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

Erosive Esophagitis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02873702
• Other study ID #: TAK-390MR_301
• Secondary ID: U1111-1142-0320
• Status: Terminated
• Phase: Phase 3
• Start date: December 21, 2016
• Est. completion date: November 6, 2017

Study information

• Verified date: October 2018
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 37
• Est. completion date: November 6, 2017
• Est. primary completion date: October 16, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

1. 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.

2. 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).

3. 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.

4. Has a known history or any suspicious Barrett's esophagus with dysplastic changes seen during screening endoscopy.

5. 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.

6. 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).

7. 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.

8. 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).

9. Has current Zollinger-Ellison syndrome (gastric acid hyper secretion) or a history of gastric acid hypersecretion.

10. Participant is scheduled for surgery that requires hospitalization or requires surgical treatment during his/her participation in the study.

11. 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.

12. Has a history of alcohol or drug abuse (defined as any illicit drug use), or drug addiction in the 12 months prior to Screening.

13. 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.

Related Conditions & MeSH terms

• Erosive Esophagitis
• Esophagitis

Intervention

Drug:
• Dexlansoprazole
Dexlansoprazole delayed-release capsules.
• Lansoprazole
Lansoprazole capsules.
• Placebo
Dexlansoprazole placebo-matching capsules.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing
China	Peking University First Hospital	Beijing	Beijing
China	Binzhou Medical University Hospital	Binzhou	Shandong
China	The Third Hospital of Changsha	Chang Sha	Hu Nan
China	The First Hospital of Jilin University	Changchun	Jilin
China	West China Hospital,Sichuan University	Cheng Du	Si Chuang
China	Chongqing Three Gorges Central Hospital	Chong Qing	Chong Qing
China	Affilicated Hospital of Guilin Medical University	Hai Kou	Gui Lin
China	Jinan Central Hospital	Jinan	Shandong
China	Liaocheng Hospital	Liaocheng	Shandong
China	Zhongda Hospital Southeast	Nan Jing	Jiang Su
China	The People's Hospital of Guangxi Zhuang Autonomous Region	Nan Ning	Guang XI
China	The Affiliated Hospital of Qingdao University	Qingdao	Shandong
China	Renji Hospital Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai
China	Shengjing Hospital of China Medical University	Shenyang	Liaoning
China	Taihe Hospital	Shi Yan	Hu Bei
China	Hebei General Hospital	Shijiazhuang	Hebei
China	The First Hospital of Shanxi Medical University	Taiyuan	Shanxi
China	The Second Hospital of Shanxi Medical University	Taiyuan	Shanxi
China	Tianjin People's Hospital	Tianjin	Tianjin
China	Affiliated Hospital of Jiangsu University	Wu XI	Jiang Su
China	Wuxi people's hospital	Wu XI	Jiang Su
China	Central Hospital of Wuhan	Wuhan	Hu Bei
China	Puai Hospital Of Wuhan City	Wuhan	Hu Bei
China	Zhongshan Hospital Xiamen University	Xia Men	Fu Jian

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Week 8
Secondary	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.	Month 6

External Links

•   Dexlansoprazole Package Insert