HeartburnPhase 3NCT02873689
Efficacy and Safety of Dexlansoprazole on Heartburn Relief in Chinese Patients
A Phase 3 study testing Dexlansoprazole in people with Heartburn and Gastroesophageal Reflux Disease, run by Takeda at 25 sites in China.
Trial summary
The purpose of this study is to determine the efficacy and safety of dexlansoprazole compared to placebo in relief of daytime and nighttime heartburn over 4 weeks in Chinese participants with symptomatic non-erosive Gastroesophageal Reflux Disease (GERD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heartburn, Gastroesophageal Reflux Disease
- What is being tested?
- Dexlansoprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 217 participants
- Where
- 25 sitesChina
- Study dates
- 27 Dec 2016to 19 Apr 2018
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants identifying their main symptom as a burning feeling in the mid-epigastric area and/or chest area (that is, heartburn).
- Must have a history of symptomatic GERD for 6 months or longer prior to Screening with GERD symptoms that were responsive to acid-suppressive therapy.
- Must have episodes of heartburn for 4 or more days during the 7 days prior to Day -1 as recorded in the eDiary.
Who cannot join
- Has a history of cancer (except basal cell carcinoma of the skin), that has not been in remission for at least 5 years prior to Screening.
- Has a known history of Barrett's esophagus with dysplastic changes or any changes suspicious Barrett's seen during screening endoscopy.
- Participant developed acute upper gastrointestinal bleeding, gastric ulcer (a mucosal defect with white coating) or duodenal ulcer (a mucosal defect with white coating), within 30 days before the start of the Screening Visit (with the possible inclusion of those with gastric or duodenal erosion). The participant requires chronic use (greater than [>] 12 doses per month) of nonsteroidal anti-inflammatory drugs (NSAIDs) including cyclooxygenase-2 (COX-2) NSAIDs within 30 days prior to the Screening Period and throughout the study.
- Has comorbidities that could affect the esophagus (eosinophilic esophagitis, esophageal varices, scleroderma, viral or fungal infection, esophageal strictures); a history of radiotherapy or cryotherapy of the esophagus; and a history of corrosive or physiochemical injury (with the possible inclusion in the study of those with Schatzki's ring).
- Has a history of surgical procedures that may affect the esophagus (example, fundoplication and mechanical dilatation for esophageal strictures) or a history of gastric or duodenal surgery other than endoscopic removal of benign polyps.
- Has erosive esophagitis (EE) as shown by endoscopy, during the Screening Period.
Show all 12Show fewer
- Is known to have acquired immunodeficiency syndrome (AIDS) or hepatitis, including hepatitis virus carriers: (that is, hepatitis B surface antigen HBs-antigen (HBsAg) positive or hepatitis C virus (HCV)-antibody positive).
- Has current or historical evidence of Zollinger-Ellison syndrome or a history of gastric acid hypersecretion.
- Is scheduled for surgery that requires hospitalization or requires surgical treatment during his/her participation in the study.
- Has donated or lost >300 milliliter (mL) blood volume, undergone plasmapheresis, or has had a transfusion of any blood product within 90 days prior to the first dose of study drug.
- Has a history of alcohol abuse (defined as any illicit drug use), or drug addiction in the 12 months prior to Screening.
