Colitis, UlcerativePhase 2NCT00463151
An Exploratory Study of Rebamipide in Patients With Active Ulcerative Colitis
A Phase 2 study testing rebamipide in people with Colitis, Ulcerative, run by Otsuka Pharmaceutical Co., Ltd. at 5 sites in Japan.
Trial summary
The purpose of this study is to examine the safety and efficacy of rebamipide by once daily intracolonial administration at 0 (placebo), 60, 150, or 300 mg for 6 weeks in patients with active ulcerative colitis, who are being treated with oral aminosalicylic acid (ASA). Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Colitis, Ulcerative
- What is being tested?
- rebamipide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 5 sitesJapan
- Study dates
- Jun 2007to Aug 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with active ulcerative colitis
- Patients having an insufficient response to ASA oral formulation: (1) Patients whose ongoing use of ASA oral formulation from ≥2 weeks prior to the day before registration is fixed at mesalazine ≥2 g/day or salazosulfapyridine 3-6 g/day, (2) Patients with continuous bloody stools from ≥2 weeks prior to the day before registration, (3) Patients whose DAI subscores are ≥2 points for "bloody stools" and ≥2 points for "endoscopic findings"
- Patients shown via colonoscopy to have major lesions between the sigmoid colon and rectum (with lesions not extending beyond the splenic flexure)
- Outpatients
Who cannot join
- Patients who have a history of intestinal resection (other than appendiceal resection)
- Patients who have a complication of malignant tumor
- Female patients who are pregnant, lactating, or possibly pregnant, or who hope to become pregnant during the study period
- Patients who have complications of serious cardiac, hepatic or renal impairment
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Japan5 sites
Study site
Chubu Region
Study site
Chugoku Region
Study site
Hokkaido Region
Study site
Kinki Region
Study site
Kyushu Region
About this study
The purpose of this study is to examine the safety and efficacy of rebamipide by once daily intracolonial administration at 0 (placebo), 60, 150, or 300 mg for 6 weeks in patients with active ulcerative colitis, who are being treated with oral aminosalicylic acid (ASA).
- Conditions
- Colitis, Ulcerative
- Being tested
- rebamipide
- Keywords
- Rebamipide, Enema, Ulcerative Colitis
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rebamipideDrug
0, 60, 150, 300mg of rebamipide per day for 6 weeks into colon
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | 0mg rebamipide Receives: Drug: rebamipide |
| 2 | Experimental | 60mg rebamipide Receives: Drug: rebamipide |
| 3 | Experimental | 150mg rebamipide Receives: Drug: rebamipide |
| 4 | Experimental | 300mg rebamipide Receives: Drug: rebamipide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Improvement Rate (Number of Subjects Showing Clinical Improvement/Number of Subjects Evaluated x 100)
Definition of clinical improvement: a decrease of Disease Activity Index [DAI] score for "rectal bleeding" to either 0 or 1 point and a decrease of ≥1 point in the DAI score for "findings on endoscopy" from the baseline
Measured: Week 6
Secondary outcomes (4)
Clinical Remission (Number of Subjects Showing Remission/Number of Subjects Evaluated x 100)
Definition of remission: a decrease of the total DAI scores for "rectal bleeding" and "findings on endoscopy" to 0 points
Measured: Week 6
Mean Change From Baseline in Total DAI Score
DAI measures disease activity through assessment of 4 items/subscales: stool frequency, rectal bleeding, findings on endoscopy, and physician's global assessment. Each item of the score is assessed on a 4-point scale from 0 to 3; the total score ranges from 0 to 12 with a higher score representing greater severity. A negative change in mean score indicates improvement.
Measured: Baseline and Week 6
Percentage of Subjects Showing Improvement in Each DAI Subscore
DAI measures disease activity through assessment of 4 items/subscales: stool frequency, rectal bleeding, findings on endoscopy, and physician's global assessment. Each item of the score is assessed on a 4-point scale from 0 to 3 with a higher score representing greater severity. A negative change from baseline indicates improvement.
