XerostomiaPhase 2NCT00233363

Exploratory Study for Dry Mouth in Patients With Sjögren's Syndrome

A Phase 2 study testing Rebamipide in people with Xerostomia and Sjogren's Syndrome, run by Otsuka Pharmaceutical Co., Ltd. at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to exploratively investigate the clinical efficacy of rebamipide on dry mouth in patients with Sjögren's syndrome in comparison with placebo. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Xerostomia, Sjogren's Syndrome
What is being tested?: Rebamipide
How many people: 104 participants
Where: 1 siteJapan
Study dates: 15 Apr 2005to 27 Jan 2006
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 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with Sjögren's syndrome (Revised Japanese criteria for Sjögren's syndrome (1999): 1998 research report on immunological intractable diseases specified by the Japanese Ministry of Health and Welfare)
Patients aged 20 years or older at time of consent
Patients with dry mouth
Patients with decreased salivation

Who cannot join

Patients who have developed dry mouth clearly due to a cause other than Sjögren's syndrome
Patients in whom Saxon test cannot be performed (artificial tooth, tooth implant, etc.)
Patients who have received rebamipide within 3 months prior to obtaining informed consent
Patients who are pregnant, possibly pregnant, or lactating
Patients with a history of hypersensitivity to rebamipide
Patients who have received any other investigational drug within 3 months prior to obtaining informed consent
Patients who are otherwise judged inappropriate for inclusion in the study by the investigator or subinvestigator

Trial locations and contacts

1 site in 1 country.

Japan1 site

Otsuka Pharmaceutical Co., Ltd.
Tokyo

Other trials in Japan

About this study

Official title: An Exploratory Study of Rebamipide to Evaluate Efficacy and Safety in the Treatment of Dry Mouth in Patients With Sjögren's Syndrome

The purpose of this study is to exploratively investigate the clinical efficacy of rebamipide on dry mouth in patients with Sjögren's syndrome in comparison with placebo.

Conditions: Xerostomia, Sjogren's Syndrome
Being tested: Rebamipide
Medical subject headings: Xerostomia, Sjogren's Syndrome

What participants receive

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

RebamipideDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

Overall Improvement Rate in Dry Mouth Symptoms
At visits to the study site at two, four, and eight weeks after the start of administration, subjects self-assessed the overall change in their dry mouth symptoms in comparison with their symptoms before the start of treatment on the following four-grade scale: (1) Markedly improved (clearly better), (2) Improved (better) , (3) Unchanged (almost no difference), and (4) Aggravated (worse).
The improvement rate was calculated by defining improvement as an assessment of either (1) Markedly improved or (2) Improved.
Measured: Weeks 2, 4, and 8

Timeline

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

15 Apr 200527 Jan 2006

First posted5 Oct 2005 (estimated)
Study start15 Apr 2005
Primary completion19 Jan 2006
Study completion27 Jan 2006

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 XerostomiaStudies 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: 104 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00233363
Sponsor's protocol ID: 037-04-001
Other IDs: JapicCTI-050036
Status last verified: May 2021
First submitted: 4 Oct 2005
Last updated: 4 Jun 2021
Results posted: Yes, on ClinicalTrials.gov

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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All Xerostomia trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Exploratory Study of Rebamipide to Evaluate Efficacy and Safety in the Treatment of Dry Mouth in Patients With Sjögren's Syndrome
ClinicalTrials.gov ID: NCT00233363
Acronym / sponsor ID: 037-04-001
Conditions: Xerostomia, Sjogren's Syndrome
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 104 participants (actual)
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 15 Apr 2005 (actual)
Primary completion: 19 Jan 2006 (actual)
Study completion: 27 Jan 2006 (actual)
First posted: 5 Oct 2005 (estimated)
Results: Posted 4 Jun 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 exploratively investigate the clinical efficacy of rebamipide on dry mouth in patients with Sjögren's syndrome in comparison with placebo.

Study design

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

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Patients with Sjögren's syndrome (Revised Japanese criteria for Sjögren's syndrome (1999): 1998 research report on immunological intractable diseases specified by the Japanese Ministry of Health and Welfare)
Patients aged 20 years or older at time of consent
Patients with dry mouth
Patients with decreased salivation

Key exclusion criteria (7 listed)

Patients who have developed dry mouth clearly due to a cause other than Sjögren's syndrome
Patients in whom Saxon test cannot be performed (artificial tooth, tooth implant, etc.)
Patients who have received rebamipide within 3 months prior to obtaining informed consent
Patients who are pregnant, possibly pregnant, or lactating
Patients with a history of hypersensitivity to rebamipide

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
Rebamipide	Drug	–

Primary outcome

Overall Improvement Rate in Dry Mouth Symptoms
Time frame: Weeks 2, 4, and 8
At visits to the study site at two, four, and eight weeks after the start of administration, subjects self-assessed the overall change in their dry mouth symptoms in comparison with their symptoms before the start of treatment on the following four-grade scale: (1) Markedly improved (clearly better), (2) Improved (better) , (3) Unchanged (almost no difference), and (4) Aggravated (worse). The improvement rate was calculated by defining improvement as an assessment of either (1) Markedly improved or (2) Improved.

Results and safety

Results posted to the registry on 4 Jun 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
Rebamipide	53	50
Placebo	51	46

Primary outcome: Overall Improvement Rate in Dry Mouth Symptoms

Time frame: Weeks 2, 4, and 8. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Rebamipide n = 50	Placebo n = 50
Week 2	26.0 (13.8 to 38.2)	20.0 (8.9 to 31.1)
Week 4	44.0 (30.2 to 57.8)	27.1 (14.5 to 39.7)
Week 8	46.9 (33.0 to 60.9)	39.1 (25.0 to 53.2)

Population analysed: The Efficacy Analysis Set comprised subjects in the Full Analysis Set (subjects received IMP at least once) excluding ineligible subjects and subjects with protocol deviations as described below: 1. Subjects violating the rules on concomitant therapy 2. Subjects with poor treatment compliance (\<80% of the prescribed dose at time of treatment discontinuation/completion) 3. Subjects with missing data on the primary endpoint at all time points

Adverse events

Time frame: Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Rebamipide	1 of 53 (1.9%)	31 of 53 (58.5%)	0 of 53
Placebo	1 of 51 (2%)	34 of 51 (66.7%)	0 of 51

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Xerostomia

Not yet recruitingPhase 1
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RecruitingPhase 1
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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

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rebamipide in people with Xerostomia and Sjogren's Syndrome, run by Otsuka Pharmaceutical Co., Ltd. at 1 site 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 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 4 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 4 Jun 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?

Overall Improvement Rate in Dry Mouth Symptoms (time frame: Weeks 2, 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 NCT00233363.

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 4 Jun 2021.