Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Open-Label Study of Diclofenac Capsules to Treat Osteoarthritis Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01510912
Recruitment Status : Completed
First Posted : January 18, 2012
Results First Posted : May 9, 2014
Last Update Posted : May 9, 2014
Sponsor:
Information provided by (Responsible Party):
Iroko Pharmaceuticals, LLC

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Osteoarthritis
Intervention Drug: Diclofenac
Enrollment 602
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Diclofenac 35 mg Capsules
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 602
Completed 360
Not Completed 242
Reason Not Completed
Adverse Event             99
Lack of Efficacy             12
Non-compliance with trial drug             23
Withdrawal by Subject             49
Physician Decision             1
Protocol Violation             27
Lost to Follow-up             26
Other, including joint replacement             5
Arm/Group Title Diclofenac 35 mg Capsules
Hide Arm/Group Description 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 Number of Baseline Participants 601
Hide Baseline Analysis Population Description
The safety population included all subjects who were treated with at least 1 dose of trial drug. Of the 602 subjects who started the study, 601 received at least 1 dose of trial drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 601 participants
59.7  (8.89)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 601 participants
Female
372
  61.9%
Male
229
  38.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 601 participants
Hispanic or Latino
40
   6.7%
Not Hispanic or Latino
561
  93.3%
Unknown or Not Reported
0
   0.0%
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 601 participants
American Indian or Alaska Native 2
Asian 6
Black or African American 89
White 506
Other 1
[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 601 participants
87.93  (17.005)
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 601 participants
169.25  (9.898)
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m2
Number Analyzed 601 participants
30.574  (4.9818)
Baseline Mental Component Score of the Short Form-36 Questionnaire   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 601 participants
52.0  (9.60)
[1]
Measure Description: The 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.
Baseline Physical Component Score of the Short Form-36 Questionnaire   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 601 participants
39.5  (7.72)
[1]
Measure Description: The 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.
1.Primary Outcome
Title Safety of Diclofenac 35 mg Capsules as Assessed by the Incidence of Adverse Events From Baseline to Week 52 or Early Termination
Hide Description 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.
Time Frame Baseline to Week 52/Early Termination
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Diclofenac 35 mg Capsules
Hide Arm/Group Description:
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 Number of Participants Analyzed 601
Measure Type: Number
Unit of Measure: participants
Subjects with at least 1 TEAE 451
Subjects with at least 1 severe TEAE 41
Subjects with at least 1 serious adverse event 42
2.Other Pre-specified Outcome
Title Mean Short Form-36 Physical Component Summary Scores at Week 52/Early Termination (ET) and Change From Baseline to Week 52/ET
Hide Description The 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.
Time Frame Baseline to Week 52/Early Termination
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Diclofenac 35 mg Capsules
Hide Arm/Group Description:
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 Number of Participants Analyzed 555
Mean (Standard Deviation)
Unit of Measure: units on a scale
Mean score at Week 52/early termination (ET) 44.2  (8.29)
Mean change from baseline to Week 52/ET 4.5  (6.89)
3.Other Pre-specified Outcome
Title Mean Short Form-36 Mental Component Summary Scores at Week 52/Early Termination (ET) and Change From Baseline to Week 52/ET
Hide Description The 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.
Time Frame Baseline to Week 52/Early Termination
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Diclofenac 35 mg Capsules
Hide Arm/Group Description:
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 Number of Participants Analyzed 555
Mean (Standard Deviation)
Unit of Measure: units on a scale
Mean score at Week 52/early termination (ET) 52.3  (9.44)
Change from baseline to Week 52/ET 0.1  (8.41)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Diclofenac 35 mg Capsules
Hide Arm/Group Description 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.
All-Cause Mortality
Diclofenac 35 mg Capsules
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Diclofenac 35 mg Capsules
Affected / at Risk (%)
Total   42/601 (6.99%) 
Cardiac disorders   
Angina pectoris  1/601 (0.17%) 
Angina unstable  1/601 (0.17%) 
Atrial fibrillation  1/601 (0.17%) 
Coronary artery disease  1/601 (0.17%) 
Coronary artery stenosis  1/601 (0.17%) 
Myocardial infarction  2/601 (0.33%) 
Pancreatitis  1/601 (0.17%) 
Endocrine disorders   
Hyperparathyroidism  1/601 (0.17%) 
Gastrointestinal disorders   
Abdominal hernia  1/601 (0.17%) 
Colitis  1/601 (0.17%) 
Diverticular perforation  1/601 (0.17%) 
Gastrointestinal pain  1/601 (0.17%) 
Intestinal strangulation  1/601 (0.17%) 
Small intestinal obstruction  1/601 (0.17%) 
General disorders   
Chest pain  2/601 (0.33%) 
Hepatobiliary disorders   
Bile duct stone  1/601 (0.17%) 
Infections and infestations   
Diverticulitis  2/601 (0.33%) 
Lobar pneumonia  1/601 (0.17%) 
Pneumonia  1/601 (0.17%) 
Pneumonia bacterial  1/601 (0.17%) 
Post procedural infection  1/601 (0.17%) 
Septic shock  1/601 (0.17%) 
Urinary tract infection  1/601 (0.17%) 
Injury, poisoning and procedural complications   
Dural tear  1/601 (0.17%) 
Seroma  1/601 (0.17%) 
Metabolism and nutrition disorders   
Dehydration  1/601 (0.17%) 
Musculoskeletal and connective tissue disorders   
Intervertebral disc protrusion  1/601 (0.17%) 
Lumbar spinal stenosis  2/601 (0.33%) 
Muscle spasms  1/601 (0.17%) 
Osteoarthritis  3/601 (0.50%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Colon cancer metastatic  1/601 (0.17%) 
Prostate cancer  1/601 (0.17%) 
Nervous system disorders   
Amyotrophic lateral sclerosis  1/601 (0.17%) 
Carotid artery stenosis  1/601 (0.17%) 
Psychiatric disorders   
Anxiety  1/601 (0.17%) 
Depression  1/601 (0.17%) 
Major depression  1/601 (0.17%) 
Respiratory, thoracic and mediastinal disorders   
Chronic obstructive pulmonary disease  2/601 (0.33%) 
Pulmonary embolism  1/601 (0.17%) 
Skin and subcutaneous tissue disorders   
Cellulitis  1/601 (0.17%) 
Surgical and medical procedures   
Finger amputation  1/601 (0.17%) 
Vascular disorders   
Carotid artery stenosis  1/601 (0.17%) 
Hypotension  1/601 (0.17%) 
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 Capsules
Affected / at Risk (%)
Total   191/601 (31.78%) 
Gastrointestinal disorders   
Diarrhea  37/601 (6.16%) 
Nausea  33/601 (5.49%) 
Infections and infestations   
Upper respiratory tract infection  47/601 (7.82%) 
Urinary tract infection  44/601 (7.32%) 
Nasopharyngitis  34/601 (5.66%) 
Nervous system disorders   
Headache  46/601 (7.65%) 
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: NCT01510912     History of Changes
Other Study ID Numbers: DIC3-08-06
First Submitted: January 12, 2012
First Posted: January 18, 2012
Results First Submitted: April 8, 2014
Results First Posted: May 9, 2014
Last Update Posted: May 9, 2014