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ColonoscopyPhase 3NCT06062030

Efficacy and Safety of DWJ1609 for Bowel Cleansing Before Colonoscopy;

A Phase 3 study testing DWJ1609 and DWC202304 in people with Colonoscopy, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.

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

Phase of Development : III Sponsor : DAEWOONG PHARMACEUTICAL Study Sites and Principal Investigator : Dong ll Park M.D. Ph.D , Gastroenterology Kangbuk Samsung Hospital and other 6 study sites Study Period : From the protocol approval date (institutional review board, IRB) 24 Months Investigational product … Read more about this study

Who is it for?
Ages 19 years and olderHealthy volunteers can take part
Conditions the study is for
Colonoscopy
What is being tested?
DWJ1609 and DWC202304
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
215 participants
Where
1 siteSouth Korea
Study dates
8 Mar 2024to 28 Jun 2024
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 19 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Adult men and women 19 years of age or older as of the date of consent in writing
  • a prospective colonoscopy patient
  • 19 kg/㎡ ≤ BMI < 30 kg/㎡
  • A person who voluntarily agrees to participate in this clinical trial and signs a written agreement Abbreviation: BMI = body mass index

Who cannot join

  • A person who undergoes colonoscopy for the following therapeutic purposes (1) balloon dilatation of the stenosis area (2) non-toxic giant colon or decompression of the S-phase colitis (sigmoid volvulus) (3) Removal of foreign substances (4) Vascular dysplasia, ulcer, tumor and treatment of bleeding after polypectomy (5) Treatment for stenosis or tumor bleeding (palliative treatment)
  • A person whose past history has been confirmed during a screening visit (1) Severe heart disease (insecurity angina, acute myocardial infarction, acute heart failure, cardiomyopathy, etc.) or acute respiratory failure within 24 weeks prior to screening (2) Epilepsy or seizures within 96 weeks prior to screening (3) Clinically significant intestinal surgical history regardless of duration (e.g., colon premature surgery, colon resection, etc.)
  • However, appendectomy and hemorrhoids are excluded
  • A person who has been identified or suspected of the following comorbidities during a screening visit (1) active intestinal hemorrhage (2) gastrointestinal obstruction (intestinal obstruction, gastrointestinal obstruction, etc.), gastrointestinal perforation, gastric discharge disorder (gastrointestinal paralysis, gastric congestion, etc.) (3) Inflammatory bowel disease (ulcerative colitis, Crohn's disease, toxic colitis, toxic colitis, etc.) (4) Gastrointestinal ulcers, colorectal mucosal ulcers, ischemic colitis (5) an acute abdominal condition requiring surgery (6) A person who has been identified with the following major cardiovascular diseases
  • ① congestive heart failure
  • ② NYHA functional classification III or IV
Show all 17Show fewer
  • ③ Clinically significant arrhythmia identified by ECG, QTcFb delay (Male > 450 msec, Female > 470 msec) etc.
  • QTc interval corrected by Fridericia's formula (7) Despite adequate medication, uncontrolled hypertension (SBP > 170 mmHg and DBP > 100 mmHg) (8) Diabetes undergoing insulin treatment or in need of insulin treatment (9) Clinically significant electrolyte abnormalities (sodium, potassium, calcium, magnesium, chloride, bicarbonate, phosphate etc.) (10) Those who are at risk of dehydration (transverse fusion, ascites, etc.) (11) Severe renal impairment (eGFRc < 30 mL/min/1.73m2) c. MDRD-eGFR (mL/min/1.73m2) = 186 × (serum creatinine concentration)-1.154 × (age)-0.203 (× 0.742, Female) (12) Child-Pugh class B or C (13) ALT or AST > three times the normal upper limit of the trachea (14) Severe nausea or vomiting that makes it difficult to participate in clinical trials (15) Active infection or high fever above 38℃ (except acute upper respiratory tract infection or local skin infection) (16) Active hepatitis B or C d. Defined as HBsAg positive during screening e. Defined as HCV Ab positive during screening (17) Test results of HIV antibodies and antibody test results
  • A person who is administering the following drugs during a screening visit or is expected to be administered by the time of completion of a colonoscopy (Day 2; Visit 2) (1) Constipation patients who are regularly administered laxatives or gastrointestinal motility promoters within 12 weeks prior to screening (e.g., two to three times a week or more) (2) Administration of laxatives, enema, simethicone, 5HT4 receptor agonist, iron preparation, opioid excluding clinical trial drugs within 7 days of clinical trial drug administration (Day 1)
  • A person who is hypersensitive to the ingredients of a clinical trial drug
  • a pregnant woman or a lactating woman
  • Fertility women and men who have a pregnancy plan or do not agree to perform appropriate contraception during the clinical trial. Appropriate contraception in this trial is as follows
  • hormonal contraceptive
  • implantation of intrauterine device or intrauterine system
  • Infertility procedures/surgery (e.g., bilateral ovarian ligation, vasectomy)
  • A person who has participated in another clinical trial/medical device clinical trial within 4 weeks of screening and has received/treated clinical trial medication/medical device
  • For other reasons, the tester determines that he/she is unfit to be tested for this clinical trial (e.g., clinically significant blood coagulation disorder, mental illness, dementia, drug or alcohol abuse history, oral administration of clinical trial drugs)

