HeartburnPhase 3NCT00389948
Efficacy/Safety of Lansoprazole in Patients With Frequent Heartburn
A Phase 3 study testing Lanzoprazole in people with Heartburn, run by Novartis at 28 sites in United States.
Trial summary
Heartburn, a burning sensation in the chest or throat, occurs in many patients when acidic stomach contents move into the esophagus from the stomach. This study will investigate the safety and efficacy of lansoprazole 15 mg once a day in treating frequent heartburn. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heartburn
- What is being tested?
- Lanzoprazole
- How many people
- 576 participants
- Where
- 28 sitesUnited States
- Study dates
- Jun 2006to Jan 2007
- Phase
- Phase 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Experiencing heartburn at least 2 days per week over the past month.
- Having heartburn that responds to heartburn medication.
- Be willing to discontinue the use of heartburn treatment for 7 days prior to inclusion in the study.
Who cannot join
- Having history of erosive esophagitis or gastroesophageal reflux disease diagnosed by a physician and confirmed by testing (endoscopy).
- Be unwilling to take only the study medication, and antacid provided as a rescue medication for relief of acute heartburn during the study.
- Other protocol-defined inclusion or exclusion criteria may apply
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
United States28 sites
Radiant Research
Atlanta, Georgia, 30252
Radiant Research
Atlanta, Georgia, 30308
Preferred Primary Care Physicians
Carnegie, Pennsylvania, 15106
Micheal Alexander, DO
Columbus, Ohio, 43204
Medical Edge Healthcare Group, P.A.
Dallas, Texas, 75243
Study site
Evansville, Indiana, 47714
Benchmark Research
Fort Worth, Texas, 76135
Eastern Research
Hialeah, Florida, 33013
Clinical Research Consultants Inc.
Hoover, Alabama, 35216
Study site
Huntsville, Alabama, 35802
Advanced Therapeutics, Inc
Johnson City, Tennessee, 37601
Health Awareness Inc.
Jupiter, Florida, 33458
Radiant Research
Lakewood, Washington, 98499
California Bio Medical Research Institute
Los Angeles, California, 90025
Miami Research Associates
Miami, Florida, 33173
Nashville Medical Research
Nashville, Tennessee, 37205
Meridian Clinical Research LLC
Omaha, Nebraska, 68134
IRSI
Port Chester, New York, 10573
New Hope Research of Oregon
Portland, Oregon, 97219
Clinical Associates
Reisterstown, Maryland, 21136
Commonwealth Clinical Research Specialist
Richmond, Virginia, 23226
National Clinical Research Inc.
Richmond, Virginia, 23294
William W. Anderson M.D. P.C.
Rio Rancho, New Mexico, 87124
Allergy Medical Group of North Area
Roseville, California, 95678
Crescent Medical Research
Salisbury, North Carolina, 28144
Benchmark Research
San Angelo, Texas, 76904
Radiant Research
Sierra Vista, Arizona, 85635
Medex Healthcare Research, Inc.
St Louis, Missouri, 63117
About this study
Official title: A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial of 14 Day Treatment With Lansoprazole 15 mg Once a Day in Frequent Heartburn
Heartburn, a burning sensation in the chest or throat, occurs in many patients when acidic stomach contents move into the esophagus from the stomach. This study will investigate the safety and efficacy of lansoprazole 15 mg once a day in treating frequent heartburn.
- Conditions
- Heartburn
- Being tested
- Lanzoprazole
- Keywords
- Heartburn, frequent heartburn, proton pump inhibitor, lansoprazole
- Medical subject headings
- Heartburn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LanzoprazoleDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate that repeated daily doses of 15 mg of lansoprazole are effective in increasing the proportion of days with no heartburn during study treatment, when compared to placebo.
Secondary outcomes (3)
To determine the proportion of nighttimes with no heartburn during 14 days of treatment in subjects receiving lansoprazole versus placebo
To determine the proportion of subjects with no heartburn during day 1 in those receiving lansoprazole versus placebo
Evaluation of lansoprazole safety.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2006 (estimated)
- Study startJun 2006
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HeartburnStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 576 participants
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00389948
- Sponsor's protocol ID
- PRSW-GN-301
- Status last verified
- Apr 2007
- First submitted
- 18 Oct 2006
- Last updated
- 16 Apr 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial of 14 Day Treatment With Lansoprazole 15 mg Once a Day in Frequent Heartburn
- ClinicalTrials.gov ID
- NCT00389948
- Acronym / sponsor ID
- PRSW-GN-301
- Conditions
- Heartburn
- Keywords
- Heartburn, frequent heartburn, proton pump inhibitor, lansoprazole
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 576 participants
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Study completion
- Jan 2007 (actual)
- First posted
- 19 Oct 2006 (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.
Heartburn, a burning sensation in the chest or throat, occurs in many patients when acidic stomach contents move into the esophagus from the stomach. This study will investigate the safety and efficacy of lansoprazole 15 mg once a day in treating frequent heartburn.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Experiencing heartburn at least 2 days per week over the past month.
- Having heartburn that responds to heartburn medication.
- Be willing to discontinue the use of heartburn treatment for 7 days prior to inclusion in the study.
Key exclusion criteria (3 listed)
- Having history of erosive esophagitis or gastroesophageal reflux disease diagnosed by a physician and confirmed by testing (endoscopy).
- Be unwilling to take only the study medication, and antacid provided as a rescue medication for relief of acute heartburn during the study.
- Other protocol-defined inclusion or exclusion criteria may apply
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 |
|---|---|---|
| Lanzoprazole | Drug | – |
Primary outcome
To demonstrate that repeated daily doses of 15 mg of lansoprazole are effective in increasing the proportion of days with no heartburn during study treatment, when compared to placebo.
3 secondary outcomes
To determine the proportion of nighttimes with no heartburn during 14 days of treatment in subjects receiving lansoprazole versus placebo
To determine the proportion of subjects with no heartburn during day 1 in those receiving lansoprazole versus placebo
Evaluation of lansoprazole safety.
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 16 Apr 2007.
Related trials for Heartburn
RecruitingPhase 3
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Symptomatic Non-erosive Gastroesophageal Reflux Disease
Active, not recruitingPhase 3
Domperidone in Treating Patients With Gastrointestinal Disorders
Digestive System Disorder, Dyspepsia
RecruitingObservational study
A Study of the Safety of Vonoprazan Exposure in Pregnant Women and Their Offspring
Erosive Esophagitis, Heartburn
Enrolling by invitationObservational study
The Johns Hopkins Heartburn Center Registry
Gastroesophageal Reflux Disease, Barrett Esophagus
Not yet recruiting
Antireflux Surgery Without Preoperative Esophageal Manometry
GERD, Hiatal Hernia
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.
The record lists no contact. Use the official record to reach the sponsor.
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lanzoprazole in people with Heartburn, run by Novartis at 28 sites in United States.
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: finished, as of the sponsor's last update on 16 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States. 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 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?
To demonstrate that repeated daily doses of 15 mg of lansoprazole are effective in increasing the proportion of days with no heartburn during study treatment, when compared to placebo.. 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 16 Apr 2007.