Dexlansoprazole in Asian Participants With Gastroesophageal Reflux Disease

NCT02351960 | Completed Phase 4 Results

• 2 other identifiers: DEX-P4-001U1111-1155-8622
• Study Type: interventional
• Target: 296
• Locations: 3 countries
• Sites: 10

Brief Summary

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

Conditions

Gastroesophageal Reflux Disease

Keywords

Drug therapy; GERD; Dexlansoprazole

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (7)

• Percentage of 24-hour Heartburn-free Days

  Up to 4 weeks for NERD participants and up to 8 weeks for EE participants

• Percentage of 24-hour Acid Regurgitation-free Days

  Up to 4 weeks for NERD participants and up to 8 weeks for EE participants

• Percentage of Nights (Participant Sleep Time) Without Nighttime Heartburn and Acid Regurgitation

  Up to 4 weeks for NERD participants and up to 8 weeks for EE participants

• Percentage of Nights (Participant Sleep Time) Without Nighttime Heartburn

  Up to 4 weeks for NERD participants and up to 8 weeks for EE participants

• Percentage of Nights (Participant Sleep Time) Without Nighttime Acid Regurgitation

  Up to 4 weeks for NERD participants and up to 8 weeks for EE participants

Study Arms (2)

Dexlansoprazole 30 mg

EXPERIMENTAL

Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks to participants with non-erosive reflux disease (NERD).

Drug: Dexlansoprazole

Dexlansoprazole 60 mg

EXPERIMENTAL

Dexlansoprazole 60 mg, capsules orally, once daily for up to 8 weeks to participants with erosive esophagitis (EE).

Drug: Dexlansoprazole

Interventions

Dexlansoprazole DRUG

Dexlansoprazole capsules

Dexlansoprazole 30 mg; Dexlansoprazole 60 mg

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements
• 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
• 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
• Meets one of the following diagnoses verified by the screening endoscopy
• Has macroscopically normal esophageal mucosa on endoscopy and may thereby be eligible for assignment to the nonerosive reflux disease (NERD) study group
• 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
• 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
• 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
• 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
• 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

You may not qualify if:

• Has received any investigational compound within 30 days prior to Screening
• Known hypersensitivity to any proton pump inhibitor (including lansoprazole, omeprazole, rabeprazole, pantoprazole or esomeprazole), any component of dexlansoprazole
• Use of a H2 blocker or a PPI other than dexlansoprazole during screening and throughout the study. Previous use of Dexlansoprazole before screening
• Endoscopic Barrett's esophagus and/or definite dysplastic changes in the esophagus
• Active gastric or duodenal ulcers within 4 weeks of the first dose of study drug
• History of dilatation of esophageal strictures, other than a Schatzki's ring (a ring of mucosal tissue near the lower esophageal sphincter)
• 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
• 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
• In the judgment of the investigator, participant has clinically significant abnormal hematological parameters of hemoglobin, hematocrit, or erythrocytes at Screening
• Has a history or clinical manifestations of significant organ failure which would preclude their successful completion of the study
• 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
• Participants with known biliary disease
• Participants with the need for continuous anticoagulant therapy
• Participants with cancer (except basal cell and squamous cell carcinoma of the skin) within 3 years prior to Screening
• Any condition that may require inpatient surgery during the course of the study

Sponsors & Collaborators

• Takeda: lead

Study Sites (10)

Unknown Facility

Shatin, New Territories, Hong Kong

Location

Unknown Facility

Gyeonggi-do, 463-707, South Korea

Location

Unknown Facility

Gyeonggi-do, South Korea

Location

Unknown Facility

Seoul, 137-701, South Korea

Location

Unknown Facility

Seoul, South Korea

Location

Unknown Facility

Kaoshiung, Taiwan

Location

Unknown Facility

Taichung, Taiwan

Location

Unknown Facility

Tainan, Taiwan

Location

Unknown Facility

Taipei, Taiwan

Location

Unknown Facility

Taoyuan District, Taiwan

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Dexlansoprazole

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Lansoprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2015
• First Posted: January 30, 2015
• Study Start: March 19, 2015
• Primary Completion: June 22, 2016
• Study Completion: July 13, 2016
• Last Updated: October 4, 2017
• Results First Posted: October 4, 2017

Record last verified: 2017-05

Locations

HK (1); KR (4); TW (5)