Clinical Trials / Clinical Information
This information is intended for U.S. residents only.
Clinical Trials
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 (4 L 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 the day before their colonoscopy. 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 study blinded gastroenterologists on the basis of videotapes recorded during the colonoscopy. The study
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
|
|
Responders
A2 or B3 (%) |
C4(%) |
D5(%) |
| MoviPrep® (N=153) |
88.9 |
9.8 |
1.3 |
| 4 L PEG + E1 (N=155) |
94.8 |
4.5 |
0.6 |
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) 90mL 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 the day before their colonoscopy. 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 90 mL Oral Sodium Phosphate Solution
| |
Responders
A2 or B3 (%) |
C4(%) |
D5(%) |
| MoviPrep® (N=137) |
73.0 |
23.4 |
3.6 |
| 90 nL OSPS1 (N=143) |
64.4 |
29.4 |
6.3 |
MoviPrep® (PEG-3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate and ascorbic acid for oral solution) is indicated for cleansing of the
colon as a preparation for colonoscopy in adults 18 years of age or older. MoviPrep is contraindicated in patients who have had a severe hypersensitivity reaction
to any of its components. MoviPrep should be used with caution in patients using concomitant medications that increase the risk of electrolyte abnormalities, in patients with known or suspected hyponatremia,
severe ulcerative colitis, ileus, gastrointestinal obstruction or perforation, gastric retention, toxic colitis, toxic megacolon, or glucose-6-phosphate dehydrogenase deficiency. In clinical trials, abdominal
distention, anal discomfort, thirst, nausea, and abdominal pain were the most common adverse reactions to MoviPrep administration. MoviPrep contains a maximum of 2.33 mg of phenylalanine per treatment.
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