Study of NPF-08 in Patients Who Receive Colonoscopy

Nihon Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Patients Who Receive Colonoscopy

Treatments: Drug: Moviprep（1-day treatment）; Drug: NPF-08 （1-day treatment）; Drug: NPF-08 （2-day split dose）

Study type: Interventional

Funder types: Industry

Identifiers

NCT03794310

NPF-08-01/C-01

Details and patient eligibility

About

To study non-inferiority of intestinal cleansing effect in both NPF-08 1-day treatment group and NPF-08 2-day split dose group to the cleansing effect in Moviprep® 1-day treatment group, for the subjects who will receive endoscopy large bowel. If the non-inferiority will be validated, superiority of intestinal cleansing effect in both groups of NPF-08 will be studied.

Furthermore, for the assessment of safety of NPF-08, the adverse events and adverse drug reactions observed after the administration to post-examination period will be studied, compared to those at Moviprep® 1-day treatment group.

Enrollment: 632 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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632 participants in 3 patient groups

NPF-08 （1-day treatment）

Experimental group

Treatment:

Drug: NPF-08 （1-day treatment）

NPF-08 （2-day split dose）

Experimental group

Treatment:

Drug: NPF-08 （2-day split dose）

Moviprep（1-day treatment）

Active Comparator group

Treatment:

Drug: Moviprep（1-day treatment）