Patients Who Receive ColonoscopyPhase 3NCT03794310

Study of NPF-08 in Patients Who Receive Colonoscopy

A Phase 3 study testing NPF-08 （1-day treatment）, NPF-08 （2-day split dose） and Moviprep（1-day treatment） in people with Patients Who Receive Colonoscopy, run by Nihon Pharmaceutical Co., Ltd at 13 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Patients Who Receive Colonoscopy
What is being tested?: NPF-08 （1-day treatment）, NPF-08 （2-day split dose） and Moviprep（1-day treatment）
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 632 participants
Where: 13 sitesJapan
Study dates: 5 Jan 2019to 19 Jun 2019
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

Patients who have or are suspected to have gastrointestinal obstruction.
Patients who have or are suspected to have intestinal perforation.
Patients who have or are suspected to have toxic megacolon.
Patients who have or are suspected to have gastric evacuation disorder (gastroparesis).
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).
Patients with vomiting reflex or in whom accidental ingestion may occur.

Show all 21Show fewer

Patients with a history of gastrointestinal surgery (except for appendicectomy).
Patients who were decided as glucose-6-phosphate dehydrogenase (G-6-PD) deficiency.
Patients with renal impairment (urea nitrogen: 25mg/dL or more, or creatinine: 2mg/dL or more)
Patients with hepatic dysfunction (total bilirubin: 3.0mg/dL or more, ALT: 100IU/L or more or AST: 100IU/L or more)
Patients who have undergone or require therapy due to high-grade cardiac disease (including angina pectoris or myocardial infarction)
Patients with high risk of arrhythmia (with a history or complications of QT prolongation, myocardial infarction, angina pectoris, cardiac failure or cardiomyopathy)
Patients with dehydration.
Patients who were diagnosed with active inflammatory bowel disease at screening period.
Inpatients due to the reasons other than endoscopy large bowel.
Patients who have undergone nutritional control using total parenteral nutrition or enteral nutrition.
Women who are or may be pregnant, lactating or wish to become pregnant during the trial period.
Patients with a history or high-risk of seizure.
Patients with a history of shock or hypersensitivity for the active ingredient of the investigational product.
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.
Patients in whom Investigator/Sub-Investigator decided not to be eligible for this trial.

Trial locations and contacts

13 sites in 1 country.

City, postcode or hospital

13 sites in 1 country

Japan13 sites

NPF-08 Trial Site 12
Abiko, Chiba
NPF-08 Trial Site 2
Chuo-Ku, Tokyo
NPF-08 Trial Site 8
Hiroshima
NPF-08 Trial Site 11
Kashiwa, Chiba
NPF-08 Trial Site 10
Kawasaki, Kanagawa
NPF-08 Trial Site 13
Kouchi
NPF-08 Trial Site 1
Maebashi, Gunnma
NPF-08 Trial Site 3
Minato-Ku, Tokyo
NPF-08 Trial Site 6
Osaka
NPF-08 Trial Site 7
Osaka
NPF-08 Trial Site 4
Shinjuku-Ku, Tokyo
NPF-08 Trial Site 5
Yokohama, Kanagawa
NPF-08 Trial Site 9
Yokohama, Kanagawa

Other trials in Japan

About this study

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

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.

Conditions: Patients Who Receive Colonoscopy
Being tested: NPF-08 （1-day treatment）, NPF-08 （2-day split dose）, Moviprep（1-day treatment）

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NPF-08 （1-day treatment）Drug
NPF-08 will be administered on the day of colonoscopy.
NPF-08 （2-day split dose）Drug
NPF-08 will be administered at 2 days divided into the day before and on the day of colonoscopy.
Moviprep（1-day treatment）Drug
Moviprep will be administered on the day of colonoscopy.

Study groups in NCT03794310
Study group	Role	What they receive
NPF-08 （1-day treatment）	Experimental	Not described Receives: Drug: NPF-08 （1-day treatment）
NPF-08 （2-day split dose）	Experimental	Not described Receives: Drug: NPF-08 （2-day split dose）
Moviprep（1-day treatment）	Active comparator	Not described Receives: Drug: Moviprep（1-day treatment）

What is being measured

The primary outcome is the main question the study is designed to answer.

