Mobic Clinical Trials and Studies
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Mobic Clinical Trials and Studies
The Mobic phase 2/3 clinical trial database includes 10,122 patients treated with Mobic 7.5 mg/day and 3,505 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. 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. Table B depicts adverse events that occurred in 2% of the Mobic treatment groups.
Table B Adverse Events (%) Occurring in 2% of Mobic Patients in a 12-Week Osteoarthritis Placebo and Active-Controlled Trial
| Body System / Adverse Event | 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 |
1 WHO preferred terms edema, edema dependent, edema peripheral and edema legs combined
2 WHO< preferred terms rash, rash erythematous and rash maculo-papular combined
The adverse events that occurred with Mobic in 2% of patients treated short-term (4-6 weeks) and long-term (6 months) in active-controlled osteoarthritis trials are presented in Table C.
Table C Adverse Events (%) Occurring in 2% of Mobic Patients in 4 to 6 Weeks and 6 Month Active-Controlled Osteoarthritis Trials
| Body System / Adverse Event | 4-6 Weeks 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 | ||||
| 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 |
| Musculo-Skeletal | ||||
| 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 |
1 WHO preferred terms edema, edema dependent, edema peripheral and edema legs combined
2 WHO preferred terms rash, rash erythematous and rash maculo-papular combined
As with other Anti-Inflammatory Drugs">NSAIDs, higher doses of Mobic (e.g., chronic daily 30 mg dose) were associated with an increased risk of serious GI events, therefore the daily dose of Mobic should not exceed 15 mg. The following is a list of adverse drug reactions occurring in < 2% of patients receiving Mobic in clinical trials involving approximately 15,400 patients. Adverse reactions reported only in worldwide post-marketing experience or the literature are shown in italics and are considered rare (< 0.1%).
| Body as a Whole: | allergic reaction, anaphylactoid reactions including shock, 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: | agranulocytosis, leukopenia, purpura, thrombocytopenia |
| Liver and Biliary System: | ALT increased, AST increased, bilirubinema, GGT increased, hepatitis, jaundice, liver failure |
| Metabolic and Nutritional: | dehydration |
| Psychiatric Disorders: | abnormal dreaming, anxiety, appetite increased, confusion, depression, nervousness, somnolence |
| Respiratory: | asthma, bronchospasm, dyspnea |
| Skin and Appendages: | alopecia, angioedema, bullous eruption, erythema multiforme, photosensitivity reaction, pruritus, Stevens-Johnson syndrome, sweating increased, toxic epidermal necrolysis, urticaria |
| Special Senses: | abnormal vision, conjunctivitis, taste perversion, tinnitus |
| Urinary System: | albuminuria, BUN increased, creatinine increased, hematuria, interstitial nephritis, renal failure |
