Dexlansoprazole in Asian Participants With Gastroesophageal Reflux Disease

Gastroesophageal Reflux Disease Clinical Trial

Official title:

A Phase 4, Open-Label Study in Patients From Asia With Gastroesophageal Reflux Disease Treated With Dexlansoprazole

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02351960
• Other study ID #: DEX-P4-001
• Secondary ID: U1111-1155-8622
• Status: Completed
• Phase: Phase 4
• First received: January 27, 2015
• Last updated: May 12, 2017
• Start date: March 19, 2015
• Est. completion date: July 13, 2016

Study information

• Verified date: May 2017
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effectiveness of symptom control in gastroesophageal reflux disease (GERD) participants following treatment with dexlansoprazole.

Description:

The drug being tested in this study is called dexlansoprazole. A dual delayed release formulation of dexlansoprazole, referred to as dexlansoprazole modified release (dexlansoprazole MR) was tested to treat people who have gastroesophageal reflux disease (GERD). This study looked at the healing of the esophageal lining of the GERD participants who took dexlansoprazole MR.

The study enrolled 296 patients. Participants were assigned to two study groups based on the endoscopy screening procedures to receive treatments as follows:

• Dexlansoprazole 30 mg to participants with non-erosive reflux disease (NERD)

• Dexlansoprazole 60 mg to participants with erosive esophagitis (EE)

All participants were asked to take one capsule in the morning each day throughout the study. All participants were asked to record the presence and maximum severity of daytime and nighttime heartburn and regurgitation symptoms during screening and, if assigned to a treatment group, throughout the duration of the study using the supplied paper diary.

This multi-center trial was conducted in Asia (Hong Kong, Taiwan, South Korea). The overall time to participate in this study was up to 8 weeks. Participants would make up to 3 visits to the clinic, and would be contacted by telephone 30 days after the last dose of study drug for a follow-up assessment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 296
• Est. completion date: July 13, 2016
• Est. primary completion date: June 22, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria: -

1. In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements

2. The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any procedures

3. Has persistent typical gastroesophageal reflux disease (GERD) symptoms (heartburn and/or acid regurgitation) for at least 6 months and a frequency of GERD symptoms is at least 4 days within the past 7 days prior to the screening visit

4. Meets one of the following diagnoses verified by the screening endoscopy

1. Has macroscopically normal esophageal mucosa on endoscopy and may thereby be eligible for assignment to the nonerosive reflux disease (NERD) study group

2. Has evidence of erosive esophageal reflux disease on endoscopy, Los Angeles (LA) classification grades B-D, and thereby may be eligible for assignment to the erosive esophagitis (EE) study group

5. Is able and willing to record GERD symptoms in a subject diary and has completed the diary at least for 7 consecutive days during the screening period

6. Male participant who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 30 days after last dose

7. A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of informed consent throughout the duration of the study

8. All female participants of childbearing potential must have a negative urine pregnancy test at Screening and a negative urine pregnancy test at Day -1. Participants who have had a bilateral tubal ligation, hysterectomy or are post-menopausal (the absence of menses for 1-2 years with a Follicle-Stimulating Hormone [FSH] level >40 IU/L or absence of menses for >2 years) are not required to use birth control

Exclusion Criteria:

1. Has received any investigational compound within 30 days prior to Screening

2. Known hypersensitivity to any proton pump inhibitor (including lansoprazole, omeprazole, rabeprazole, pantoprazole or esomeprazole), any component of dexlansoprazole

3. Use of a H2 blocker or a PPI other than dexlansoprazole during screening and throughout the study. Previous use of Dexlansoprazole before screening

4. Endoscopic Barrett's esophagus and/or definite dysplastic changes in the esophagus

5. Active gastric or duodenal ulcers within 4 weeks of the first dose of study drug

6. History of dilatation of esophageal strictures, other than a Schatzki's ring (a ring of mucosal tissue near the lower esophageal sphincter)

7. Co-existing diseases affecting the esophagus, (eg, esophageal varices, scleroderma, viral, fungal infection or esophageal stricture), history of radiation therapy or cryotherapy to the esophagus, caustic or physiochemical trauma such as sclerotherapy to the esophagus

8. Chronic use (>12 doses/month) of non-;steroidal anti-inflammatory drugs (NSAIDs) including COX 2 NSAIDs within 30 days prior to screening period and throughout the study, however, low dose aspirin up to 325 mg per day is allowed

9. In the judgment of the investigator, participant has clinically significant abnormal hematological parameters of hemoglobin, hematocrit, or erythrocytes at Screening

10. Has a history or clinical manifestations of significant organ failure which would preclude their successful completion of the study

11. Participants using drugs with significant anticholinergic effects such as tricyclics who cannot stay on a stable dose for 4 weeks prior to dosing and throughout the study

12. Participants with known biliary disease

13. Participants with the need for continuous anticoagulant therapy

14. Participants with cancer (except basal cell and squamous cell carcinoma of the skin) within 3 years prior to Screening