- Participant with positive serology result of Helicobacter pylori (H. pylori) that needs eradication therapy during the study participation period as anticipated by the investigator.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
China25 sites
Peking University First Hospital
Beijing, Beijing Municipality, 100032
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Binzhou Medical University Hospital
Binzhou, Shandong, 256603
The First Hospital of Jilin University
Changchun, Jilin, 130000
The Third Hospital of Changsha
Changsha, Hunan, 410015
West China Hospital,Sichuan University
Chengdu, Si Chuang, 610041
Chongqing Three Gorges Central Hospital
Chongqing, Chong Qing, 404100
Affilicated Hospital of Guilin Medical University
Haikou, Gui Lin, 570100
Jinan Central Hospital
Jinan, Shandong, 250013
Liaocheng Hospital
Liaocheng, Shandong, 252000
Zhongda Hospital Southeast
Nanjing, Jiangsu, 210009
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, 530022
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266003
Renji Hospital Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 20001
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110004
Hebei General Hospital
Shijiazhuang, Hebei, 050051
Taihe Hospital
Shiyan, Hubei, 442000
The First Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001
The Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001
Tianjin People's Hospital
Tianjin, Tianjin Municipality, 300121
Central Hospital of Wuhan
Wuhan, Hubei, 430000
Puai Hospital Of Wuhan City
Wuhan, Hubei, 430000
Affiliated Hospital of Jiangsu University
Wuxi, Jiangsu, 212001
Wuxi people's hospital
Wuxi, Jiangsu, 214023
Zhongshan Hospital Xiamen University
Xiamen, Fujian, 361004
About this study
Official title: A Phase 3 Double-blind Study to Evaluate the Efficacy and Safety of Dexlansoprazole (30 mg QD) Compared to Placebo on Heartburn Relief in Subjects With Symptomatic Nonerosive Gastroesophageal Reflux Disease (GERD)
The purpose of this study is to determine the efficacy and safety of dexlansoprazole compared to placebo in relief of daytime and nighttime heartburn over 4 weeks in Chinese participants with symptomatic non-erosive Gastroesophageal Reflux Disease (GERD).
Read the detailed description
The drug being tested in this study is called dexlansoprazole. Dexlansoprazole is being tested to treat heartburn in people who have non-erosive gastroesophageal reflux disease (GERD). This study will look at heartburn relief in people who take dexlansoprazole.
The study will enroll approximately 200 participants. Participants will be randomly assigned to one of the two treatment groups with 1:1 ratio -which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need):
- Dexlansoprazole 30 mg
- Placebo (dummy inactive pill) - this is a capsule that looks like the study drug but has no active ingredient.
All participants will be asked to take one capsule at the same time each day throughout the study, and will be asked to record any time they have heartburn symptoms in a diary.
This multi-center trial will be conducted in China. The overall time to participate in this study is up to 7 weeks. Participants will make 4 visits to the clinic, and will be contacted by telephone 5 to 10 days after the last dose of study drug for a follow-up assessment.
- Conditions
- Heartburn, Gastroesophageal Reflux Disease
- Being tested
- Dexlansoprazole, Placebo
- Keywords
- Drug therapy
- Medical subject headings
- Heartburn, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexlansoprazoleDrug
Dexlansoprazole delayed-release capsule
PlaceboDrug
Dexlansoprazole placebo-matching capsules
| Study group | Role | What they receive |
|---|---|---|
| Dexlansoprazole 30 mg | Experimental | Dexlansoprazole 30 mg, delayed-release capsule, orally, once daily for up to 4 weeks. Receives: Drug: Dexlansoprazole |
| Placebo | Experimental | Dexlansoprazole placebo-matching capsules, orally, once daily for up to 4 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment
The percentage of days with neither daytime nor nighttime heartburn was equal to (=) (the days that were heartburn-free during the treatment period) / (total number of days for which either a daytime or nighttime result was marked during treatment period)*100 percent (%).
Measured: Up to Week 4
Secondary outcomes (1)
Percentage of Days Without Nighttime Heartburn During Treatment
The percentage of days without nighttime heartburn was = (the days that were heartburn-free during the treatment period) / (total number of days for which nighttime result was marked during treatment period)*100%.
Measured: Up to Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2016 (estimated)
- Study start27 Dec 2016
- Primary completion14 Mar 2018
- Study completion19 Apr 2018
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 HeartburnStudies of the same condition, open and under way.
- More trials run by TakedaThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02873689
- Sponsor's protocol ID
- TAK-390MR_302
- Other IDs
- U1111-1171-1002
- Status last verified
- Jul 2019
- First submitted
- 17 Aug 2016
- Last updated
- 5 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Double-blind Study to Evaluate the Efficacy and Safety of Dexlansoprazole (30 mg QD) Compared to Placebo on Heartburn Relief in Subjects With Symptomatic Nonerosive Gastroesophageal Reflux Disease (GERD)
- ClinicalTrials.gov ID
- NCT02873689
- Acronym / sponsor ID
- TAK-390MR_302
- Conditions
- Heartburn, Gastroesophageal Reflux Disease
- Keywords
- Drug therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 27 Dec 2016 (actual)
- Primary completion
- 14 Mar 2018 (actual)
- Study completion
- 19 Apr 2018 (actual)
- First posted
- 19 Aug 2016 (estimated)
- Results
- Posted 5 Jul 2019
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 determine the efficacy and safety of dexlansoprazole compared to placebo in relief of daytime and nighttime heartburn over 4 weeks in Chinese participants with symptomatic non-erosive Gastroesophageal Reflux Disease (GERD).
