Irritable Bowel SyndromePhase 4NCT01629212
Comparison of the Efficacy and Safety of Tiropramide and Octylonium in the Treatment of Irritable Bowel Syndrome
A Phase 4 study testing Tiropramide HCl 100mg and Octylonium bromide 20mg in people with Irritable Bowel Syndrome, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial summary
The purpose of this study was to compare the Efficacy and Safety of Tiropramide HCl and Octylonium bromide in the Treatment of Irritable Bowel Syndrome. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Tiropramide HCl 100mg and Octylonium bromide 20mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2011to Feb 2013
- Phase
- Phase 4
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (aged 20-75 years)
- Patients who had been suffered from IBS as defined by Rome III criteria
- Patients who had abdominal pain at least 2 days/week, during the run-in period of 2 weeks
Who cannot join
- Patients with known intolerance to tiropramide or octylonium
- Patients with uncontrolled diabetes, uncontrolled hypertension or thyroid dysfunction
- Patients who had the history of cancer [However, patients with cancer other than gastrointerstinal cancer, who have not recurr within 5 years after treatment were possible for enrollment]
- Patients with hepatic or renal dysfunction
- Patients with lactose intorelance
Trial locations and contacts
1 site in 1 country.
Oh Young Lee, MD contact
South Korea1 site, 1 recruiting
- Recruiting
Han Yang University Hospital
Seoul
Oh Young Lee, leeoy@hanyang.ac.kr
About this study
Official title: Comparative and Analytical Study for Effectiveness and Safety of Tiropramide HCl and Octylonium Bromide in the Treatment of Irritable Bowel Syndrome: Mullticenter, Randomized, Double Blind, Active Controlled Study
The purpose of this study was to compare the Efficacy and Safety of Tiropramide HCl and Octylonium bromide in the Treatment of Irritable Bowel Syndrome.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Tiropramide HCl 100mg, Octylonium bromide 20mg
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tiropramide HCl 100mgDrug
Octylonium bromide 20mgDrug
| Study group | Role | What they receive |
|---|---|---|
| Tiropramide HCl | Experimental | Not described Receives: Drug: Tiropramide HCl 100mg |
| Octylonium bromide | Active comparator | Not described Receives: Drug: Octylonium bromide 20mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of abdominal pain VAS scores from baseline to week 4
Secondary outcomes (2)
Change of abdominal pain VAS scores from baseline to week 2
Change of abdominal discomfort VAS scores from baseline to week 2 and 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2012 (estimated)
- Study startDec 2011
- Primary completionFeb 2013 (estimated)
- Study completionFeb 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Daewoong Pharmaceutical Co. LTD.The 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
- Phase 4
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01629212
- Sponsor's protocol ID
- DW-TRP001
- Status last verified
- Jun 2012
- First submitted
- 21 Jun 2012
- Last updated
- 27 Jun 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative and Analytical Study for Effectiveness and Safety of Tiropramide HCl and Octylonium Bromide in the Treatment of Irritable Bowel Syndrome: Mullticenter, Randomized, Double Blind, Active Controlled Study
- ClinicalTrials.gov ID
- NCT01629212
- Acronym / sponsor ID
- DW-TRP001
- Conditions
- Irritable Bowel Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Feb 2013 (estimated)
- Study completion
- Feb 2013 (estimated)
- First posted
- 27 Jun 2012 (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.
The purpose of this study was to compare the Efficacy and Safety of Tiropramide HCl and Octylonium bromide in the Treatment of Irritable Bowel Syndrome.
Study design
- Primary purpose
- Treatment
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tiropramide HCl | Experimental | Drug: Tiropramide HCl 100mg |
| Octylonium bromide | Active comparator | Drug: Octylonium bromide 20mg |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients (aged 20-75 years)
- Patients who had been suffered from IBS as defined by Rome III criteria
- Patients who had abdominal pain at least 2 days/week, during the run-in period of 2 weeks
Key exclusion criteria (5 listed)
- Patients with known intolerance to tiropramide or octylonium
- Patients with uncontrolled diabetes, uncontrolled hypertension or thyroid dysfunction
- Patients who had the history of cancer [However, patients with cancer other than gastrointerstinal cancer, who have not recurr within 5 years after treatment were possible for enrollment]
- Patients with hepatic or renal dysfunction
- Patients with lactose intorelance
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 |
|---|---|---|
| Tiropramide HCl 100mg | Drug | Tiropramide HCl |
| Octylonium bromide 20mg | Drug | Octylonium bromide |
Primary outcome
Change of abdominal pain VAS scores from baseline to week 4
2 secondary outcomes
Change of abdominal pain VAS scores from baseline to week 2
Change of abdominal discomfort VAS scores from baseline to week 2 and 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2012.
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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.
Oh Young Lee, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tiropramide HCl 100mg and Octylonium bromide 20mg in people with Irritable Bowel Syndrome, 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 3 inclusion and 5 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 27 Jun 2012. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Oh Young Lee, MD (leeoy@hanyang.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of abdominal pain VAS scores from baseline to week 4. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jun 2012.