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Kangbuk Samsung Hospital

    Seoul, Korea

Other trials in South Korea

About this study

Official title: Efficacy and Safety of DWJ1609 for Bowel Cleansing Before Colonoscopy; a Prospective, Randomized, Single-blinded (Investigator), Parallel, Multi-center, Active-control, Non-inferiority, Phase 3 Clinical Trial

Phase of Development : III

Sponsor : DAEWOONG PHARMACEUTICAL

Read more

Study Sites and Principal Investigator : Dong ll Park M.D. Ph.D , Gastroenterology Kangbuk Samsung Hospital and other 6 study sites

Study Period : From the protocol approval date (institutional review board, IRB) 24 Months

Investigational product :

Investigational Products DWJ1609 (sodium sulfate potassium sulfate, Magnesium Sulfate Anhydrous , simethicone, sodium picosulphate)

Control Products DWC202304 (sodium sulfate potassium sulfate, Magnesium Sulfate Anhydrous , simethicone)

Target Diseases : A person who needs treatment before colonoscopy (X-ray, endoscopy)

Number of Subjects : 214 Subjects in total (85 subjects per group, 2 groups in total, considering a 20% dropout rate)

Read the detailed description

Study Methodology :

Test subjects evaluated as suitable for participation in clinical trials are randomly assigned at a 1:1 ratio to the test group (DWJ1609) and the control group (DWC202304), and clinical trial drugs are distributed for each administration group.

Subjects take the distributed clinical trial drugs as split-dose in the early evening of the day before colonoscopy (Day 1) and in the morning of the day of examination (Day 2) Test subjects visit the clinical trial institution after completing all clinical trial drugs at least 2 hours before colonoscopy (Visit 2).

All test subjects undergo colonoscopy in the morning, and the tester takes an image of all colonoscopy processes according to a separate manual.

For safety evaluation, subjects will conduct a phone visit 2 days after colonoscopy (±1 day) (Visit 3) and a regular visit 7 days after (±1 day) (Visit 4). If additional confirmation is required in the electrocardiogram or laboratory test results at the discretion of the tester, a follow-up visit can be conducted after 28 days (±2 days) (Visit 5).

I

Conditions
Colonoscopy
Being tested
DWJ1609, DWC202304
Keywords
HCS, Bowel Cleansing

What participants receive

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

  • DWJ1609Drug

    Drug of test group

  • DWC202304Drug

    Also called Orafang Tab

    Drug of control group

Study groups in NCT06062030
Study groupRoleWhat they receive
test groupExperimentalInvestigational Products (DWJ1609) Number of tablets: 20 tablets in total Drinking water: 2,550 mL in total The day before the colonoscopy [Day 1] ▶ Common: Eat a light breakfast the day before the examination, or take only clear fluids. Take 10 tablets of DWJ1609 with 425 mL of water in the early evening (18:00-20:00) the day before the test, followed by 2 more doses of 425 mL of water for 1 hour (takes a total of 1,275 mL of water). On the day of colonoscopy [Day 2] ▶ Common: On the day of the examination, only clear liquids should be taken before the examination. Complete the clinical trial medication and additional water intake at least 2 hours prior to the test or at the time indicated by the tester In the evening before the test, take 10 additional DWJ1609 tablets with 425 mL of water in the morning (04:00~08:00), 10 to 12 hours after taking DWJ1609, followed by 2 more doses of 425 mL of water for 1 hour (Total 1,275 mL of water).
Receives: Drug: DWJ1609
control groupActive comparatorControl Products (DWC202304) Number of tablets: 28 tablets in total Drinking water: 2,550 mL in total The day before the colonoscopy [Day 1] Take 14 tablets of DWC202304 with 425 mL of water in the early evening (18:00 to 20:00) the day before the test, followed by 2 more doses of 425 mL of water for 1 hour (takes a total of 1,275 mL of water). On the day of colonoscopy [Day 2] ▶ Common: On the day of the examination, only clear liquids should be taken before the examination. Complete the clinical trial medication and additional water intake at least 2 hours prior to the test or at the time indicated by the tester In the evening before the test, take 14 additional DWC202304 tablets with 425 mL of water in the morning of the test (04:00~08:00), 10 to 12 hours after taking DWC202304, and then take 425 mL of water twice for 1 hour (total 1,275 mL of water).
Receives: Drug: DWC202304

What is being measured

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

  1. The successful cleaning rate of the Harefield Cleansing Scale (HCS) phase rated as 'success'

    Evaluate the overall cleanliness in four steps according to the results of each of the five colon sections Grade A: 3 or 4 points for all colon sections Grade B: One or more sections with a score of 2 Grade C: One or more sections with a score of 1 Grade D: One or more sections with a score of 0

    ※ If the overall colon cleanliness evaluation result is A grade, it is evaluated as successful 'failure (sealing success)' and C grade or D 'failure (sealing failure).