The efficacy rate of overall intestinal cleansing effect evaluated by Endoscopic Image Evaluation Committee (EIEC).
The bowel cleanliness at 5 colon segments (appendix/ascending colon, transverse colon, descending colon, sigmoid colon, rectum) will be evaluated. If the bowel cleanliness is "1" or "2" at all colon segments, it is judged as effective. Other cases will be judged as not effective.
1. Almost no residue is found in the intestinal tract enabling good observation
2. Residue remains but does not interfere the observation
3. Residue interferes the observation
4. A lot of residue makes unable to observe
5. Unable to evaluate
Measured: 1day

Secondary outcomes (8)

The efficacy rate of overall intestinal cleansing effect evaluated by colonoscopists
The bowel cleanliness at 5 colon segments (appendix/ascending colon, transverse colon, descending colon, sigmoid colon, rectum) will be evaluated. If the bowel cleanliness is "1" or "2" at all colon segments, it is judged as effective. Other cases will be judged as not effective.
1. Almost no residue is found in the intestinal tract enabling good observation
2. Residue remains but does not interfere the observation
3. Residue interferes the observation
4. A lot of residue makes unable to observe
5. Unable to evaluate
Measured: 1day
Colon cleansing effect by site
The bowel cleanliness at 5 colon segments (appendix/ascending colon, transverse colon, descending colon, sigmoid colon, rectum) will be evaluated.
1. Almost no residue is found in the intestinal tract enabling good observation
2. Residue remains but does not interfere the observation
3. Residue interferes the observation
4. A lot of residue makes unable to observe
5. Unable to evaluate
Measured: 1day
Evaluation based on Ottawa Bowel Preparation Scale
Endoscopic operators will evaluate for colon cleansing degree at the bowel 5 sites (cecum/ascending colon, transverse colon, descending colon, sigmoid colon and rectum) based on the following 5 degrees (0-4) and the amount of fluid at overall bowel based on the following 3 degrees (0-2), and will also evaluate the status during operating normal endoscopy. Lower score indicates better cleansing effect.
Measured: 1day
Time from the initiation of dosing the investigational product to the completion of colon cleansing on the day of endoscopy.
Clinical cooperator will determine the duration from the initiation of administration of the investigational product on the day of colonoscopy to the time when the cooperator will decide that colon cleansing will be completed as the discharged liquid will become transparent.
Measured: 1day
Dosage of the investigational product.
Clinical cooperator will determine the dosage of the investigational product from the initiation of administration of the investigational product to the time when the cooperator will decide that colon cleansing will be completed as the discharged liquid will become transparent.
Measured: 1day or 2day
Concordance rate of intestinal cleansing effect between by EIEC members.
For the evaluations of intestinal cleansing degree conducted at the primary endpoint, the concordance rate between by 3 members of EIEC will be investigated.
Measured: 1day
Concordance rate between the intestinal cleansing effect evaluated by EIEC and the endoscopic operators.
For the evaluations of intestinal cleansing degree conducted at the primary endpoint and secondary endpoints, the concordance rate between the evaluations by EIEC and that by the endoscopic operators will be investigated.
Measured: 1day
Acceptability by subjects
Subjects will evaluate the following points by selecting among 10 levels (circling the applicable figure): Taste of the investigational product; amount of the investigational product; amount of water you will drink after taking the investigational product; and acceptability of the pre-medication (will you choose the pre-medication at the next time?).
Measured: 1day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Jan 201919 Jun 2019

First posted7 Jan 2019
Study start5 Jan 2019
Primary completion19 Jun 2019
Study completion19 Jun 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Patients Who Receive ColonoscopyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 632 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03794310
Sponsor's protocol ID: NPF-08-01/C-01
Status last verified: Aug 2019
First submitted: 4 Jan 2019
Last updated: 29 Nov 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Saito Y, Oka S, Tamai N, Kudo T, Kuniyoshi N, Shirakura T, Omae Y, Hamahata Y, Arai T, Tanaka S, Uedo N, Shimizu S, Fukuzawa M, Uraoka T, Ichinose S, Ogata H, Kobayashi K, Saito S, Tajiri H. Efficacy and safety of oral sulfate solution for bowel preparation in Japanese patients undergoing colonoscopy: Noninferiority-based, randomized, controlled study. Dig Endosc. 2021 Nov;33(7):1131-1138. doi: 10.1111/den.13930. Epub 2021 Mar 9.
PubMed 33476415

