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CompletedNCT00463151Updated Jul 20, 2021Results posted

An Exploratory Study of Rebamipide in Patients With Active Ulcerative Colitis

A Phase 2 interventional study of rebamipide in Colitis, Ulcerative, sponsored by Otsuka Pharmaceutical Co., Ltd.. Completed at 5 sites in Japan. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2021-07-20.

Sponsored by Otsuka Pharmaceutical Co., Ltd. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
124
Allocation
Randomized
Ages
16 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Colitis, Ulcerative

Keywords

  • Rebamipide
  • Enema
  • Ulcerative Colitis
03

In context

Colitis

1,073 studies on the registry are indexed under Colitis; 131 are open to participants now.

This study's enrollment of 124 is above the median of 60 across 771 interventional studies indexed under Colitis.

Browse Colitis studies →

Lead sponsor

Otsuka Pharmaceutical Co., Ltd. is the lead sponsor of 140 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patients with active ulcerative colitis
  2. 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"
  3. Patients shown via colonoscopy to have major lesions between the sigmoid colon and rectum (with lesions not extending beyond the splenic flexure)
  4. Outpatients

Exclusion criteria

Exclusion Criteria:

  1. Patients who have a history of intestinal resection (other than appendiceal resection)
  2. Patients who have a complication of malignant tumor
  3. Female patients who are pregnant, lactating, or possibly pregnant, or who hope to become pregnant during the study period
  4. Patients who have complications of serious cardiac, hepatic or renal impairment
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
124 participants (actual)

Study arms

  • Placebo comparator
    1

    0mg rebamipide

    Drug: rebamipide

  • Experimental
    2

    60mg rebamipide

    Drug: rebamipide

  • Experimental
    3

    150mg rebamipide

    Drug: rebamipide

  • Experimental
    4

    300mg rebamipide

    Drug: rebamipide

Interventions

  • Drugrebamipide

    0, 60, 150, 300mg of rebamipide per day for 6 weeks into colon

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Week 6

Secondary outcomes

  1. 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

    Time frame: Week 6

  2. 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.

    Time frame: Baseline and Week 6

  3. 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.

    Time frame: Baseline and week 6

  4. 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.

    Time frame: Baseline and Week 6

07

Results

Posted Jul 20, 2021

Participant flow

Participant flow — Overall Study
MilestoneRebamipide 60 mgRebamipide 150 mgRebamipide 300 mgPlacebo
Started35292931
Completed33242624
Not completed2537
Withdrew: Adverse event0010
Withdrew: Lack of efficacy2525
Withdrew: Protocol violation0001
Withdrew: Withdrawal by subject0001

Outcome measures

PrimaryClinical 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

Time frame:
Week 6
Reported as:
Number · percentage of participants
Clinical Improvement Rate (Number of Subjects Showing Clinical Improvement/Number of Subjects Evaluated x 100)
percentage of participantsRebamipide 60 mgRebamipide 150 mgRebamipide 300 mgPlacebo
Clinical Improvement Rate (Number of Subjects Showing Clinical Improvement/Number of Subjects Evaluated x 100)31.4 (16.0 to 46.8)24.1 (8.6 to 39.7)44.4 (25.7 to 63.2)30.0 (13.6 to 46.4)
SecondaryClinical 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

Time frame:
Week 6
Reported as:
Number · percentage of participants
Clinical Remission (Number of Subjects Showing Remission/Number of Subjects Evaluated x 100)
percentage of participantsRebamipide 60 mgRebamipide 150 mgRebamipide 300 mgPlacebo
Clinical Remission (Number of Subjects Showing Remission/Number of Subjects Evaluated x 100)2.9 (0.0 to 8.4)0.0 (0.0 to 0.0)18.5 (3.9 to 33.2)3.3 (0.0 to 9.8)
SecondaryMean 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.

Time frame:
Baseline and Week 6
Reported as:
Mean · score on a scale
Mean Change From Baseline in Total DAI Score
score on a scaleRebamipide 60 mgRebamipide 150 mgRebamipide 300 mgPlacebo
Mean Change From Baseline in Total DAI Score-2.5 ± 2.5-1.6 ± 2.6-3.0 ± 3.0-2.0 ± 2.1
SecondaryPercentage 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.

