A Dose-finding Study of OPC-6535 in Patients With Active Crohn's Disease

Phase 2

Terminated

• Conditions: Crohn Disease

• Registration Number: NCT00317369
• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-04-21
• Study First Submitted QC: 2006-04-21
• Study First Posted: 2006-04-24
• Study Start: 2006-05
• Primary Completion: 2007-07-11
• Study Completion: 2007-08
• Status Verified: 2021-01
• Results First Submitted: 2021-01-05
• Results First Submitted QC: 2021-01-26
• Last Update Submitted: 2021-01-26
• Results First Posted: 2021-02-15
• Last Update Posted: 2021-02-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

• Patients with active Crohn's disease
• Patients who have a primary lesion in either the small intestine or the large intestine
• Patients who have been receiving an oral 5-ASA formulation at a fixed regimen and at a fixed dose
• Patients who have either never received enteral nutrition or have been receiving enteral nutrition at a fixed intake of 1200 kcal/day or less
• Either inpatient or outpatient

Exclusion Criteria

• Patients who have an external fistula (including anal fistula) in which persistent drainage is observed (and who require treatment with antibiotics or synthetic antibacterial agents)
• Patients with short bowel syndrome (and who require intravenous nutritional support due to insufficient intestinal nutrient uptake)
• Patients with an artificial anus
• Patients who have a complication of serious infectious disease (intra-abdominal abscess, etc.)
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Clinical Improvement Rate (Number of Subjects Showing Clinical Improvement/Number of Subjects Evaluated x 100) After 8 Weeks of Study Drug Administration	Week 8	Definition of clinical improvement: Total Crohn's Disease Activity Index (CDAI) score improved by at least 70 points from the baseline score or to below 150 (CDAI \< 150: Remission, CDAI \> 450: severe disease)

Secondary Outcome Measures

Name	Time	Method
Remission Rate (Number of Patients Showing Remission/Number of Patients Evaluated x 100) After 2, 4, and 8 Weeks of Study Drug Administration	Week 2, Week 4，Week 8	Definition of remission: Total CDAI score improved to below 150
Mean Change From Baseline in Total CDAI Score After 2, 4, and 8 Weeks of Study Drug Administration	Baseline, Weeks 2, 4, and 8	CDAI scores range approximately from 0 to 600, higher scores indicating greater disease activity (CDAI \< 150: Remission, CDAI \> 450: Very severe). A negative change in mean score indicates improvement.
Clinical Improvement Rate After 2 and 4 Weeks of Study Drug Administration	Week 2, Week 4	Definition of clinical improvement: Total CDAI score improved by at least 70 points from the baseline score or to below 150 (CDAI \< 150: Remission, CDAI \> 450: severe disease)
Mean Change in C-reactive Protein (CRP) Level From the Baseline After 4 and 8 Weeks of Study Drug Administration	Baseline, Weeks 4 and 8
Mean Change From the Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score After 8 Weeks of Study Drug Administration	Baseline, Week 8	The IBDQ has been frequently adopted in Japanese and overseas clinical assessments as a scale for evaluating the quality of life (QOL) of patients 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.
Clinical Improvement Rate (50) by Change in Total CDAI Score (Number of Subjects for Each Change/Number of Subjects Evaluated x 100) After 2, 4, and 8 Weeks of Study Drug Administration	Baseline, Weeks 2, 4, and 8	Definition of clinical improvement (50) : Total CDAI score improved by at least 50 points from the baseline score or to below 150 (CDAI \< 150: Remission, CDAI \> 450: severe disease)
Mean Change From the Baseline in Crohn's Disease Endoscopic Index of Severity (CDEIS) Score After 8 Weeks of Study Drug Administration	Baseline, Week 8	Large bowel endoscopic findings were assessed based on the CDEIS. The CDEIS considers deep ulcer, superficial ulcer, lesion ratio of , and ulcer ratio of the 5 pre-defined segments of the colon (small intestine, right colon, transverse colon, left colon, and rectum). The score ranges from 0 to 44 where higher scores indicate more severe disease.