The purpose of this study is to evaluate the effectiveness of symptom control in gastroesophageal reflux disease (GERD) participants following treatment with dexlansoprazole.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
296
Dexlansoprazole capsules
Unnamed facility
Shatin, New Territories, Hong Kong
Unnamed facility
Gyeonggi-do, South Korea
Unnamed facility
Gyeonggi-do, South Korea
Unnamed facility
Seoul, South Korea
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.
Time frame: 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.
Time frame: Up to Week 8
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.
Time frame: Up to 4 weeks for NERD participants and up to 8 weeks for EE participants
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.
Time frame: 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
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.
Time frame: Up to 4 weeks for NERD participants and up to 8 weeks for EE participants
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Unnamed facility
Seoul, South Korea
Unnamed facility
Kaoshiung, Taiwan
Unnamed facility
Taichung, Taiwan
Unnamed facility
Tainan, Taiwan
Unnamed facility
Taipei, Taiwan
Unnamed facility
Taoyuan, Taiwan
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.
Time frame: 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
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.
Time frame: Up to 4 weeks for NERD participants and up to 8 weeks for EE participants
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).
Time frame: Up to 4 weeks for NERD participants and up to 8 weeks for EE participants
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.
Time frame: Week 8