Phase 3
Completed N=191
A Dose-finding and Confirmatory Trial of OPC-6535 in Patients With Active Crohn's Disease
Source: ClinicalTrials.gov NCT00989573 ↗Enrolled (actual)
191
Serious AEs
11.5%
Results posted
Apr 2021
Primary outcomePrimary: Clinical Improvement Rate (Number of Subjects Showing Clinical Improvement / Number of Subjects Evaluated × 100) After 8 Weeks of IMP Administration — 31.3; 21.0; 29.5 percentage of participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this study is to verify the safety and efficacy of OPC-6535 and determine the optimal dose by once-daily oral administration of OPC-6535 at 25 or 50 mg or placebo for 8 weeks in combination with base treatment (either a fixed oral dose of 5-aminosalicylic acid [5-ASA] or a fixed oral dose of 5-ASA plus enteral nutrition) in 180 patients with active Crohn's disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Improvement Rate (Number of Subjects Showing Clinical Improvement / Number of Subjects Evaluated × 100) After 8 Weeks of IMP Administration |
31.3; 21.0; 29.5 | — |
| SECONDARY Clinical Improvement Rate After 4 Weeks of IMP Administration |
30.2; 16.1; 28.3 | — |
| SECONDARY Remission Rate (Number of Subjects Showing Remission / Number of Subjects Evaluated x 100) After 4 and 8 Weeks of IMP Administration |
15.9; 6.5; 10.0; 20.3; 11.3; 18.0 | — |
| SECONDARY Mean Change From Baseline in C-reactive Protein (CRP) Level After 4 and 8 Weeks of IMP Administration |
-0.19; -0.16; 0.24; -0.03; -0.36; 0.34 | — |
Eligibility Criteria
Inclusion Criteria
- Primary lesion in either small intestine or large intestine
- C-reactive protein (CRP) level above the upper limit of the normal range
- Patients who have been receiving a 5-ASA formulation (oral mesalazine) at a fixed dose of 2.25 g/day or higher (not exceeding the approved dose) and at a fixed dosing regimen
- Patients who have not received enteral nutrition or who have been receiving enteral nutrition at a fixed intake of 1200 kcal/day or less
Exclusion Criteria
- Patients with an uncontrolled external fistula (including anal fistula)
- Patients with a history of total proctocolectomy or subtotal colectomy
- Patients with short bowel syndrome
- Patients with an artificial anus
- Patients with serious infectious disease (intra-abdominal abscess, etc)
- Patients with malignant tumor
- Female patients who are pregnant, lactating, or possibly pregnant, or who wish to become pregnant during the trial period
Data sourced from ClinicalTrials.gov (NCT00989573). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.