Trial Outcomes & Findings for Study of Meloxicam Capsules in Subjects With Osteoarthritis of the Knee or Hip (NCT NCT01801735)
NCT ID: NCT01801735
Last Updated: 2015-05-12
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
600 participants
Primary outcome timeframe
Baseline to Week 52/Early Termination
Results posted on
2015-05-12
Participant Flow
Participant milestones
| Measure |
Meloxicam 10 mg
Participants were administered Meloxicam 10 mg once daily for up to 52 weeks.
|
|---|---|
|
Overall Study
STARTED
|
600
|
|
Overall Study
COMPLETED
|
390
|
|
Overall Study
NOT COMPLETED
|
210
|
Reasons for withdrawal
| Measure |
Meloxicam 10 mg
Participants were administered Meloxicam 10 mg once daily for up to 52 weeks.
|
|---|---|
|
Overall Study
Adverse Event
|
79
|
|
Overall Study
Lack of Efficacy
|
28
|
|
Overall Study
Withdrawal by Subject
|
27
|
|
Overall Study
Protocol Violation
|
25
|
|
Overall Study
Lost to Follow-up
|
15
|
|
Overall Study
Non-compliance with Trial Drug
|
13
|
|
Overall Study
Physician Decision
|
3
|
|
Overall Study
Death
|
1
|
|
Overall Study
Other, including site closure
|
19
|
Baseline Characteristics
Study of Meloxicam Capsules in Subjects With Osteoarthritis of the Knee or Hip
Baseline characteristics by cohort
| Measure |
Meloxicam 10 mg
n=600 Participants
Participants were administered Meloxicam 10 mg once daily for up to 52 weeks.
|
|---|---|
|
Age, Continuous
|
61.7 years
STANDARD_DEVIATION 8.68 • n=5 Participants
|
|
Sex: Female, Male
Female
|
358 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
242 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
33 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
567 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
|
73 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
520 participants
n=5 Participants
|
|
Weight
|
88.50 kg
STANDARD_DEVIATION 18.28 • n=5 Participants
|
|
Height
|
169.56 cm
STANDARD_DEVIATION 10.17 • n=5 Participants
|
|
Body Mass Index
|
30.65 kg/m^2
STANDARD_DEVIATION 5.02 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 52/Early TerminationThe 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.
Outcome measures
| Measure |
Meloxicam 10 mg
n=600 Participants
Participants were administered Meloxicam 10 mg once daily for up to 52 weeks.
|
|---|---|
|
Safety of Meloxicam 10 mg as Assessed by the Incidence of Adverse Events From Baseline to Week 52 or Early Termination
Subjects with at least 1 TEAE
|
406 participants
|
|
Safety of Meloxicam 10 mg as Assessed by the Incidence of Adverse Events From Baseline to Week 52 or Early Termination
Subjects with at least 1 severe TEAE
|
23 participants
|
|
Safety of Meloxicam 10 mg as Assessed by the Incidence of Adverse Events From Baseline to Week 52 or Early Termination
Subjects with at least 1 serious adverse event
|
35 participants
|
|
Safety of Meloxicam 10 mg as Assessed by the Incidence of Adverse Events From Baseline to Week 52 or Early Termination
Subjects with at least 1 treatment-related TEAE
|
127 participants
|
|
Safety of Meloxicam 10 mg as Assessed by the Incidence of Adverse Events From Baseline to Week 52 or Early Termination
Subjects with AEs leading to discontinuation
|
79 participants
|
|
Safety of Meloxicam 10 mg as Assessed by the Incidence of Adverse Events From Baseline to Week 52 or Early Termination
Subjects who died
|
2 participants
|
Adverse Events
Meloxicam 10 mg
Serious events: 35 serious events
Other events: 65 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Meloxicam 10 mg
n=600 participants at risk
Participants were administered Meloxicam 10 mg once daily for up to 52 weeks.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.17%
1/600
|
|
Cardiac disorders
Angina pectoris
|
0.33%
2/600
|
|
Cardiac disorders
Cardiac failure acute
|
0.17%
1/600
|
|
Cardiac disorders
Cardiac failure congestive
|
0.17%
1/600
|
|
Cardiac disorders
Coronary artery disease
|
0.17%
1/600
|
|
Cardiac disorders
Coronary artery stenosis
|
0.17%
1/600
|
|
Gastrointestinal disorders
Diverticulum intestinal hemorrhagic
|
0.17%
1/600
|
|
Gastrointestinal disorders
Duodenal ulcer hemorrhage
|
0.17%
1/600
|
|
Gastrointestinal disorders
Gastric ulcer hemorrhage
|
0.17%
1/600
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.17%
1/600
|
|
General disorders
Chest pain
|
0.17%
1/600
|
|
General disorders
Non-cardiac chest pain
|
0.33%
2/600
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.17%
1/600
|
|
Infections and infestations
Appendicitis perforated
|
0.17%
1/600
|
|
Infections and infestations
Bronchitis
|
0.17%
1/600
|
|
Infections and infestations
Diverticulitis
|
0.33%
2/600
|
|
Infections and infestations
Lobar pneumonia
|
0.17%
1/600
|
|
Infections and infestations
Meningitis bacterial
|
0.17%
1/600
|
|
Infections and infestations
Sepsis
|
0.17%
1/600
|
|
Infections and infestations
Staphylococcal sepsis
|
0.17%
1/600
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.17%
1/600
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.17%
1/600
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.17%
1/600
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.17%
1/600
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.33%
2/600
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung squamous cell carcinoma, stage unspecified
|
0.17%
1/600
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.17%
1/600
|
|
Nervous system disorders
Carotid artery stenosis
|
0.17%
1/600
|
|
Nervous system disorders
Hemorrhagic cerebral infarction
|
0.17%
1/600
|
|
Nervous system disorders
Fourth nerve paralysis
|
0.17%
1/600
|
|
Renal and urinary disorders
Renal failure acute
|
0.33%
2/600
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.17%
1/600
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.17%
1/600
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.17%
1/600
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.33%
2/600
|
|
Surgical and medical procedures
Medical device removal
|
0.17%
1/600
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.17%
1/600
|
|
Vascular disorders
Hypertensive crisis
|
0.17%
1/600
|
Other adverse events
| Measure |
Meloxicam 10 mg
n=600 participants at risk
Participants were administered Meloxicam 10 mg once daily for up to 52 weeks.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.5%
33/600
|
|
Infections and infestations
Urinary tract infection
|
5.5%
33/600
|
Additional Information
Alexis Gomez, Director of Clinical Operations
Iroko Pharmaceuticals, LLC
Phone: 267-546-1426
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER