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A Phase III Comparison Study of NPF-08 in Patients Who Receive Colonoscopy

A Phase III Comparison Study of NPF-08 in Patients Who Receive Colonoscopy

602

Males and females accounted for 58.0% and 42.0% of all subjects, respectively, with a mean age of 53.5 years, a mean body weight of 64.43 kg, and a mean height of 164.79 cm. There were no significant differences in any factors among the treatment groups, and there was no imbalance that required adjustment to analyze the efficacy or safety.

Adverse events (AEs) occurred in 9.4% (19/202 subjects) in the NPF-08 two-day divided administration group, 4.0% (8/200 subjects) in the NPF-08 one-day administration group, and 7.5% (15/200 subjects) in the Moviprep group. Adverse drug reactions (ADRs) occurred in 6.4% (13/202 subjects) in the NPF-08 two-day divided administration group, 0.5% (1/200 subjects) in the NPF-08 one-day administration group, and 4.5% (9/200 subjects) in the Moviprep group.

The efficacy rate for the overall bowel cleansing effect evaluated by the image evaluation committee according to the Scale for evaluating the quality of bowel cleansing (95% CI), which was the primary endpoint, was 92.1% (87.5 to 95.4) in the NPF-08 two-day divided administration group, 97.0% (93.6 to 98.9) in the NPF-08 one-day administration group, and 95.0% (91.0 to 97.6) in the Moviprep group. The differences in efficacy rate between the NPF-08 two-day divided administration group and NPF-08 one-day administration group versus the Moviprep group (two-sided 95% CI) were -2.9% (-7.7 to 1.9) and 2.0% (-1.8 to 5.8), respectively. Since the lower 95% confidence limit for the difference in efficacy rate from the Moviprep group exceeded the non-inferiority margin of -10% in both NPF-08 one-day administration and two-day divided administration groups, the non-inferiority of NPF-08 one-day administration and NPF-08 two-day divided administration to Moviprep was demonstrated. The superiority tests revealed that the lower 95% confidence limit for the difference in efficacy rate between the NPF-08 one-day administration group and the Moviprep group did not exceed 0%, failing to demonstrate the superiority. Accordingly, the superiority was not tested in the NPF-08 two-day divided administration group.

In subjects undergoing colonoscopy, NPF-08 administered on the day of colonoscopy or in divided doses over 2 days was as effective as Mooviprep administered on the day of colonoscopy. As for the safety, there were no new concerns or clinically relevant events in any treatment groups.

Jan. 21, 2021

https://onlinelibrary.wiley.com/doi/10.1111/den.13930

No

Nihon Pharmaceutical Co., Ltd

8-1,Akashi-cho, Chuo-ku,

kaihatsu@nihon-pharm.co.jp

Nihon Pharmaceutical Co., Ltd

8-1,Akashi-cho, Chuo-ku,

+81-3-5148-7574

kaihatsu@nihon-pharm.co.jp

completed

Jan. 05, 2019

Interventional

Active-controlled, randomized, endoscopist/imaging rater-blinded, multicenter, parallel-group study

other

3

1. Japanese men and women aged 20 years or older at obtaining the written informed consent.
2. Patients who require colonoscopy(except for emergency colonoscopy).
3. Patients who have the ability to consent and submit the written informed consent by themselves.

1. Patients who have or are suspected to have gastrointestinal obstruction.
2. Patients who have or are suspected to have intestinal perforation.
3. Patients who have or are suspected to have toxic megacolon.
4. Patients who have or are suspected to have gastric evacuation disorder (gastroparesis).
5. Patients with intestinal stenosis or high-grade constipation (stool frequency of 2 or less in a week or who have used laxative on a daily basis).
6. Patients with vomiting reflex or in whom accidental ingestion may occur.
7. Patients with a history of gastrointestinal surgery (except for appendicectomy).
8. Patients who were decided as glucose-6-phosphate dehydrogenase (G-6-PD) deficiency.
9. Patients with renal impairment (urea nitrogen: 25mg/dL or more, or creatinine: 2mg/dL or more)
10. Patients with hepatic dysfunction (total bilirubin: 3.0mg/dL or more, ALT: 100IU/L or more or AST: 100IU/L or more)
11. Patients who have undergone or require therapy due to high-grade cardiac disease (including angina pectoris or myocardial infarction)
12. Patients with high risk of arrhythmia (with a history or complications of QT prolongation, myocardial infarction, angina pectoris, cardiac failure or cardiomyopathy)
13. Patients with dehydration.
14. Patients who were diagnosed with active inflammatory bowel disease at screening period.
15. Inpatients due to the reasons other than endoscopy large bowel.
16. Patients who have undergone nutritional control using total parenteral nutrition or enteral nutrition.
17. Women who are or may be pregnant, lactating or wish to become pregnant during the trial period.
18. Patients with a history or high-risk of seizure.
19. Patients with a history of shock or hypersensitivity for the active ingredient of the investigational product.
20. Patients who have received the other investigational product within 4 months before the written informed consent or who are participating in the other clinical trials.
21. Patients in whom Investigator/Sub-Investigator decided not to be eligible for this trial.

Both

Patients Who Receive Colonoscopy

investigational material(s)
Generic name etc : NPF-08
INN of investigational material : -
Therapeutic category code : 235 Purgatives and clysters
Dosage and Administration for Investigational material : Oral

control material(s)
Generic name etc : Moviprep
INN of investigational material : -
Therapeutic category code : 235 Purgatives and clysters
Dosage and Administration for Investigational material : Oral

efficacy
The efficacy rate of overall intestinal cleansing effect

efficacy
Colon cleansing degree by site
Evaluation based on Ottawa Bowel Preparation Scale
Time from the initiation of dosing the investigational product to the completion of colon cleansing on the day of endoscopy.

Dec. 19, 2018