Trepoxicam-7.5 (Page 2 of 5)
6.1 Clinical Trials Experience
6 ADVERSE REACTIONS
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The following serious adverse reactions are discussed elsewhere in the labeling: Cardiovascular thrombotic events [see Boxed Warning and Warnings and Precautions (5.1)] Gastrointestinal effects – risk of GI ulceration, bleeding, and perforation [see Boxed Warning and Warnings and Precautions (5.2)] Hepatic effects [see Warnings and Precautions (5.3)] Hypertension [see Warnings and Precautions (5.4)] Congestive heart failure and edema [see Warnings and Precautions (5.5)] Renal effects [see Warnings and Precautions (5.6)] Anaphylactoid reactions [see Warnings and Precautions (5.7)] Adverse skin reactions [see Warnings and Precautions (5.8)] 6.1 Clinical Trials Experience Adults Osteoarthritis and Rheumatoid Arthritis The MOBIC Phase 2/3 clinical trial database includes 10,122 OA patients and 1012 RA patients treated with MOBIC 7.5 mg/day, 3505 OA patients and 1351 RA patients treated with MOBIC 15 mg/day. MOBIC at these doses was administered to 661 patients for at least 6 months and to 312 patients for at least one year. Approximately 10,500 of these patients were treated in ten placebo- and/or active-controlled osteoarthritis trials and 2363 of these patients were treated in ten placebo- and/or active-controlled rheumatoid arthritis trials. Gastrointestinal (GI) adverse events were the most frequently reported adverse events in all treatment groups across MOBIC trials. A 12-week multicenter, double-blind, randomized trial was conducted in patients with osteoarthritis of the knee or hip to compare the efficacy and safety of MOBIC with placebo and with an active control. Two 12-week multicenter, double-blind, randomized trials were conducted in patients with rheumatoid arthritis to compare the efficacy and safety of MOBIC with placebo. Table 1a depicts adverse events that occurred in greater than or equal to 2% of the MOBIC treatment groups in a 12-week placebo- and active-controlled osteoarthritis trial. Table 1b depicts adverse events that occurred in greater than or equal to 2% of the MOBIC treatment groups in two 12-week placebo-controlled rheumatoid arthritis trials.
| Placebo | MOBIC 7.5 mg daily | MOBIC 15 mg daily | Diclofenac 100 mg daily | |
| No. of Patients | 157 | 154 | 156 | 153 |
| Gastrointestinal | 17.2 | 20.1 | 17.3 | 28.1 |
| Abdominal pain | 2.5 | 1.9 | 2.6 | 1.3 |
| Diarrhea | 3.8 | 7.8 | 3.2 | 9.2 |
| Dyspepsia | 4.5 | 4.5 | 4.5 | 6.5 |
| Flatulence | 4.5 | 3.2 | 3.2 | 3.9 |
| Nausea | 3.2 | 3.9 | 3.8 | 7.2 |
| Body as a Whole | ||||
| Accident household | 1.9 | 4.5 | 3.2 | 2.6 |
| Edema1 | 2.5 | 1.9 | 4.5 | 3.3 |
| Fall | 0.6 | 2.6 | 0.0 | 1.3 |
| Influenza-like symptoms | 5.1 | 4.5 | 5.8 | 2.6 |
| Central and Peripheral Nervous System | ||||
| Dizziness | 3.2 | 2.6 | 3.8 | 2.0 |
| Headache | 10.2 | 7.8 | 8.3 | 5.9 |
| Respiratory | ||||
| Pharyngitis | 1.3 | 0.6 | 3.2 | 1.3 |
| Upper respiratory tract infection | 1.9 | 3.2 | 1.9 | 3.3 |
| Skin | ||||
| Rash2 | 2.5 | 2.6 | 0.6 | 2.0 |
| Placebo | MOBIC 7.5 mg daily | MOBIC 15 mg daily | |
| No. of Patients | 469 | 481 | 477 |
| Gastrointestinal Disorders | 14.1 | 18.9 | 16.8 |
| Abdominal pain NOS2 | 0.6 | 2.9 | 2.3 |
| Dyspeptic signs and symptoms1 | 3.8 | 5.8 | 4.0 |
| Nausea2 | 2.6 | 3.3 | 3.8 |
