MOVIPREP Oral solution Ref.[50595] Active ingredients: Macrogol Potassium chloride Sodium chloride Sodium sulfate Vitamin C

Long-term studies in animals to evaluate the carcinogenic potential have not been performed with MoviPrep. Studies to evaluate potential for impairment of fertility or mutagenic potential have not been performed with MoviPrep.

The colon cleansing efficacy and safety of MoviPrep was evaluated in two randomized, actively-controlled, multi-center, investigator-blinded, phase 3 trials in patients scheduled to have an elective colonoscopy.

In the first study, patients were randomized to one of the following two colon preparation treatments: 1) 2 liters of MoviPrep with 1 additional liter of clear fluid split into two doses (during the evening before and the morning of the colonoscopy) and 2) 4 liters of polyethylene glycol plus electrolytes solution (4L PEG + E) split into two doses (during the evening before and the morning of the colonoscopy). Patients were allowed to have a morning breakfast, a light lunch, clear soup and/or plain yogurt for dinner. Dinner had to be completed at least one hour prior to initiation of the colon preparation administration.

The primary efficacy endpoint was the proportion of patients with effective colon cleansing as judged by blinded gastroenterologists on the basis of videotapes recorded during the colonoscopy.

The blinded gastroenterologists graded the colon cleansing twice (during introduction and withdrawal of the colonoscope) and the poorer of the two assessments was used in the primary efficacy analysis.

The efficacy analysis included 308 adult patients who had an elective colonoscopy. Patients ranged in age from 18 to 88 years old (mean age about 59 years old) with 52% female and 48% male patients. Table 1 displays the results.

Table 1. Effectiveness of Overall Colon Cleansing in the Study of MoviPrep vs 4 Liter Polyethylene Glycol plus Electrolytes Solution:

¹ 4L PEG + E is 4 Liter Polyethylene Glycol plus Electrolytes Solution
² A: colon empty and clean or presence of clear liquid, but easily removed by suction
³ B: brown liquid or semisolid remaining amounts of stool, fully removable by suction or displaceable, thus allowing a complete visualization of the gut mucosa
⁴ C: semisolid amounts of stool, only partially removable with a risk of incomplete visualization of the gut mucosa
⁵ D: semisolid or solid amounts of stool; consequently colonoscopy incomplete or needed to be terminated. 4 L PEG+E’s responder rate was not significantly higher than MoviPrep’s responder rate.

In the second study, patients were randomized to one of the following two colon preparation treatments: 1) 2 liters of MoviPrep with 1 additional liter of clear fluid in the evening prior to the colonoscopy and 2) 90 mL of oral sodium phosphate solution (90 mL OSPS) with at least 2 liters of additional clear fluid during the day and evening prior to the colonoscopy. Patients randomized to MoviPrep therapy were allowed to have a morning breakfast; a light lunch; and clear soup and/or plain yogurt for dinner. Dinner had to be completed at least one hour prior to initiation of the colon preparation administration.

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 90mL Oral Sodium Phosphate Solution:

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.