15. Any condition that may require inpatient surgery during the course of the study

16. Has abnormal laboratory values that suggest a clinically significant underlying disease or condition that may prevent the subject from entering the study; or subject with the following lab abnormalities: Creatinine >1.5 mg/dL, Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) >2.0X the upper limits of normal, or Total Bilirubin >2.0 mg/dL with AST/ALT elevated above normal values

17. Known to have acquired immunodeficiency syndrome (AIDS)

18. Current or historical evidence of Zollinger-Ellison syndrome or other hypersecretory condition

19. History of gastric, duodenal or esophageal surgery except simple oversew of an ulcer

20. Acute upper gastrointestinal (UGI) hemorrhage within 4 weeks of endoscopy

22. Has received blood products within 3 months prior to the first dose of study drug 23. History of alcohol abuse [>21 units (1 unit = 12 oz beer, 1.5 oz hard liquor, or 5 oz wine) per week] or illegal drug use or drug addiction in the 12 months prior to Screening 24. Participants who, in the opinion of the investigator, are unable to comply with the requirements of the study or are unsuitable for any reason 25. is required to take excluded medications 26. If female, the participant is pregnant or lactating or intending to become pregnant before, during, or within 1 month after participating in this study; or intending to donate ova during such time period 27. If male, the participant intends to donate sperm during the course of this study or for 30 days thereafter

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

Drug:
• Dexlansoprazole
Dexlansoprazole capsules

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Countries where clinical trial is conducted

Hong Kong,  Korea, Republic of,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of 24-Hour Heartburn and Acid Regurgitation-Free Days in Non-Erosive Reflux Disease (NERD) Participants	NERD participants were asked to keep a paper diary of daily heartburn and acid regurgitation-free days and the percentage of heartburn and acid regurgitation-free days was recorded.	Up to Week 4
Primary	Percentage of 24-Hour Heartburn and Acid Regurgitation-Free Days in Erosive Esophagitis (EE) Participants	EE participants were asked to keep a paper diary of daily heartburn and acid regurgitation-free days and the percentage of heartburn and acid regurgitation-free days was calculated.	Up to Week 8
Secondary	Percentage of 24-hour Heartburn-free Days	Participants were asked to keep a daily paper diary. The percentage of 24-hour heartburn free days following study drug treatments was assessed by the participant diary entries.	Up to 4 weeks for NERD participants and up to 8 weeks for EE participants
Secondary	Percentage of 24-hour Acid Regurgitation-free Days	Participants were asked to keep a daily paper diary. The percentage of 24-hour acid regurgitation-free days following study drug treatments was assessed by participant's diary entries.	Up to 4 weeks for NERD participants and up to 8 weeks for EE participants
Secondary	Percentage of Nights (Participant Sleep Time) Without Nighttime Heartburn and Acid Regurgitation	Participants were asked to keep a daily paper diary. The percentage of nights without nighttime heartburn and acid regurgitation in both the group was assessed by participant dairy entries.	Up to 4 weeks for NERD participants and up to 8 weeks for EE participants
Secondary	Percentage of Nights (Participant Sleep Time) Without Nighttime Heartburn	Participants were asked to keep a daily paper diary. The percentage of nights without nighttime heartburn in both the group was assessed by participant diary entries.	Up to 4 weeks for NERD participants and up to 8 weeks for EE participants
Secondary	Percentage of Nights (Participant Sleep Time) Without Nighttime Acid Regurgitation	Participants were asked to keep a daily paper diary. The percentage of nights without nighttime acid regurgitation in both the group was assessed by participant diary entries.	Up to 4 weeks for NERD participants and up to 8 weeks for EE participants
Secondary	Number of Participants With Severity of Gastroesophageal Reflux Disease (GERD) Symptoms	The severity of participants' GERD symptoms based on the investigator's assessment among all participants was evaluated at Week 4 or Week 8. GERD symptoms were assessed on a 5-point scale, wherein 1=no symptom, 2=mild, 3=moderate, 4=severe and 5=very severe. GERD symptoms include heartburn (HB), acid regurgitation (AR), dysphagia (dysp), belching (bch) and epigastric pain (EP).	Up to 4 weeks for NERD participants and up to 8 weeks for EE participants
Secondary	Percentage of Participants in the EE Group Who Had Endoscopically Evaluated Macroscopic Healing of Their Esophagus	Participants underwent endoscopy to determine the percentage of participants with macroscopic healing of their esophagus showing at least 1 Los Angeles (LA) grade classification grade improvement at week 8. Endoscopic findings classified according to the Los Angeles classification: Grade Normal - endoscopy reveals no mucosal break Grade A- one or more mucosal breaks <5 mm in maximal length Grade B - one or more mucosal breaks >5 mm, but without continuity across mucosal folds Grade C - Mucosal breaks continuous between >2 mucosal folds, but involving less than 75% of the esophageal circumference Grade D - Mucosal breaks involving more than 75% of the esophageal circumference.	Week 8