| General Disorders and Administration Site Conditions | |||
| Influenza-like illness2 | 2.1 | 2.9 | 2.3 |
| Infection and Infestations | |||
| Upper respiratory tract infections-pathogen class unspecified1 | 4.1 | 7.0 | 6.5 |
| Musculoskeletal and Connective Tissue Disorders | |||
| Joint related signs and symptoms1 | 1.9 | 1.5 | 2.3 |
| Nervous System Disorders | |||
| Headaches NOS2 | 6.4 | 6.4 | 5.5 |
| Skin and Subcutaneous Tissue Disorders | |||
| Rash NOS2 | 1.7 | 1.0 | 2.1 |
| 4 to 6 Weeks Controlled Trials | 4 to 6 Weeks Controlled Trials | 6 Month Controlled Trials | 6 Month Controlled Trials | |
| MOBIC 7.5 mg daily | MOBIC 15 mg daily | MOBIC 7.5 mg daily | MOBIC 15 mg daily | |
| No. of Patients | 8955 | 256 | 169 | 306 |
| Gastrointestinal | 11.8 | 18.0 | 26.6 | 24.2 |
| Abdominal pain | 2.7 | 2.3 | 4.7 | 2.9 |
| Constipation | 0.8 | 1.2 | 1.8 | 2.6 |
| Diarrhea | 1.9 | 2.7 | 5.9 | 2.6 |
| Dyspepsia | 3.8 | 7.4 | 8.9 | 9.5 |
| Flatulence | 0.5 | 0.4 | 3.0 | 2.6 |
| Nausea | 2.4 | 4.7 | 4.7 | 7.2 |
| Vomiting | 0.6 | 0.8 | 1.8 | 2.6 |
| Body as a Whole | ||||
| Accident household | 0.0 | 0.0 | 0.6 | 2.9 |
| Edema1 | 0.6 | 2.0 | 2.4 | 1.6 |
| Pain | 0.9 | 2.0 | 3.6 | 5.2 |
| Central and Peripheral Nervous System | ||||
| Dizziness | 1.1 | 1.6 | 2.4 | 2.6 |
| Headache | 2.4 | 2.7 | 3.6 | 2.6 |
| Hematologic | ||||
| Anemia | 0.1 | 0.0 | 4.1 | 2.9 |
| Musculoskeletal | ||||
| Arthralgia | 0.5 | 0.0 | 5.3 | 1.3 |
| Back pain | 0.5 | 0.4 | 3.0 | 0.7 |
| Psychiatric | ||||
| Insomnia | 0.4 | 0.0 | 3.6 | 1.6 |
| Respiratory | ||||
| Coughing | 0.2 | 0.8 | 2.4 | 1.0 |
| Upper respiratory tract infection | 0.2 | 0.0 | 8.3 | 7.5 |
| Skin | ||||
| Pruritus | 0.4 | 1.2 | 2.4 | 0.0 |
| Rash2 | 0.3 | 1.2 | 3.0 | 1.3 |
| Urinary | ||||
| Micturition frequency | 0.1 | 0.4 | 2.4 | 1.3 |
| Urinary tract infection | 0.3 | 0.4 | 4.7 | 6.9 |
| Body as a Whole | allergic reaction, face edema, fatigue, fever, hot flushes, malaise, syncope, weight decrease, weight increase |
| Cardiovascular | angina pectoris, cardiac failure, hypertension, hypotension, myocardial infarction, vasculitis |
| Central and Peripheral Nervous System | convulsions, paresthesia, tremor, vertigo |
| Gastrointestinal | colitis, dry mouth, duodenal ulcer, eructation, esophagitis, gastric ulcer, gastritis, gastroesophageal reflux, gastrointestinal hemorrhage, hematemesis, hemorrhagic duodenal ulcer, hemorrhagic gastric ulcer, intestinal perforation, melena, pancreatitis, perforated duodenal ulcer, perforated gastric ulcer, stomatitis ulcerative |
| Heart Rate and Rhythm | arrhythmia, palpitation, tachycardia |
| Hematologic | leukopenia, purpura, thrombocytopenia |
| Liver and Biliary System | ALT increased, AST increased, bilirubinemia, GGT increased, hepatitis |
| Metabolic a nd Nutritional | dehydration |
| Psychiatric | abnormal dreaming, anxiety, appetite increased, confusion, depression, nervousness, somnolence |
| Respiratory | asthma, bronchospasm, dyspnea |
| Skin and Appendages | alopecia, angioedema, bullous eruption, photosensitivity reaction, pruritus, sweating increased, urticaria |
| Special Senses | abnormal vision, conjunctivitis, taste perversion, tinnitus |
| Urinary System | albuminuria, BUN increased, creatinine increased, hematuria, renal failure |
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