Detailed description
The drug being tested in this study is called dexlansoprazole. Dexlansoprazole is being tested to treat heartburn in people who have non-erosive gastroesophageal reflux disease (GERD). This study will look at heartburn relief in people who take dexlansoprazole.
The study will enroll approximately 200 participants. Participants will be randomly assigned to one of the two treatment groups with 1:1 ratio -which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need):
- Dexlansoprazole 30 mg
- Placebo (dummy inactive pill) - this is a capsule that looks like the study drug but has no active ingredient.
All participants will be asked to take one capsule at the same time each day throughout the study, and will be asked to record any time they have heartburn symptoms in a diary.
This multi-center trial will be conducted in China. The overall time to participate in this study is up to 7 weeks. Participants will make 4 visits to the clinic, and will be contacted by telephone 5 to 10 days after the last dose of study drug for a follow-up assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexlansoprazole 30 mg | Experimental | Drug: DexlansoprazoleDexlansoprazole 30 mg, delayed-release capsule, orally, once daily for up to 4 weeks. |
| Placebo | Experimental | Drug: PlaceboDexlansoprazole placebo-matching capsules, orally, once daily for up to 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants identifying their main symptom as a burning feeling in the mid-epigastric area and/or chest area (that is, heartburn).
- Must have a history of symptomatic GERD for 6 months or longer prior to Screening with GERD symptoms that were responsive to acid-suppressive therapy.
- Must have episodes of heartburn for 4 or more days during the 7 days prior to Day -1 as recorded in the eDiary.
Key exclusion criteria (12 listed)
- Has a history of cancer (except basal cell carcinoma of the skin), that has not been in remission for at least 5 years prior to Screening.
- Has a known history of Barrett's esophagus with dysplastic changes or any changes suspicious Barrett's seen during screening endoscopy.
- Participant developed acute upper gastrointestinal bleeding, gastric ulcer (a mucosal defect with white coating) or duodenal ulcer (a mucosal defect with white coating), within 30 days before the start of the Screening Visit (with the possible inclusion of those with gastric or duodenal erosion). The participant requires chronic use (greater than [>] 12 doses per month) of nonsteroidal anti-inflammatory drugs (NSAIDs) including cyclooxygenase-2 (COX-2) NSAIDs within 30 days prior to the Screening Period and throughout the study.
- Has comorbidities that could affect the esophagus (eosinophilic esophagitis, esophageal varices, scleroderma, viral or fungal infection, esophageal strictures); a history of radiotherapy or cryotherapy of the esophagus; and a history of corrosive or physiochemical injury (with the possible inclusion in the study of those with Schatzki's ring).
- Has a history of surgical procedures that may affect the esophagus (example, fundoplication and mechanical dilatation for esophageal strictures) or a history of gastric or duodenal surgery other than endoscopic removal of benign polyps.
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 |
|---|---|---|
| DexlansoprazoleDexlansoprazole delayed-release capsule | Drug | Dexlansoprazole 30 mg |
| PlaceboDexlansoprazole placebo-matching capsules | Drug | Placebo |
Primary outcome
Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment
Time frame: Up to Week 4
The percentage of days with neither daytime nor nighttime heartburn was equal to (=) (the days that were heartburn-free during the treatment period) / (total number of days for which either a daytime or nighttime result was marked during treatment period)*100 percent (%).
1 secondary outcome
Percentage of Days Without Nighttime Heartburn During Treatment
Time frame: Up to Week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Dexlansoprazole Package InsertLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
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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.
Medical Director study director
Takeda
25 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 Dexlansoprazole in people with Heartburn and Gastroesophageal Reflux Disease, run by Takeda at 25 sites in China.
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 12 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 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in China. 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?
Yes. Results are posted in the registry (first posted 5 Jul 2019). 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?
Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment (time frame: Up to Week 4). 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 5 Jul 2019.