Anterior Resection SyndromeEarly Phase 1NCT02869984
Clinical Trial Assessing 5-HT3 Receptor Antagonist (Ramosetron) for the Treatment of Anterior Resection Syndrome
A Early Phase 1 study testing Ramosetron in people with Anterior Resection Syndrome, run by Seoul National University Hospital.
Trial summary
Poor functional outcomes has been reported inevitably, and up to 90% of the patients have experienced bowel habit changes after sphincter-saving surgery for rectal cancer. But, currently there has been no specific treatment for ARS and symptom based empirical management is tried Recently, 5-HT3 receptor antagonists… Read more about this study
- Who is it for?
- Ages 19 to 80 years, men only
- Conditions the study is for
- Anterior Resection Syndrome
- What is being tested?
- Ramosetron
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to Oct 2018
- Phase
- Early Phase 1
- 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 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patients who undergo sphincter saving surgery for rectal cancer
Who cannot join
- recurred rectal cancer
- rectal cancer with distant metastasis
- permanent stoma formation
- postoperative concurrent chemoradiotherapy
- uncontrolled medical disease
- inflammatory bowel disease
Show all 9Show fewer
- uncontrolled constipation
- preoperative incontinence (LARS score, more than 20)
- allergic to intervention drug
Trial locations and contacts
No sites are listed yet.
About this study
Poor functional outcomes has been reported inevitably, and up to 90% of the patients have experienced bowel habit changes after sphincter-saving surgery for rectal cancer. But, currently there has been no specific treatment for ARS and symptom based empirical management is tried Recently, 5-HT3 receptor antagonists can be used for treatment of IBS-D, and has been revealed to be slowing the bowel movement and improving stool consistency and urgency.
We performed the clinical trial with using ramosetron (Irribow®) for the treatment of ARS
- Conditions
- Anterior Resection Syndrome
- Being tested
- Ramosetron
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RamosetronDrug
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | ramosetron treatment for 4 weeks from 1mo after anterior resection for rectal cancer Receives: Drug: Ramosetron |
| Control | No intervention | No treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
low anterior resection syndrome score
questionnaire with comparison of frequency or urgency
Measured: 4 weeks
Secondary outcomes (1)
Quality of Life score
EORTC QLQ C30 (Korean version, validated)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionOct 2018 (estimated)
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 Anterior Resection SyndromeStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Dong-A ST
- Responsible party
- Principal investigator, Kyu Joo Park, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02869984
- Sponsor's protocol ID
- 1604-095-755
- Status last verified
- Aug 2016
- First submitted
- 10 Aug 2016
- Last updated
- 17 Aug 2016
- Results posted
- No
Publications
Ryoo SB, Park JW, Lee DW, Lee MA, Kwon YH, Kim MJ, Moon SH, Jeong SY, Park KJ. Anterior resection syndrome: a randomized clinical trial of a 5-HT3 receptor antagonist (ramosetron) in male patients with rectal cancer. Br J Surg. 2021 Jun 22;108(6):644-651. doi: 10.1093/bjs/znab071.
PubMed 33982068
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial Assessing 5-HT3 Receptor Antagonist (Ramosetron) for the Treatment of Anterior Resection Syndrome
- ClinicalTrials.gov ID
- NCT02869984
- Acronym / sponsor ID
- 1604-095-755
- Conditions
- Anterior Resection Syndrome
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Dong-A ST
- Study start
- Aug 2016
- Primary completion
- Oct 2018 (estimated)
- First posted
- 17 Aug 2016 (estimated)
- 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.
Poor functional outcomes has been reported inevitably, and up to 90% of the patients have experienced bowel habit changes after sphincter-saving surgery for rectal cancer. But, currently there has been no specific treatment for ARS and symptom based empirical management is tried Recently, 5-HT3 receptor antagonists can be used for treatment of IBS-D, and has been revealed to be slowing the bowel movement and improving stool consistency and urgency.
We performed the clinical trial with using ramosetron (Irribow®) for the treatment of ARS
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Ramosetronramosetron treatment for 4 weeks from 1mo after anterior resection for rectal cancer |
| Control | No intervention | –No treatment |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The patients who undergo sphincter saving surgery for rectal cancer
Key exclusion criteria (9 listed)
- recurred rectal cancer
- rectal cancer with distant metastasis
- permanent stoma formation
- postoperative concurrent chemoradiotherapy
- uncontrolled medical disease
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 |
|---|---|---|
| Ramosetron | Drug | Treatment |
Primary outcome
low anterior resection syndrome score
Time frame: 4 weeks
questionnaire with comparison of frequency or urgency
1 secondary outcome
Quality of Life score
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2016.
- Derived from this study: PubMed 33982068Ryoo SB, Park JW, Lee DW, Lee MA, Kwon YH, Kim MJ, Moon SH, Jeong SY, Park KJ. Anterior resection syndrome: a randomized clinical trial of a 5-HT3 receptor antagonist (ramosetron) in male patients with rectal cancer. Br J Surg. 2021 Jun 22;108(6):644-651. doi: 10.1093/bjs/znab071.
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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.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Ramosetron in people with Anterior Resection Syndrome, run by Seoul National University Hospital.
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 1 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 17 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kyu Joo Park, MD, PhD (+82-2-2072-2901, kjparkmd@plaza.snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
low anterior resection syndrome score (time frame: 4 weeks). 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 NCT02869984, 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 17 Aug 2016.