An Exploratory Study of Rebamipide in Patients With Active Ulcerative Colitis

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00463151

Enrollment

124

Registered

2007-04-20

Start date

2007-06-30

Completion date

2008-08-31

Last updated

2021-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colitis, Ulcerative

Keywords

Rebamipide, Enema, Ulcerative Colitis

Brief 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).

Interventions

DRUGrebamipide

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Healthy volunteers

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

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

Design outcomes

Primary

Measure	Time frame	Description
Clinical Improvement Rate (Number of Subjects Showing Clinical Improvement/Number of Subjects Evaluated x 100)	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

Secondary

Measure	Time frame	Description
Clinical Remission (Number of Subjects Showing Remission/Number of Subjects Evaluated x 100)	Week 6	Definition of remission: a decrease of the total DAI scores for rectal bleeding and findings on endoscopy to 0 points
Mean Change From Baseline in Total DAI Score	Baseline and Week 6	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.
Percentage of Subjects Showing Improvement in Each DAI Subscore	Baseline and week 6	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.
Mean Change From Baseline in Total Endoscopic Index (EI) Score	Baseline and Week 6	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.

Countries

Japan

Participant flow

Participants by arm

Arm	Count
Rebamipide 60 mg Once daily intracolonial administration at a dose of 60 mg for 6 weeks	35
Rebamipide 150 mg Once daily intracolonial administration at a dose of 150 mg for 6 weeks	29
Rebamipide 300 mg Once daily intracolonial administration at a dose of 300 mg for 6 weeks	27
Placebo Once daily intracolonial administration of placebo for 6 weeks	30
Total	121

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003
Overall Study	Adverse Event	0	0	1	0
Overall Study	Lack of Efficacy	2	5	2	5
Overall Study	Protocol Violation	0	0	0	1
Overall Study	Withdrawal by Subject	0	0	0	1

Baseline characteristics

Characteristic	Rebamipide 60 mg	Rebamipide 150 mg	Rebamipide 300 mg	Placebo	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	1 Participants	3 Participants	2 Participants	2 Participants	8 Participants
Age, Categorical Between 18 and 65 years	34 Participants	26 Participants	25 Participants	28 Participants	113 Participants
Region of Enrollment Japan	35 Participants	29 Participants	27 Participants	30 Participants	121 Participants
Sex: Female, Male Female	14 Participants	16 Participants	8 Participants	14 Participants	52 Participants
Sex: Female, Male Male	21 Participants	13 Participants	19 Participants	16 Participants	69 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	0 / 35	0 / 29	0 / 29	0 / 31
other Total, other adverse events	22 / 35	20 / 29	18 / 29	22 / 31
serious Total, serious adverse events	0 / 35	2 / 29	0 / 29	1 / 31

Outcome results

Primary

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