    Measured: from the beginning to the end of colonoscopy (Baseline)

Secondary outcomes (12)

  1. Percentage of test subjects whose HCS cleanliness was evaluated as 'success'

    Evaluate the overall cleanliness in four steps according to the results of each of the five colon sections.

    Grade A: 3 or 4 points for all colon sections Grade B: One or more sections with a score of 2 Grade C: One or more sections with a score of 1 Grade D: One or more sections with a score of 0

    ※ If the overall colon cleanliness evaluation result is A grade, it is evaluated as successful 'failure (sealing success)' and C grade or D 'failure (sealing failure).

    Measured: from the beginning to the end of colonoscopy(Baseline)

  2. Overall cleanliness ratio on HCS (overall cleansing rate)

    Percentage of test subjects rated as grade A, B, C, and D on the HCS

    Measured: from the beginning to the end of colonoscopy(Baseline)

  3. Average score for each 5 compartments on the HCS (mean HCS score)

    Assessment of crystallinity by five colon sections (rector, sigmoid colon, descending colon, lateral colon, ascending colon)

    Measured: from the beginning to the end of colonoscopy(Baseline)

  4. Percentage of test subjects with residual air bubbles on the bubble score

    Assess the degree of gas removal (bubble degree) by five colon sections (rector, sigmoid colon, descending colon, lateral colon, ascending colon)

    Grade 0 No or minimal scattered bubbbles Grade 1 Bubbles covering at least half the luminal diameter Grade 2 Bubbles covering the circumference of the lumen Grade 3 Bubbles filling the entire lumen

    Measured: from the beginning to the end of colonoscopy(Baseline)

  5. Percentage of test subjects found to have polyps or adenoma (detection of polyp or adenoma)

    The examiner checks whether polyps or adenomas are found through colonoscopy, and the test subjects with one or more polyps/adenomas are defined as "detection."

    Measured: from the beginning to the end of colonoscopy(Baseline)

  6. Percentage of test subjects whose endoscopy has reached the appendix (cecal intubation rate)

    The cecal intubation is defined as passing the tip of a colonoscopy to the proximal part of the ileocecal valve so that the entire cecal caput is visible, including the inner wall of the cecal valve between the ileocecal valve and the cecal entrance

    Measured: from the beginning to the end of colonoscopy(Baseline)

  7. Total colonoscopy time

    The total colonoscopy time is the sum of colonoscopy insertion time and recovery time

    Measured: from the beginning to the end of colonoscopy(Baseline)

  8. Percentage of test subjects in taste category

    Subsequently, the intention to use the same colon cleaner during colonoscopy is evaluated as "yes" and "no."

    Measured: End of colonoscopy(Baseline)

  9. Percentage of subjects tested by compliance with administration of clinical trial drugs

    1. Percentage of test subjects administered 100%
    2. Percentage of test subjects administered 75% or more and less than 100%
    3. Percentage of test subjects administered less than 75%

    Measured: End of colonoscopy(Baseline)

  10. IP medication satisfaction

    (1) Average score of difficulty when taken

    Measured: from the beginning to the end of colonoscopy(Baseline)

  11. IP medication satisfaction

    (2) Percentage of test subjects in category of difficulty in taking

    Measured: from the beginning to the end of colonoscopy(Baseline)

  12. IP medication satisfaction

    (3) an average score of taste

    Measured: from the beginning to the end of colonoscopy(Baseline)

Timeline

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

  1. First posted2 Oct 2023
  2. Study start8 Mar 2024
  3. Primary completion3 Jun 2024
  4. Study completion28 Jun 2024

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Care provider
Enrolment
215 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06062030
Sponsor's protocol ID
DWJ1609301
Status last verified
Dec 2024
First submitted
29 Aug 2023
Last updated
20 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing DWJ1609 and DWC202304 in people with Colonoscopy, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.

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 4 inclusion and 17 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 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. 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 successful cleaning rate of the Harefield Cleansing Scale (HCS) phase rated as 'success' (time frame: from the beginning to the end of colonoscopy (Baseline)). 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 NCT06062030.

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 20 Dec 2024.

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