CompletedNCT02873689Updated Jul 5, 2019Results posted

Efficacy and Safety of Dexlansoprazole on Heartburn Relief in Chinese Patients

A Phase 3 interventional study of Dexlansoprazole and Placebo in Heartburn and Gastroesophageal Reflux Disease, sponsored by Takeda. Completed at 25 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-05.

Sponsored by Takeda · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 217
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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 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 studied

Heartburn
Gastroesophageal Reflux Disease

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Keywords

Drug therapy

In context

Heartburn

154 studies on the registry are indexed under Heartburn; 12 are open to participants now.

This study's enrollment of 217 is above the median of 100 across 127 interventional studies indexed under Heartburn.

Browse Heartburn studies →

Lead sponsor

Takeda is the lead sponsor of 1,026 studies on the registry; 88 are open to participants now.

Of its 178 completed or terminated interventional studies of FDA-regulated products, 154 (87%) have results posted.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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.
Is known to have acquired immunodeficiency syndrome (AIDS) or hepatitis, including hepatitis virus carriers: (that is, surface antigen HBs-antigen (HBsAg) positive or 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.

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 217 participants (actual)

Study arms

Experimental
Dexlansoprazole 30 mg
Dexlansoprazole 30 mg, delayed-release capsule, orally, once daily for up to 4 weeks.
Drug: Dexlansoprazole
Experimental
Placebo
Dexlansoprazole placebo-matching capsules, orally, once daily for up to 4 weeks.
Drug: Placebo

Interventions

DrugDexlansoprazole
Dexlansoprazole delayed-release capsule
DrugPlacebo
Dexlansoprazole placebo-matching capsules

What researchers measure

Primary outcomes

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 (%).
Time frame: Up to Week 4

Secondary outcomes

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%.
Time frame: Up to Week 4

Results

Posted Jul 5, 2019

Participant flow

Participants took part in the study at 20 investigative sites in China from 27 December 2016 to 19 April 2018.

Participant flow — Overall Study
Milestone	Placebo	Dexlansoprazole 30 mg
Started	109	108
Treated	108	107
Completed	102	103
Not completed	7	5
Withdrew: Lack of efficacy	1	0
Withdrew: Withdrawal by subject	2	2
Withdrew: Protocol violation	1	0
Withdrew: Adverse event	2	2
Withdrew: Randomized but not treated	1	1

Outcome measures

PrimaryPercentage 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 (%).

Time frame:: Up to Week 4
Reported as:: Median · percentage of days

Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment
percentage of days	Placebo	Dexlansoprazole 30 mg
Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment	32.67 (0.0 to 100.0)	51.72 (0.0 to 100.0)

Statistical analysis

Placebo vs Dexlansoprazole 30 mg · Wilcoxon rank-sum test · p = 0.057

SecondaryPercentage 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%.

Time frame:: Up to Week 4
Reported as:: Median · percentage of days

Percentage of Days Without Nighttime Heartburn During Treatment
percentage of days	Placebo	Dexlansoprazole 30 mg
Percentage of Days Without Nighttime Heartburn During Treatment	54.67 (0.0 to 100.0)	67.86 (0.0 to 100.0)

Statistical analysis

Placebo vs Dexlansoprazole 30 mg · Wilcoxon rank-sum test · p = 0.268

Adverse events

Collected over Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug (approximately Week 8).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Placebo	0/108 (0%)	0/108 (0%)	15/108 (13.9%)
Dexlansoprazole 30 mg	0/107 (0%)	1/107 (0.9%)	9/107 (8.4%)

Most frequent serious events

Most frequent serious events
Event	Placebo	Dexlansoprazole 30 mg
Animal scratchInjury, poisoning and procedural complications	0/108	1/107

Most frequent other events

Most frequent other events
Event	Placebo	Dexlansoprazole 30 mg
Upper respiratory tract infectionInfections and infestations	8/108	5/107
NasopharyngitisInfections and infestations	7/108	4/107

Baseline characteristics

The safety analysis set included all randomized participants who received at least 1 dose of study drug.

