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Erosive EsophagitisPhase 3NCT02873702

Efficacy and Safety of Dexlansoprazole in Healing and Maintaining Healing of Erosive Esophagitis

A Phase 3 study testing Dexlansoprazole and Lansoprazole in people with Erosive Esophagitis, run by Takeda at 25 sites in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to determine the efficacy of dexlansoprazole compared to lansoprazole in healing erosive esophagitis (EE) in Chinese participants. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Erosive Esophagitis
What is being tested?
Dexlansoprazole and Lansoprazole
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
37 participants
Where
25 sitesChina
Study dates
21 Dec 2016to 6 Nov 2017
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

  • 1. Has endoscopically confirmed EE as defined by the LA Classification Grading System (A-D).

Who cannot join

  • Participant is required to take excluded medications, or it is anticipated that the participant will require treatment with at least 1 of the disallowed concomitant medications during the study evaluation period.
  • Has a hypersensitivity to any proton pump inhibitor (PPI) (including, but not limited to, lansoprazole, omeprazole, rabeprazole, pantoprazole, esomeprazole or ilaprazole), any component of dexlansoprazole, or antacid (example, magnesium trisilicate or similar antacid).
  • Had 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 or any suspicious Barrett's esophagus with dysplastic changes seen during screening endoscopy.
  • 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 (>12 doses per month) of non steroidal 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).
Show all 13Show fewer
  • 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.
  • Participant is known to have the 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 Zollinger-Ellison syndrome (gastric acid hyper secretion) or a history of gastric acid hypersecretion.
  • Participant 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 or drug abuse (defined as any illicit drug use), or drug addiction in the 12 months prior to Screening.
  • The 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

Other trials in China

About this study

Official title: A Phase 3 Study to Evaluate the Efficacy and Safety of Dexlansoprazole (60 mg QD) and an Active Comparator, Lansoprazole (30 mg QD) on Healing of Erosive Esophagitis, and Maintenance of Healing in Subjects With Healed Erosive Esophagitis With Dexlansoprazole (30 mg QD) and Placebo

The purpose of this study is to determine the efficacy of dexlansoprazole compared to lansoprazole in healing erosive esophagitis (EE) in Chinese participants.

Read the detailed description

The drug being tested in this study is called dexlansoprazole. Dexlansoprazole is being tested to treat people who have EE. This study will look at erosive esophageal healing in people who take dexlansoprazole.

The study will enroll approximately 450 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 60 mg
  • Lansoprazole 30 mg

After 8 weeks of treatment, participants will be evaluated to assess esophageal healing. If the EE is healed participants will be randomly assigned to one of two different treatment groups with 1:1 ratio:

  • 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.

This multi-center trial will be conducted in China. The overall time to participate in this study is up to 39 weeks. Participants will make 7 visits to the clinic, and will be contacted by telephone 5 to 10 days after last dose of study drug for a follow-up assessment.

Being tested
Dexlansoprazole, Lansoprazole, Placebo
Keywords
Drug therapy

What participants receive

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

  • DexlansoprazoleDrug

    Dexlansoprazole delayed-release capsules.

  • LansoprazoleDrug

    Lansoprazole capsules.

  • PlaceboDrug

    Dexlansoprazole placebo-matching capsules.

Study groups in NCT02873702
Study groupRoleWhat they receive
Healing Period: Dexlansoprazole 60 mgExperimentalDexlansoprazole 60 milligram (mg), delayed-release capsules, orally, once daily for up to 8 weeks in the Healing Period.
Receives: Drug: Dexlansoprazole
Healing Period: Lansoprazole 30 mgExperimentalLansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks in the Healing Period.
Receives: Drug: Lansoprazole
Maintenance Period: Dexlansprazole 30 mgExperimentalParticipants who will be healed at Week 8 will be randomized to receive dexlansoprazole 30 mg, delayed-release capsules, orally, once daily for up to 6 months in the Maintenance period.
Receives: Drug: Dexlansoprazole
Maintenance Period: PlaceboExperimentalParticipants who will be healed at Week 8 will be randomized to receive dexlansoprazole placebo-matching capsules, orally, once daily for up to 6 months in the Maintenance period.
Receives: Drug: Placebo

What is being measured

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

  1. Healing Period: Percentage of Participants With Complete Healing of EE at Week 8

    Percentage of participants with complete healing of EE was assessed by endoscopy. EE was graded according to the Los Angeles (LA) classification of esophagitis grading system, based on the extent of visible mucosal breaks seen in the esophagus according to the following: Grade O (no mucosal breaks); Grade A (>=1 mucosal break no longer than 5 millimeter [mm] that does not extend between the tops of 2 mucosal folds); Grade B (>=1 mucosal break greater than [>] 5 mm that does not extend between the tops of 2 mucosal folds); Grade C (>=1 mucosal break that is continuous between the tops of 2 or more mucosal folds, but involves <75 percent (%) of the circumference); Grade D (>=1 mucosal break which involves >=75% of the circumference). Healing is defined as LA Grade O.

    Measured: Week 8

Secondary outcomes (1)

  1. Maintenance Period: Percentage of Participants Who Maintained Complete Healing of EE at Month 6

    Percentage of participants with complete healing of EE was assessed by endoscopy. EE was graded according to the LA classification of esophagitis grading system, based on the extent of visible mucosal breaks seen in the esophagus according to the following: Grade O (no mucosal breaks); Grade A (>=1 mucosal break no longer than 5 mm that does not extend between the tops of 2 mucosal folds); Grade B (>=1 mucosal break >5 mm that does not extend between the tops of 2 mucosal folds); Grade C (>=1 mucosal break that is continuous between the tops of 2 or more mucosal folds, but involves <75% of the circumference); Grade D (>=1 mucosal break which involves >=75% of the circumference). Healing is defined as LA Grade O.

    Measured: Month 6

Timeline

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

  1. First posted19 Aug 2016 (estimated)
  2. Study start21 Dec 2016
  3. Primary completion16 Oct 2017
  4. Study completion6 Nov 2017

Why it stopped: Compound is not expected to change the current treatment practice or fill significant clinical need for patients in China over currently available EE agents.

Resources

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
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02873702
Sponsor's protocol ID
TAK-390MR_301
Other IDs
U1111-1142-0320
Status last verified
Oct 2018
First submitted
17 Aug 2016
Last updated
22 Feb 2019
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dexlansoprazole and Lansoprazole in people with Erosive Esophagitis, 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 1 inclusion and 13 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: stopped early, as of the sponsor's last update on 22 Feb 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 22 Feb 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?

Healing Period: Percentage of Participants With Complete Healing of EE at Week 8 (time frame: Week 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 NCT02873702.

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 22 Feb 2019.

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