
Other adverse events
| Measure |
Diclofenac 35 mg Two Times Daily
n=104 participants at risk
Diclofenac Test (two times daily): Capsules
|
Diclofenac 35 mg Three Times Daily
n=98 participants at risk
Diclofenac Test (three times daily): Capsules
|
Placebo
n=103 participants at risk
Placebo: Capsule
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
4.8%
5/104
|
7.1%
7/98
|
2.9%
3/103
|
|
Nervous system disorders
Headache
|
1.9%
2/104
|
6.1%
6/98
|
2.9%
3/103
|
|
Gastrointestinal disorders
Nausea
|
4.8%
5/104
|
9.2%
9/98
|
1.9%
2/103
|
|
Infections and infestations
Upper respiratory tract infection
|
2.9%
3/104
|
3.1%
3/98
|
5.8%
6/103
|
Additional Information
Daniel Solorio, Executive Director of Clinical Operations
Iroko Pharmaceuticals, LLC
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place