Gastroesophageal RefluxPhase 2/3NCT00141960
Famotidine in Subjects With Non-erosive Gastroesophageal Reflux Disease
A Phase 2/3 study testing Famotidine in people with Gastroesophageal Reflux, run by Astellas Pharma Inc at 7 sites in Japan.
Trial summary
Gastroesophageal reflux disease (GERD) considered to be associated with mucosal damages in the esophagus and heartburn, which may sometimes interfere with daily activities due likely to reflux of acid gastric contents. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Gastroesophageal Reflux
- What is being tested?
- Famotidine
- How many people
- 480 participants
- Where
- 7 sitesJapan
- Study dates
- Sep 2005to not given
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 have heartburn with non-erosive gastroesophageal reflux disease.
Who cannot join
- Patients have diseases which interfere with evaluation of the efficacy and safety in this study.
- Patients are receiving and/or have received prior to the enrollment the treatment which interfere with evaluation of the efficacy and safety in this study.
- Patients have severe cardiovascular, hepatic, renal and hematological disorders.
- Patients are allergic to or have a history of drug allergy to H2RA.
- Patients have or have a history of malignant tumors.
- Patients are pregnant or a lactating mother.
- Patients have participated in other clinical studies less than 12 weeks prior to submitting the informed consent.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Japan7 sites
Study site
Hokkaido Region
Study site
Kanto Region
Study site
Kinki Region
Study site
Kyushu Region
Study site
Shikoku Region
Study site
Tohoku Region
Study site
Tokai Region
About this study
Official title: YM1170 Phase 2/3 Study: A Double Blind, Placebo Controlled, Group-comparison Study in Patients With Non-erosive Gastroesophageal Reflux Disease
Gastroesophageal reflux disease (GERD) considered to be associated with mucosal damages in the esophagus and heartburn, which may sometimes interfere with daily activities due likely to reflux of acid gastric contents. While most of the patients given the diagnosis of GERD do not exhibit endoscopically obvious impairment in esophageal mucous membrane, they have subjective symptoms of non-erosive GERD including heartburn. But no drug has been launched in Japan, which targets non-erosive GERD. This study will examine the efficacy and safety of famotidine in subjects with non-erosive GERD.
- Conditions
- Gastroesophageal Reflux
- Being tested
- Famotidine
- Keywords
- Treatment efficacy, Treatment effectiveness, Gastrointestinal Diseases, Reflux, Gastroesophageal, GERD
- Medical subject headings
- Gastroesophageal Reflux, Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FamotidineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of days with no heart burn in the treatment period
Secondary outcomes (5)
Disappearance of heart burn
Severity of heart burn
Frequency of heart burn
Patient's final global improvement rating
Other symptoms (e.g.,reflux sensation of gastric fluid, discomfort of pharynges)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2005 (estimated)
- Study startSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal RefluxStudies of the same condition, open and under way.
- 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
- Double blind
- Enrolment
- 480 participants
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Study Director, Study chair, Clinical Development III, Astellas Pharm. Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00141960
- Sponsor's protocol ID
- 1170-CL-004
- Status last verified
- Jun 2010
- First submitted
- 1 Sep 2005
- Last updated
- 21 Nov 2011
- Results posted
- No
Publications
Hongo M, Kinoshita Y, Haruma K. A randomized, double-blind, placebo-controlled clinical study of the histamine H2-receptor antagonist famotidine in Japanese patients with nonerosive reflux disease. J Gastroenterol. 2008;43(6):448-56. doi: 10.1007/s00535-008-2186-5. Epub 2008 Jul 4.
PubMed 18600389
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- YM1170 Phase 2/3 Study: A Double Blind, Placebo Controlled, Group-comparison Study in Patients With Non-erosive Gastroesophageal Reflux Disease
- ClinicalTrials.gov ID
- NCT00141960
- Acronym / sponsor ID
- 1170-CL-004
- Conditions
- Gastroesophageal Reflux
- Keywords
- Treatment efficacy, Treatment effectiveness, Gastrointestinal Diseases, Reflux, Gastroesophageal, GERD
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 480 participants
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- First posted
- 2 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Gastroesophageal reflux disease (GERD) considered to be associated with mucosal damages in the esophagus and heartburn, which may sometimes interfere with daily activities due likely to reflux of acid gastric contents. While most of the patients given the diagnosis of GERD do not exhibit endoscopically obvious impairment in esophageal mucous membrane, they have subjective symptoms of non-erosive GERD including heartburn. But no drug has been launched in Japan, which targets non-erosive GERD. This study will examine the efficacy and safety of famotidine in subjects with non-erosive GERD.
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 (1 listed)
- Patients have heartburn with non-erosive gastroesophageal reflux disease.
Key exclusion criteria (7 listed)
- Patients have diseases which interfere with evaluation of the efficacy and safety in this study.
- Patients are receiving and/or have received prior to the enrollment the treatment which interfere with evaluation of the efficacy and safety in this study.
- Patients have severe cardiovascular, hepatic, renal and hematological disorders.
- Patients are allergic to or have a history of drug allergy to H2RA.
- Patients have or have a history of malignant tumors.
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 |
|---|---|---|
| Famotidine | Drug | – |
Primary outcome
Rate of days with no heart burn in the treatment period
5 secondary outcomes
Disappearance of heart burn
Severity of heart burn
Frequency of heart burn
Patient's final global improvement rating
Other symptoms (e.g.,reflux sensation of gastric fluid, discomfort of pharynges)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2011.
- Background: PubMed 18600389Hongo M, Kinoshita Y, Haruma K. A randomized, double-blind, placebo-controlled clinical study of the histamine H2-receptor antagonist famotidine in Japanese patients with nonerosive reflux disease. J Gastroenterol. 2008;43(6):448-56. doi: 10.1007/s00535-008-2186-5. Epub 2008 Jul 4.
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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.
Study Director study chair
Clinical Development III, Astellas Pharm. Inc.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Famotidine in people with Gastroesophageal Reflux, run by Astellas Pharma Inc at 7 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 1 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 21 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of days with no heart burn in the treatment period. 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 NCT00141960, which also lists 1 linked publication.
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 21 Nov 2011.