A Dose-finding Study of OPC-6535 in Patients With Active Ulcerative Colitis

Colitis, Ulcerative Clinical Trial

Official title:

A Dose-finding Study of OPC-6535 in Patients With Active Ulcerative Colitis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00317356
• Other study ID #: 197-05-002
• Secondary ID: JapicCTI-060216
• Status: Terminated
• Phase: Phase 2
• Start date: May 2006
• Est. completion date: August 2007

Study information

• Verified date: April 2021
• Source: Otsuka Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to examine the safety and efficacy of OPC-6535 (tetomilast) and to determine its optimal dose by once-daily oral administration at 0, 12.5, 25, or 50 mg for 8 weeks in combination with a fixed oral dose of 5-aminosalicylic acid (5-ASA) in patients with active ulcerative colitis.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 43
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients with active ulcerative colitis

• Patients who have been receiving an oral 5-ASA formulation at a fixed regimen and at a fixed dose

• Either inpatient or outpatient

Exclusion Criteria:

• 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 wish to become pregnant during the study period

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer

Intervention

Drug:
• OPC-6535(Tetomilast)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Improvement Rate (Number of Subjects Showing Clinical Improvement/Number of Subjects Evaluated x 100) After 8 Weeks of Study Drug Administration	Definition of clinical improvement: Disease Activity Index (DAI) subscore for rectal bleeding improved to 0 or 1 and DAI subscore for mucosal appearance improved by at least 1 point from baseline	Weeks 4 and 8
Secondary	Remission Rate (Number of Subjects Showing Remission/Number of Subjects Evaluated x 100) After 4 and 8 Weeks of Study Drug Administration	Definition of remission: DAI subscores for both rectal bleeding and mucosal appearance improved to 0	Weeks 4 and 8
Secondary	Mean Change From the Baseline in Total DAI Score After 4 and 8 Weeks of Study Drug Administration	DAI measures disease activity through assessment of 4 items/subscales: stool frequency, rectal bleeding, mucosal appearance at endoscopy, and physician's rating of disease activity. 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.	Baseline, Weeks 4 and 8
Secondary	Mean Change From the Baseline in DAI Subscores After 4 and 8 Weeks of Study Drug Administration	DAI measures disease activity through assessment of 4 items/subscales: stool frequency, rectal bleeding, mucosal appearance at endoscopy, and physician's rating of disease activity. 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 in mean score indicates improvement.	Baseline, Weeks 4 and 8
Secondary	Mean Change From the Baseline in Total Clinical Activity Index (CAI) Score After 2, 4, and 8 Weeks of Study Drug Administration	CAI composed of 7 variables: number of stool weekly, blood in stools (weekly average), investigator's global assessment of symptomatic state, abdominal pain/cramps, temperature due to colitis, extraintestinal manifestations, and laboratory findings. The scores ranging from 0 to 29 points (higher scores meaning more severe disease).	Baseline, Weeks 2, 4 and 8
Secondary	Mean Change From the Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score After 8 Weeks of Study Drug Administration	The IBDQ has been frequently adopted in Japanese and overseas clinical assessments as a scale for evaluating the quality of life (QOL) of subjects with inflammatory bowel disease. The IBDQ score was calculated as the sum of the responses (each ranging from 1 to 7) to all 32 questions that address symptoms as a result of Crohn's disease: bowel symptoms, systemic symptoms, emotional function, and social function. Total IBDQ score ranges from 32 to 224 with a higher score indicating a better QOL.	Baseline and Week 8
Secondary	Mean Change From the Baseline in IBDQ Subscale Scores After 8 Weeks of Study Drug Administration	The IBDQ has been frequently adopted in Japanese and overseas clinical assessments as a scale for evaluating the quality of life (QOL) of subjects with inflammatory bowel disease. The IBDQ includes 32 items, which are divided into four subscales: bowel symptoms, systemic symptoms, emotional function and social function, and each item is scored on a 7-point scale, ranging from 1 (worst) to 7 (best). Total IBDQ score ranges from 32 to 224 with a higher score indicating a better QOL.	Baseline and Week 8
Secondary	Clinical Improvement Rate After 4 Weeks of Study Drug Administration	Definition of clinical improvement: DAI subscore for rectal bleeding improved to 0 or 1 and DAI subscore for mucosal appearance improved by at least 1 point from baseline	Week 4