Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of Meloxicam Capsules in Subjects With Osteoarthritis of the Knee or Hip

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: NCT01801735
Recruitment Status : Completed
First Posted : March 1, 2013
Results First Posted : May 12, 2015
Last Update Posted : May 12, 2015
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: Meloxicam Test Capsules
Enrollment 600
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Meloxicam 10 mg
Hide Arm/Group Description Participants were administered Meloxicam 10 mg once daily for up to 52 weeks.
Period Title: Overall Study
Started 600
Completed 390
Not Completed 210
Reason Not Completed
Adverse Event             79
Lack of Efficacy             28
Withdrawal by Subject             27
Protocol Violation             25
Lost to Follow-up             15
Non-compliance with Trial Drug             13
Physician Decision             3
Death             1
Other, including site closure             19
Arm/Group Title Meloxicam 10 mg
Hide Arm/Group Description Participants were administered Meloxicam 10 mg once daily for up to 52 weeks.
Overall Number of Baseline Participants 600
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 600 participants
61.7  (8.68)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 600 participants
Female
358
  59.7%
Male
242
  40.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 600 participants
Hispanic or Latino
33
   5.5%
Not Hispanic or Latino
567
  94.5%
Unknown or Not Reported
0
   0.0%
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 600 participants
American Indian or Alaska Native 2
Asian 6
Black or African-American 73
Native Hawaiian or Other Pacific Islander 1
White 520
[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 600 participants
88.50  (18.28)
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 600 participants
169.56  (10.17)
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 600 participants
30.65  (5.02)
1.Primary Outcome
Title Safety of Meloxicam 10 mg as Assessed by the Incidence of Adverse Events From Baseline to Week 52 or Early Termination
Hide Description The safety of Meloxicam 10 mg was assessed by the number of subjects with treatment-emergent adverse events (TEAEs), severe TEAEs, serious adverse events, treatment-related TEAEs, and adverse events (AEs) leading to discontinuation and subjects who died.
Time Frame Baseline to Week 52/Early Termination
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Meloxicam 10 mg
Hide Arm/Group Description:
Participants were administered Meloxicam 10 mg once daily for up to 52 weeks.
Overall Number of Participants Analyzed 600
Measure Type: Number
Unit of Measure: participants
Subjects with at least 1 TEAE 406
Subjects with at least 1 severe TEAE 23
Subjects with at least 1 serious adverse event 35
Subjects with at least 1 treatment-related TEAE 127
Subjects with AEs leading to discontinuation 79
Subjects who died 2
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Meloxicam 10 mg
Hide Arm/Group Description Participants were administered Meloxicam 10 mg once daily for up to 52 weeks.
All-Cause Mortality
Meloxicam 10 mg
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Meloxicam 10 mg
Affected / at Risk (%)
Total   35/600 (5.83%) 
Blood and lymphatic system disorders   
Anemia  1/600 (0.17%) 
Cardiac disorders   
Angina pectoris  2/600 (0.33%) 
Cardiac failure acute  1/600 (0.17%) 
Cardiac failure congestive  1/600 (0.17%) 
Coronary artery disease  1/600 (0.17%) 
Coronary artery stenosis  1/600 (0.17%) 
Gastrointestinal disorders   
Diverticulum intestinal hemorrhagic  1/600 (0.17%) 
Duodenal ulcer hemorrhage  1/600 (0.17%) 
Gastric ulcer hemorrhage  1/600 (0.17%) 
Gastroesophageal reflux disease  1/600 (0.17%) 
General disorders   
Chest pain  1/600 (0.17%) 
Non-cardiac chest pain  2/600 (0.33%) 
Hepatobiliary disorders   
Drug-induced liver injury  1/600 (0.17%) 
Infections and infestations   
Appendicitis perforated  1/600 (0.17%) 
Bronchitis  1/600 (0.17%) 
Diverticulitis  2/600 (0.33%) 
Lobar pneumonia  1/600 (0.17%) 
Meningitis bacterial  1/600 (0.17%) 
Sepsis  1/600 (0.17%) 
Staphylococcal sepsis  1/600 (0.17%) 
Injury, poisoning and procedural complications   
Post procedural complication  1/600 (0.17%) 
Road traffic accident  1/600 (0.17%) 
Spinal compression fracture  1/600 (0.17%) 
Musculoskeletal and connective tissue disorders   
Costochondritis  1/600 (0.17%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Breast cancer  2/600 (0.33%) 
Lung squamous cell carcinoma, stage unspecified  1/600 (0.17%) 
Transitional cell carcinoma  1/600 (0.17%) 
Nervous system disorders   
Carotid artery stenosis  1/600 (0.17%) 
Hemorrhagic cerebral infarction  1/600 (0.17%) 
Fourth nerve paralysis  1/600 (0.17%) 
Renal and urinary disorders   
Renal failure acute  2/600 (0.33%) 
Respiratory, thoracic and mediastinal disorders   
Acute respiratory distress syndrome  1/600 (0.17%) 
Acute respiratory failure  1/600 (0.17%) 
Chronic obstructive pulmonary disease  1/600 (0.17%) 
Pulmonary embolism  2/600 (0.33%) 
Surgical and medical procedures   
Medical device removal  1/600 (0.17%) 
Vascular disorders   
Aortic aneurysm rupture  1/600 (0.17%) 
Hypertensive crisis  1/600 (0.17%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Meloxicam 10 mg
Affected / at Risk (%)
Total   65/600 (10.83%) 
Infections and infestations   
Urinary tract infection  33/600 (5.50%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  33/600 (5.50%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
Investigator is required to submit any materials describing the results of the study at the site to sponsor for review not less than 30 days prior to publication and agrees to remove any of the Sponsor's confidential information. Sponsor also retains right to delay publication for an additional 60 day period to allow time for filing of patent applications.
Results Point of Contact
Name/Title: Alexis Gomez, Director of Clinical Operations
Organization: Iroko Pharmaceuticals, LLC
Phone: 267-546-1426
Responsible Party: Iroko Pharmaceuticals, LLC
ClinicalTrials.gov Identifier: NCT01801735     History of Changes
Other Study ID Numbers: MEL3-12-03
First Submitted: February 21, 2013
First Posted: March 1, 2013
Results First Submitted: April 24, 2015
Results First Posted: May 12, 2015
Last Update Posted: May 12, 2015