Measured: Baseline and week 6
Mean Change From Baseline in Total Endoscopic Index (EI) Score
The index consisted of 4 subscales: granulation scattering reflected light, vascular pattern, vulnerability of mucosa, and mucosal damage. Each subscale was scored on a scale of 0 to 4 and the total score (the sum of all 4 subscores) ranges from 0 to 12, higher scores indicate more severe disease.
Measured: Baseline and Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2007 (estimated)
- Study startJun 2007
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Colitis, UlcerativeStudies of the same condition, open and under way.
- More trials run by Otsuka 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Katsuhisa Saito, Study director, Division of New Product Evaluation and Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00463151
- Sponsor's protocol ID
- 037-06-001
- Other IDs
- JapicCTI-070399
- Status last verified
- Jun 2021
- First submitted
- 19 Apr 2007
- Last updated
- 20 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of Rebamipide in Patients With Active Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT00463151
- Acronym / sponsor ID
- 037-06-001
- Conditions
- Colitis, Ulcerative
- Keywords
- Rebamipide, Enema, Ulcerative Colitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 20 Apr 2007 (estimated)
- Results
- Posted 20 Jul 2021
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 is to examine the safety and efficacy of rebamipide by once daily intracolonial administration at 0 (placebo), 60, 150, or 300 mg for 6 weeks in patients with active ulcerative colitis, who are being treated with oral aminosalicylic acid (ASA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: rebamipide0mg rebamipide |
| 2 | Experimental | Drug: rebamipide60mg rebamipide |
| 3 | Experimental | Drug: rebamipide150mg rebamipide |
| 4 | Experimental | Drug: rebamipide300mg rebamipide |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with active ulcerative colitis
- Patients having an insufficient response to ASA oral formulation: (1) Patients whose ongoing use of ASA oral formulation from ≥2 weeks prior to the day before registration is fixed at mesalazine ≥2 g/day or salazosulfapyridine 3-6 g/day, (2) Patients with continuous bloody stools from ≥2 weeks prior to the day before registration, (3) Patients whose DAI subscores are ≥2 points for "bloody stools" and ≥2 points for "endoscopic findings"
- Patients shown via colonoscopy to have major lesions between the sigmoid colon and rectum (with lesions not extending beyond the splenic flexure)
- Outpatients
Key exclusion criteria (4 listed)
- Patients who have a history of intestinal resection (other than appendiceal resection)
- Patients who have a complication of malignant tumor
- Female patients who are pregnant, lactating, or possibly pregnant, or who hope to become pregnant during the study period
- Patients who have complications of serious cardiac, hepatic or renal impairment
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 |
|---|---|---|
| rebamipide0, 60, 150, 300mg of rebamipide per day for 6 weeks into colon | Drug | 1, 2, 3, 4 |
Primary outcome
Clinical Improvement Rate (Number of Subjects Showing Clinical Improvement/Number of Subjects Evaluated x 100)
Time frame: Week 6
Definition of clinical improvement: a decrease of Disease Activity Index [DAI] score for "rectal bleeding" to either 0 or 1 point and a decrease of ≥1 point in the DAI score for "findings on endoscopy" from the baseline
4 secondary outcomes
Clinical Remission (Number of Subjects Showing Remission/Number of Subjects Evaluated x 100)
Time frame: Week 6
Mean Change From Baseline in Total DAI Score
Time frame: Baseline and Week 6
Percentage of Subjects Showing Improvement in Each DAI Subscore
Time frame: Baseline and week 6
Mean Change From Baseline in Total Endoscopic Index (EI) Score
Time frame: Baseline and Week 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Katsuhisa Saito study director
Division of New Product Evaluation and Development
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing rebamipide in people with Colitis, Ulcerative, run by Otsuka Pharmaceutical Co., Ltd. at 5 sites in Japan.
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 4 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 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Clinical Improvement Rate (Number of Subjects Showing Clinical Improvement/Number of Subjects Evaluated x 100) (time frame: Week 6). 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 20 Jul 2021.