Age, Continuous
Age, Continuous(years)	Placebo	Dexlansoprazole 30 mg	Total
Mean	45.1 ± 12.73	43.6 ± 13.24	44.3 ± 12.98

Sex: Female, Male
Sex: Female, Male(Participants)	Placebo	Dexlansoprazole 30 mg	Total
Female	65	60	125
Male	43	47	90

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Placebo	Dexlansoprazole 30 mg	Total
American Indian or Alaska Native	0	0	0
Asian	108	107	215
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	0	0	0
White	0	0	0
More than one race	0	0	0
Unknown or Not Reported	0	0	0

Region of Enrollment
Region of Enrollment(Participants)	Placebo	Dexlansoprazole 30 mg	Total
China	108	107	215

Body mass index
Body mass index(kilogram per square meter (kg/m^2))	Placebo	Dexlansoprazole 30 mg	Total
Mean	23.935 ± 3.4352	23.701 ± 3.5768	23.819 ± 3.5002

Helicobacter pylori status
Helicobacter pylori status(Participants)	Placebo	Dexlansoprazole 30 mg	Total
Positive	41	40	81
Negative	67	67	134

Number of days with day and nighttime heartburn between study days -8 to -2
Number of days with day and nighttime heartburn between study days -8 to -2(days)	Placebo	Dexlansoprazole 30 mg	Total
Mean	6.1 ± 1.27	6.1 ± 1.06	6.1 ± 1.17

Number of days with nighttime heartburn between study days -8 to -2
Number of days with nighttime heartburn between study days -8 to -2(days)	Placebo	Dexlansoprazole 30 mg	Total
Mean	5.2 ± 1.83	5.3 ± 1.60	5.2 ± 1.71

7 further baseline measures are reported on the registry.

Study locations

25 sites

Peking University First Hospital
Beijing, Beijing 100032, China
Peking Union Medical College Hospital
Beijing, Beijing 100730, China
Chongqing Three Gorges Central Hospital
Chong Qing, Chong Qing 404100, China
Zhongshan Hospital Xiamen University
Xia Men, Fu Jian 361004, China
The People's Hospital of Guangxi Zhuang Autonomous Region
Nan Ning, Guang XI 530022, China
Affilicated Hospital of Guilin Medical University
Hai Kou, Gui Lin 570100, China
Hebei General Hospital
Shijiazhuang, Hebei 050051, China
Taihe Hospital
Shi Yan, Hu Bei 442000, China
Central Hospital of Wuhan
Wuhan, Hu Bei 430000, China
Puai Hospital Of Wuhan City
Wuhan, Hu Bei 430000, China
The Third Hospital of Changsha
Chang Sha, Hu Nan 410015, China
Zhongda Hospital Southeast
Nan Jing, Jiang Su 210009, China
Affiliated Hospital of Jiangsu University
Wu XI, Jiang Su 212001, China
Wuxi people's hospital
Wu XI, Jiang Su 214023, China
The First Hospital of Jilin University
Changchun, Jilin 130000, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning 110004, China
Binzhou Medical University Hospital
Binzhou, Shandong 256603, China
Jinan Central Hospital
Jinan, Shandong 250013, China
Liaocheng Hospital
Liaocheng, Shandong 252000, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong 266003, China
Renji Hospital Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai 20001, China
The First Hospital of Shanxi Medical University
Taiyuan, Shanxi 030001, China
The Second Hospital of Shanxi Medical University
Taiyuan, Shanxi 030001, China
West China Hospital,Sichuan University
Cheng Du, Si Chuang 610041, China
Tianjin People's Hospital
Tianjin, Tianjin 300121, China

References and documents

Study documents

Statistical analysis plan ↗ · Dec 7, 2018
Study protocol ↗ · Feb 20, 2017

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: 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.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Ran from Dec 2016 to primary completion in Mar 2018, 14 months.

Results were first posted in Jul 2019, 1 year 3 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered: Aug 17, 2016
First posted: Aug 19, 2016
StartActual: Dec 27, 2016
Primary completionActual: Mar 14, 2018
CompletionActual: Apr 19, 2018
Results first posted: Jul 5, 2019
Last update: Jul 5, 2019

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Jul 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02873689
Lead sponsor: Takeda
Responsible party: Sponsor
First posted: Aug 19, 2016
Start date: Dec 27, 2016
Primary completion: Mar 14, 2018
Completion: Apr 19, 2018
Results posted: Jul 5, 2019
Last update: Jul 5, 2019

Study contacts

Medical Director

study director · Takeda

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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