Trial Outcomes & Findings for Open-Label Study of Diclofenac Capsules to Treat Osteoarthritis Pain (NCT NCT01510912)
NCT ID: NCT01510912
Last Updated: 2014-05-09
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
602 participants
Primary outcome timeframe
Baseline to Week 52/Early Termination
Results posted on
2014-05-09
Participant Flow
Participant milestones
| Measure |
Diclofenac 35 mg Capsules
Participants were administered Diclofenac 35 mg capsules two times daily and could either be uptitrated to three times daily or remain at two times daily. Participants who were uptitrated to three times daily were allowed to downtitrate to two times daily either temporarily or permanently. Participants could change regimens between two and three times daily as often as needed, with the approval of the investigator.
|
|---|---|
|
Overall Study
STARTED
|
602
|
|
Overall Study
COMPLETED
|
360
|
|
Overall Study
NOT COMPLETED
|
242
|
Reasons for withdrawal
| Measure |
Diclofenac 35 mg Capsules
Participants were administered Diclofenac 35 mg capsules two times daily and could either be uptitrated to three times daily or remain at two times daily. Participants who were uptitrated to three times daily were allowed to downtitrate to two times daily either temporarily or permanently. Participants could change regimens between two and three times daily as often as needed, with the approval of the investigator.
|
|---|---|
|
Overall Study
Adverse Event
|
99
|
|
Overall Study
Lack of Efficacy
|
12
|
|
Overall Study
Non-compliance with trial drug
|
23
|
|
Overall Study
Withdrawal by Subject
|
49
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Protocol Violation
|
27
|
|
Overall Study
Lost to Follow-up
|
26
|
|
Overall Study
Other, including joint replacement
|
5
|
Baseline Characteristics
Open-Label Study of Diclofenac Capsules to Treat Osteoarthritis Pain
Baseline characteristics by cohort
| Measure |
Diclofenac 35 mg Capsules
n=601 Participants
Participants were administered Diclofenac 35 mg capsules two times daily and could either be uptitrated to three times daily or remain at two times daily. Participants who were uptitrated to three times daily were allowed to downtitrate to two times daily either temporarily or permanently. Participants could change regimens between two and three times daily as often as needed, with the approval of the investigator.
|
|---|---|
|
Age, Continuous
|
59.7 years
STANDARD_DEVIATION 8.89 • n=5 Participants
|
|
Sex: Female, Male
Female
|
372 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
229 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
40 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
561 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
6 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
89 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
506 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=5 Participants
|
|
Weight
|
87.93 kg
STANDARD_DEVIATION 17.005 • n=5 Participants
|
|
Height
|
169.25 cm
STANDARD_DEVIATION 9.898 • n=5 Participants
|
|
Body Mass Index
|
30.574 kg/m2
STANDARD_DEVIATION 4.9818 • n=5 Participants
|
|
Baseline Mental Component Score of the Short Form-36 Questionnaire
|
52.0 units on a scale
STANDARD_DEVIATION 9.60 • n=5 Participants
|
|
Baseline Physical Component Score of the Short Form-36 Questionnaire
|
39.5 units on a scale
STANDARD_DEVIATION 7.72 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 52/Early TerminationThe 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.
Outcome measures
| Measure |
Diclofenac 35 mg Capsules
n=601 Participants
Participants were administered Diclofenac 35 mg capsules two times daily and could either be uptitrated to three times daily or remain at two times daily. Participants who were uptitrated to three times daily were allowed to downtitrate to two times daily either temporarily or permanently. Participants could change regimens between two and three times daily as often as needed, with the approval of the investigator.
|
|---|---|
|
Safety of Diclofenac 35 mg Capsules as Assessed by the Incidence of Adverse Events From Baseline to Week 52 or Early Termination
Subjects with at least 1 TEAE
|
451 participants
|
|
Safety of Diclofenac 35 mg Capsules as Assessed by the Incidence of Adverse Events From Baseline to Week 52 or Early Termination
Subjects with at least 1 severe TEAE
|
41 participants
|
|
Safety of Diclofenac 35 mg Capsules as Assessed by the Incidence of Adverse Events From Baseline to Week 52 or Early Termination
Subjects with at least 1 serious adverse event
|
42 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Week 52/Early TerminationThe Short Form-36 is a validated 11-item health survey that assesses subject views about his/her functional health and well-being. The survey consists of 36 questions concerning daily or recent health-related activities and assesses 8 health domains using scaled scores. The physical component score is composed of a subset of the 8 health domains. Each scale is directly transformed into a 0 to 100 scale on the assumption that each question carries equal weight. A score of 0 is equal to maximum disability, and a score of 100 is equivalent to no disability.
Outcome measures
| Measure |
Diclofenac 35 mg Capsules
n=555 Participants
Participants were administered Diclofenac 35 mg capsules two times daily and could either be uptitrated to three times daily or remain at two times daily. Participants who were uptitrated to three times daily were allowed to downtitrate to two times daily either temporarily or permanently. Participants could change regimens between two and three times daily as often as needed, with the approval of the investigator.
|
|---|---|
|
Mean Short Form-36 Physical Component Summary Scores at Week 52/Early Termination (ET) and Change From Baseline to Week 52/ET
Mean score at Week 52/early termination (ET)
|
44.2 units on a scale
Standard Deviation 8.29
|
|
Mean Short Form-36 Physical Component Summary Scores at Week 52/Early Termination (ET) and Change From Baseline to Week 52/ET
Mean change from baseline to Week 52/ET
|
4.5 units on a scale
Standard Deviation 6.89
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Week 52/Early TerminationThe Short Form-36 is a validated 11-item health survey that assesses subject views about his/her functional health and well-being. The survey consists of 36 questions concerning daily or recent health-related activities and assesses 8 health domains using scaled scores. The mental component score is composed of a subset of the 8 health domains. Each scale is directly transformed into a 0 to 100 scale on the assumption that each question carries equal weight. A score of 0 is equal to maximum disability, and a score of 100 is equivalent to no disability.