Time frame:
Baseline and week 6
Reported as:
Number · percentage of participants
Percentage of Subjects Showing Improvement in Each DAI Subscore
percentage of participantsRebamipide 60 mgRebamipide 150 mgRebamipide 300 mgPlacebo
Stool frequency48.631.059.310.0
Rectal bleeding65.751.766.763.3
Findings on endoscopy39.426.953.848.1
Physician's global assessment48.631.051.936.70
SecondaryMean 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.

Time frame:
Baseline and Week 6
Reported as:
Mean · score on a scale
Mean Change From Baseline in Total Endoscopic Index (EI) Score
score on a scaleRebamipide 60 mgRebamipide 150 mgRebamipide 300 mgPlacebo
Mean Change From Baseline in Total Endoscopic Index (EI) Score-1.6 ± 2.2-1.2 ± 2.5-2.4 ± 2.9-1.9 ± 2.4

Adverse events

Collected over Treatment-emergent adverse events were collected from Day 1 (start of treatment) up to approximately 10 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Rebamipide 60 mg0/35 (0%)0/35 (0%)22/35 (62.9%)
Rebamipide 150 mg0/29 (0%)2/29 (6.9%)20/29 (69%)
Rebamipide 300 mg0/29 (0%)0/29 (0%)18/29 (62.1%)
Placebo0/31 (0%)1/31 (3.2%)22/31 (71%)
Most frequent serious events
Most frequent serious events
EventRebamipide 60 mgRebamipide 150 mgRebamipide 300 mgPlacebo
Colitis ulcerativeGastrointestinal disorders0/351/290/291/31
Necrotising fasciitisInfections and infestations0/351/290/290/31
Vertigo positionalEar and labyrinth disorders0/351/290/290/31
Most frequent other events
Showing 10 of 84
Most frequent other events
EventRebamipide 60 mgRebamipide 150 mgRebamipide 300 mgPlacebo
Colitis ulcerativeGastrointestinal disorders2/356/291/291/31
NasopharyngitisInfections and infestations4/353/293/294/31
White blood cell count increasedInvestigations3/353/290/294/31
Hepatic function abnormalHepatobiliary disorders1/353/291/291/31
Alanine aminotransferase increasedInvestigations0/350/293/291/31
Eosinophil count increasedInvestigations1/353/290/291/31
HeadacheNervous system disorders3/350/293/290/31
Rectal tenesmusGastrointestinal disorders1/350/290/293/31
Basophil count increasedInvestigations0/352/290/290/31
Blood pressure increasedInvestigations1/352/291/292/31

Baseline characteristics

Full Analysis Set: subjects who received at least one dose of the study drug and for whom postdose efficacy data were obtained

Age, Categorical
Age, Categorical(Participants)Rebamipide 60 mgRebamipide 150 mgRebamipide 300 mgPlaceboTotal
<=18 years00000
Between 18 and 65 years34262528113
>=65 years13228
Sex: Female, Male
Sex: Female, Male(Participants)Rebamipide 60 mgRebamipide 150 mgRebamipide 300 mgPlaceboTotal
Female141681452
Male2113191669
Region of Enrollment
Region of Enrollment(Participants)Rebamipide 60 mgRebamipide 150 mgRebamipide 300 mgPlaceboTotal
Japan35292730121
08

Study locations

5 sites
  • Chubu Region, Japan
  • Chugoku Region, Japan
  • Hokkaido region, Japan
  • Kinki Region, Japan
  • Kyushu Region, Japan
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 20, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00463151
Lead sponsor
Otsuka Pharmaceutical Co., Ltd.
First posted
Apr 20, 2007
Start date
Jun 2007
Primary completion
Aug 2008
Completion
Aug 2008
Results posted
Jul 20, 2021
Last update
Jul 20, 2021

Study contacts

Katsuhisa Saito
study director · Division of New Product Evaluation and Development

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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