Crohn's DiseasePhase 2/3NCT00989573
A Dose-finding and Confirmatory Trial of OPC-6535 in Patients With Active Crohn's Disease
A Phase 2/3 study testing OPC-6535 in people with Crohn's Disease, run by Otsuka Pharmaceutical Co., Ltd. at 11 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- OPC-6535
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 191 participants
- Where
- 11 sitesin 2 countries
- Study dates
- Oct 2009to Aug 2012
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
Japan7 sites
Study site
Chubu Region
Study site
Chugoku Region
Study site
Hokkaido Region
Study site
Kanto Region
Study site
Kinki Region
Study site
Kyushu Region
Study site
Tohoku Region
South Korea4 sites
Study site
Busan
Study site
Daegu
Study site
Gyronggi-do
Study site
Seoul
About this study
Official title: A Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-finding and Confirmatory Trial of OPC-6535 in Patients With Active Crohn's Disease
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.
- Conditions
- Crohn's Disease
- Being tested
- Placebo, OPC-6535
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
oral administration of placebo once-daily for 8 weeks
OPC-6535Drug
oral administration of OPC-6535 25 mg once-daily for 8 weeks
OPC-6535Drug
oral administration of OPC-6535 50 mg once-daily for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | oral administration of placebo once-daily for 8weeks Receives: Drug: Placebo |
| OPC-6535 25 mg | Experimental | oral administration of OPC-6535 25 mg once-daily for 8 weeks Receives: Drug: OPC-6535 |
| OPC-6535 50 mg | Experimental | oral administration of OPC-6535 50mg once-daily for 8 weeks Receives: Drug: OPC-6535 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Improvement Rate (Number of Subjects Showing Clinical Improvement / Number of Subjects Evaluated × 100) After 8 Weeks of IMP Administration
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)
Measured: Week 8
Secondary outcomes (3)
Clinical Improvement Rate After 4 Weeks of IMP Administration
Definition of clinical improvement: CDAI score improved by at least 70 points from the baseline score or to below 150 (CDAI < 150: remission, CDAI > 450: severe disease)
Measured: Week 4
Remission Rate (Number of Subjects Showing Remission / Number of Subjects Evaluated x 100) After 4 and 8 Weeks of IMP Administration
Definition of remission: Total CDAI score improved to below 150
Measured: Weeks 4 and 8
Mean Change From Baseline in C-reactive Protein (CRP) Level After 4 and 8 Weeks of IMP Administration
Measured: Baseline, Weeks 4 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 191 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Katsuhisa Saito, Study chair, OPCJ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00989573
- Sponsor's protocol ID
- 197-08-001
- Other IDs
- JapicCTI090915
- Status last verified
- Mar 2021
- First submitted
- 2 Oct 2009
- Last updated
- 6 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-finding and Confirmatory Trial of OPC-6535 in Patients With Active Crohn's Disease
- ClinicalTrials.gov ID
- NCT00989573
- Acronym / sponsor ID
- 197-08-001
- Conditions
- Crohn's Disease
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 191 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 5 Oct 2009 (estimated)
- Results
- Posted 6 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebooral administration of placebo once-daily for 8weeks |
| OPC-6535 25 mg | Experimental | Drug: OPC-6535oral administration of OPC-6535 25 mg once-daily for 8 weeks |
| OPC-6535 50 mg | Experimental | Drug: OPC-6535oral administration of OPC-6535 50mg once-daily for 8 weeks |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebooral administration of placebo once-daily for 8 weeks | Drug | Placebo |
| OPC-6535oral administration of OPC-6535 25 mg once-daily for 8 weeks | Drug | OPC-6535 25 mg |
| OPC-6535oral administration of OPC-6535 50 mg once-daily for 8 weeks | Drug | OPC-6535 50 mg |
Primary outcome
Clinical Improvement Rate (Number of Subjects Showing Clinical Improvement / Number of Subjects Evaluated × 100) After 8 Weeks of IMP Administration
Time frame: 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)
3 secondary outcomes
Clinical Improvement Rate After 4 Weeks of IMP Administration
Time frame: Week 4
Remission Rate (Number of Subjects Showing Remission / Number of Subjects Evaluated x 100) After 4 and 8 Weeks of IMP Administration
Time frame: Weeks 4 and 8
Mean Change From Baseline in C-reactive Protein (CRP) Level After 4 and 8 Weeks of IMP Administration
Time frame: Baseline, Weeks 4 and 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katsuhisa Saito study chair
OPCJ
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing OPC-6535 in people with Crohn's Disease, run by Otsuka Pharmaceutical Co., Ltd. at 11 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Japan, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Improvement Rate (Number of Subjects Showing Clinical Improvement / Number of Subjects Evaluated × 100) After 8 Weeks of IMP Administration (time frame: Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2021.