Outcome measures
| Measure |
Diclofenac 35 mg Capsules
n=555 Participants
Participants were administered Diclofenac 35 mg capsules two times daily and could either be uptitrated to three times daily or remain at two times daily. Participants who were uptitrated to three times daily were allowed to downtitrate to two times daily either temporarily or permanently. Participants could change regimens between two and three times daily as often as needed, with the approval of the investigator.
|
|---|---|
|
Mean Short Form-36 Mental Component Summary Scores at Week 52/Early Termination (ET) and Change From Baseline to Week 52/ET
Mean score at Week 52/early termination (ET)
|
52.3 units on a scale
Standard Deviation 9.44
|
|
Mean Short Form-36 Mental Component Summary Scores at Week 52/Early Termination (ET) and Change From Baseline to Week 52/ET
Change from baseline to Week 52/ET
|
0.1 units on a scale
Standard Deviation 8.41
|
Adverse Events
Diclofenac 35 mg Capsules
Serious events: 42 serious events
Other events: 191 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Diclofenac 35 mg Capsules
n=601 participants at risk
Participants were administered Diclofenac 35 mg capsules two times daily and could either be uptitrated to three times daily or remain at two times daily. Participants who were uptitrated to three times daily were allowed to downtitrate to two times daily either temporarily or permanently. Participants could change regimens between two and three times daily as often as needed, with the approval of the investigator.
|
|---|---|
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Cardiac disorders
Angina pectoris
|
0.17%
1/601
|
|
Cardiac disorders
Angina unstable
|
0.17%
1/601
|
|
Cardiac disorders
Atrial fibrillation
|
0.17%
1/601
|
|
Cardiac disorders
Coronary artery disease
|
0.17%
1/601
|
|
Cardiac disorders
Coronary artery stenosis
|
0.17%
1/601
|
|
Cardiac disorders
Myocardial infarction
|
0.33%
2/601
|
|
Endocrine disorders
Hyperparathyroidism
|
0.17%
1/601
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.17%
1/601
|
|
Gastrointestinal disorders
Colitis
|
0.17%
1/601
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.17%
1/601
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.17%
1/601
|
|
Gastrointestinal disorders
Intestinal strangulation
|
0.17%
1/601
|
|
Cardiac disorders
Pancreatitis
|
0.17%
1/601
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.17%
1/601
|
|
General disorders
Chest pain
|
0.33%
2/601
|
|
Hepatobiliary disorders
Bile duct stone
|
0.17%
1/601
|
|
Infections and infestations
Diverticulitis
|
0.33%
2/601
|
|
Infections and infestations
Lobar pneumonia
|
0.17%
1/601
|
|
Infections and infestations
Pneumonia
|
0.17%
1/601
|
|
Infections and infestations
Pneumonia bacterial
|
0.17%
1/601
|
|
Infections and infestations
Post procedural infection
|
0.17%
1/601
|
|
Infections and infestations
Septic shock
|
0.17%
1/601
|
|
Infections and infestations
Urinary tract infection
|
0.17%
1/601
|
|
Injury, poisoning and procedural complications
Dural tear
|
0.17%
1/601
|
|
Injury, poisoning and procedural complications
Seroma
|
0.17%
1/601
|
|
Metabolism and nutrition disorders
Dehydration
|
0.17%
1/601
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.17%
1/601
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.33%
2/601
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.17%
1/601
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.50%
3/601
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.17%
1/601
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.17%
1/601
|
|
Nervous system disorders
Amyotrophic lateral sclerosis
|
0.17%
1/601
|
|
Nervous system disorders
Carotid artery stenosis
|
0.17%
1/601
|
|
Psychiatric disorders
Anxiety
|
0.17%
1/601
|
|
Psychiatric disorders
Depression
|
0.17%
1/601
|
|
Psychiatric disorders
Major depression
|
0.17%
1/601
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.33%
2/601
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.17%
1/601
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
0.17%
1/601
|
|
Surgical and medical procedures
Finger amputation
|
0.17%
1/601
|
|
Vascular disorders
Carotid artery stenosis
|
0.17%
1/601
|
|
Vascular disorders
Hypotension
|
0.17%
1/601
|
Other adverse events
| Measure |
Diclofenac 35 mg Capsules
n=601 participants at risk
Participants were administered Diclofenac 35 mg capsules two times daily and could either be uptitrated to three times daily or remain at two times daily. Participants who were uptitrated to three times daily were allowed to downtitrate to two times daily either temporarily or permanently. Participants could change regimens between two and three times daily as often as needed, with the approval of the investigator.
|
|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
7.8%
47/601
|
|
Nervous system disorders
Headache
|
7.7%
46/601
|
|
Infections and infestations
Urinary tract infection
|
7.3%
44/601
|
|
Gastrointestinal disorders
Diarrhea
|
6.2%
37/601
|
|
Infections and infestations
Nasopharyngitis
|
5.7%
34/601
|
|
Gastrointestinal disorders
Nausea
|
5.5%
33/601
|
Additional Information
Daniel Solorio, Executive Director of Clinical Operations
Iroko Pharmaceuticals, LLC
Phone: 267-546-3150
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place