Colitis, UlcerativePhase 2NCT00317356

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

A Phase 2 study testing OPC-6535(Tetomilast) in people with Colitis, Ulcerative, run by Otsuka Pharmaceutical Co., Ltd. at 8 sites in Japan.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Colitis, Ulcerative
What is being tested?: OPC-6535(Tetomilast)
How many people: 43 participants
Where: 8 sitesJapan
Study dates: May 2006to Aug 2007
Phase: Phase 2
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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

Japan8 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
Shikoku Region
Study site
Touhoku Region

Other trials in Japan

About this study

Conditions: Colitis, Ulcerative
Being tested: OPC-6535(Tetomilast)
Keywords: OPC-6535, ulcerative colitis
Medical subject headings: Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OPC-6535(Tetomilast)Drug

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 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
Measured: Weeks 4 and 8

Secondary outcomes (7)

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
Measured: Weeks 4 and 8
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.
Measured: Baseline, Weeks 4 and 8
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.
Measured: Baseline, Weeks 4 and 8
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).
Measured: Baseline, Weeks 2, 4 and 8
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.
Measured: Baseline and Week 8
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.
Measured: Baseline and Week 8
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
Measured: Week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2006Aug 2007

First posted24 Apr 2006 (estimated)
Study startMay 2006
Primary completionAug 2007
Study completionAug 2007

Why it stopped: Efficacy was not cleared at US study

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 Colitis, UlcerativeStudies 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
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 43 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00317356
Sponsor's protocol ID: 197-05-002
Other IDs: JapicCTI-060216
Status last verified: Apr 2021
First submitted: 21 Apr 2006
Last updated: 30 Apr 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Dose-finding Study of OPC-6535 in Patients With Active Ulcerative Colitis
ClinicalTrials.gov ID: NCT00317356
Acronym / sponsor ID: 197-05-002
Conditions: Colitis, Ulcerative
Keywords: OPC-6535, ulcerative colitis
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Efficacy was not cleared at US study
Enrolment: 43 participants (actual)
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: May 2006
Primary completion: Aug 2007 (actual)
Study completion: Aug 2007 (actual)
First posted: 24 Apr 2006 (estimated)
Results: Posted 30 Apr 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (3 listed)

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

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
OPC-6535(Tetomilast)	Drug	–

Primary outcome

Clinical Improvement Rate (Number of Subjects Showing Clinical Improvement/Number of Subjects Evaluated x 100) After 8 Weeks of Study Drug Administration
Time frame: Weeks 4 and 8
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

7 secondary outcomes

Remission Rate (Number of Subjects Showing Remission/Number of Subjects Evaluated x 100) After 4 and 8 Weeks of Study Drug Administration
Time frame: Weeks 4 and 8
Mean Change From the Baseline in Total DAI Score After 4 and 8 Weeks of Study Drug Administration
Time frame: Baseline, Weeks 4 and 8
Mean Change From the Baseline in DAI Subscores After 4 and 8 Weeks of Study Drug Administration
Time frame: Baseline, Weeks 4 and 8
Mean Change From the Baseline in Total Clinical Activity Index (CAI) Score After 2, 4, and 8 Weeks of Study Drug Administration
Time frame: Baseline, Weeks 2, 4 and 8
Mean Change From the Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score After 8 Weeks of Study Drug Administration
Time frame: Baseline and Week 8
Mean Change From the Baseline in IBDQ Subscale Scores After 8 Weeks of Study Drug Administration
Time frame: Baseline and Week 8
Clinical Improvement Rate After 4 Weeks of Study Drug Administration
Time frame: Week 4

Results and safety

Results posted to the registry on 30 Apr 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
OPC-6535 12.5 mg	11	10
OPC-6535 25 mg	11	9
OPC-6535 50 mg	10	9
Placebo	11	8

Primary outcome: Clinical Improvement Rate (Number of Subjects Showing Clinical Improvement/Number of Subjects Evaluated x 100) After 8 Weeks of Study Drug Administration

Time frame: Weeks 4 and 8. Number (95% Confidence Interval). Unit: percentage of participants

Measure	OPC-6535 12.5 mg n = 11	OPC-6535 25 mg n = 11	OPC-6535 50 mg n = 10	Placebo n = 11
Value	27.3 (6.0 to 61.0)	30.0 (6.7 to 65.2)	50.0 (18.7 to 81.3)	9.1 (0.2 to 41.3)

Population analysed: Efficacy was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the efficacy endpoints.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Treatment period (8 weeks). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
OPC-6535 12.5 mg	0 of 11 (0%)	6 of 11 (54.5%)	0 of 11
OPC-6535 25 mg	2 of 11 (18.2%)	7 of 11 (63.6%)	0 of 11
OPC-6535 50 mg	2 of 10 (20%)	7 of 10 (70%)	0 of 10
Placebo	1 of 11 (9.1%)	8 of 11 (72.7%)	0 of 11

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 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 director

Division of New Product Evaluation and Development

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing OPC-6535(Tetomilast) in people with Colitis, Ulcerative, run by Otsuka Pharmaceutical Co., Ltd. at 8 sites in Japan.

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 3 inclusion and 3 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: stopped early, as of the sponsor's last update on 30 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 8 sites in Japan. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this 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.

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 30 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 x 100) After 8 Weeks of Study Drug Administration (time frame: Weeks 4 and 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00317356.

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 30 Apr 2021.