Study at a glance

From the registry record, last updated by the sponsor on 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III Comparison Study of NPF-08 in Patients Who Receive Colonoscopy
ClinicalTrials.gov ID: NCT03794310
Acronym / sponsor ID: NPF-08-01/C-01
Conditions: Patients Who Receive Colonoscopy
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 632 participants (actual)
Lead sponsor: Nihon Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
Study start: 5 Jan 2019 (actual)
Primary completion: 19 Jun 2019 (actual)
Study completion: 19 Jun 2019 (actual)
First posted: 7 Jan 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
NPF-08 （1-day treatment）	Experimental	Drug: NPF-08 （1-day treatment）
NPF-08 （2-day split dose）	Experimental	Drug: NPF-08 （2-day split dose）
Moviprep（1-day treatment）	Active comparator	Drug: Moviprep（1-day treatment）

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (21 listed)

Patients who have or are suspected to have gastrointestinal obstruction.
Patients who have or are suspected to have intestinal perforation.
Patients who have or are suspected to have toxic megacolon.
Patients who have or are suspected to have gastric evacuation disorder (gastroparesis).
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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
NPF-08 （1-day treatment）NPF-08 will be administered on the day of colonoscopy.	Drug	NPF-08 （1-day treatment）
NPF-08 （2-day split dose）NPF-08 will be administered at 2 days divided into the day before and on the day of colonoscopy.	Drug	NPF-08 （2-day split dose）
Moviprep（1-day treatment）Moviprep will be administered on the day of colonoscopy.	Drug	Moviprep（1-day treatment）

Primary outcome

The efficacy rate of overall intestinal cleansing effect evaluated by Endoscopic Image Evaluation Committee (EIEC).
Time frame: 1day
The bowel cleanliness at 5 colon segments (appendix/ascending colon, transverse colon, descending colon, sigmoid colon, rectum) will be evaluated. If the bowel cleanliness is "1" or "2" at all colon segments, it is judged as effective. Other cases will be judged as not effective. 1. Almost no residue is found in the intestinal tract enabling good observation 2. Residue remains but does not interfere the observation 3. Residue interferes the observation 4. A lot of residue makes unable to observe 5. Unable to evaluate

8 secondary outcomes

The efficacy rate of overall intestinal cleansing effect evaluated by colonoscopists
Time frame: 1day
Colon cleansing effect by site
Time frame: 1day
Evaluation based on Ottawa Bowel Preparation Scale
Time frame: 1day
Time from the initiation of dosing the investigational product to the completion of colon cleansing on the day of endoscopy.
Time frame: 1day
Dosage of the investigational product.
Time frame: 1day or 2day
Concordance rate of intestinal cleansing effect between by EIEC members.
Time frame: 1day
Concordance rate between the intestinal cleansing effect evaluated by EIEC and the endoscopic operators.
Time frame: 1day
Acceptability by subjects
Time frame: 1day

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2022.
Derived from this study: PubMed 33476415Saito Y, Oka S, Tamai N, Kudo T, Kuniyoshi N, Shirakura T, Omae Y, Hamahata Y, Arai T, Tanaka S, Uedo N, Shimizu S, Fukuzawa M, Uraoka T, Ichinose S, Ogata H, Kobayashi K, Saito S, Tajiri H. Efficacy and safety of oral sulfate solution for bowel preparation in Japanese patients undergoing colonoscopy: Noninferiority-based, randomized, controlled study. Dig Endosc. 2021 Nov;33(7):1131-1138. doi: 10.1111/den.13930. Epub 2021 Mar 9.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Hisatsugu Asada study chair

Nihon Pharmaceutical Co., Ltd

13 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The efficacy rate of overall intestinal cleansing effect evaluated by Endoscopic Image Evaluation Committee (EIEC). (time frame: 1day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03794310, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2022.