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MoviPrep
Clinical Pharmacology
MoviPrep
The primary efficacy endpoint was the proportion of patients with effective colon cleansing as judged by the colonoscopist and one blinded gastroenterologist (on the basis of videotapes recorded during the colonoscopy). In case of a discrepancy between the colonoscopist and the blinded gastroenterologist, a second blinded gastroenterologist made the final efficacy determination.
The efficacy analysis included 280 adult patients who had an elective colonoscopy. Patients ranged in age from 21 to 76 years old (mean age about 53 years old) with 47% female and 53% male patients. Table 2 displays the results.
Table 2: Effectiveness of Overall Colon Cleansing in the
Study of MoviPrep® vs 90 mL Oral Sodium Phosphate Solution
| Responders A2 or B3(%) |
C4(%) | D5 ( %) | |
| MoviPrep ® (N =137) | 73.0 | 23.4 | 3.6 |
| 90 mL OSPS1 (N =143) | 64.4 | 29.4 | 6.3 |
| 1 OSPS is Oral Sodium Phosphate
Solution 2 A: empty and clean or clear liquid (transparent, yellow, or green) 3 B: brown liquid or semisolid remaining small amounts of stool, fully removable by suction or displaceable allowing a complete visualization of the underlying mucosa 4 C: semi solid only partially removable/displaceable stools; risk of incomplete examination of the underlying mucosa 5 D: heavy and hard stool making the segment examination uninterpretable and, consequently, the colonoscopy needed to be terminated MoviPrep's responder rate was not significantly higher than OSPS's responder rate. |
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Generic Name: PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, Ascorbic Acid
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