Clinical trial NCT00847808: Efficacy of Dexlansoprazole MR on Heartburn Control in Participants Previously Receiving Twice Daily Proton Pump Inhibitor Therapy
Official title: A Phase 3b Multicenter, Single-Blind Trial to Evaluate the Efficacy of Dexlansoprazole MR 30 mg in Maintaining Control of Gastroesophageal Reflux Disease Symptoms in Subjects on Prior Twice Daily Proton Pump Inhibitor Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastroesophageal Reflux
Keywords: Esophageal Reflux
Gastro-Esophageal Reflux
Gastroesophageal Reflux Disease
GERD
Regurgitation, Gastric
Heartburn
Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2009-02-19
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if patients with well-controlled heartburn symptoms on twice-daily proton pump inhibitor therapy remain well-controlled after stepping down to once-daily (QD) dexlansoprazole modified release (MR) 30 mg.

Detailed description: Gastroesophageal reflux disease is recognized as a common and persistent medical problem in the US adult population. Gastroesophageal reflux disease comprises a spectrum of acid-related disorders including symptomatic nonerosive gastroesophageal reflux disease and erosive esophagitis. It affects men and women in nearly equal proportions, and the severity and intensity of heartburn symptoms may be similar in both types of patients.

Dexlansoprazole modified release is a dual delayed release formulation that consists of two types of granules contained in a single capsule. This dual delayed release formulation is designed to extend the duration of drug exposure and maintain pharmacologically active levels over a longer time period.

The purpose of this study is to demonstrate that participants with gastroesophageal reflux disease whose symptoms are well-controlled on twice daily proton pump inhibitors, remain well-controlled when switched to dexlansoprazole MR.

Eligibility criteria: Inclusion Criteria:

1. Prior to any study-specific procedures being performed, the participant voluntarily signs an Investigational Review Board-approved informed consent form (ICF) and any privacy statement/authorization form required (eg, The Health Insurance Portability and Accountability Act (HIPAA) authorization)
2. Has a history of gastroesophageal reflux disease symptom, including heartburn, prior to therapy, who are currently being treated with twice daily proton pump inhibitors, excluding Dexilant (dexlansoprazole).
3. Taking a stable dose of any twice daily proton pump inhibitors for less than or equal to 1 year and greater than 8 weeks prior to Screening.
4. Participant is well-controlled on their current twice daily proton pump inhibitors.
5. Females cannot be nursing and must have a negative urine pregnancy test at Day -1 or be of non-childbearing potential. If females are of child bearing potential, must have a negative serum human chorionic gonadotropin (hCG) pregnancy test during Screening and on an acceptable form of contraception, or have had bilateral tubal ligation if performed a minimum of 90 days prior to Day 1.

Exclusion Criteria:

1. Has a history of co-existing diseases affecting the esophagus, history of radiation therapy or cryotherapy to the esophagus, caustic or physiochemical trauma such as sclerotherapy to the esophagus.
2. Has active gastric or duodenal ulcers during the 30 days prior to Screening.
3. Has acute upper gastrointestinal hemorrhage during the 30 days prior to Screening.
4. Has current or historical evidence of Zollinger-Ellison syndrome or other hypersecretory condition.
5. Has known hypersensitivity to any proton pump inhibitor or any component of dexlansoprazole MR.
6. Use of any Histamine type-2 receptor antagonist or antacids during Screening or anticipated use during the study treatment period.
7. Use of the following medications 7 days prior to Screening or anticipated use during the study:

   * Sucralfate.
   * Misoprostol.
   * Systemic corticosteroids.
   * Prokinetics (to include metoclopramide, cisapride, tegaserod).
   * Bisphosphonates during the 6 months prior to Screening or anticipated use during the study.
   * Chronic use (\> 12 doses per month) of nonsteroidal anti-inflammatory drugs
   * Drugs with significant anticholinergic effects such as tricyclic antidepressants or drugs with central nervous system effects that could mask perception of symptoms.
   * Any investigational drug(s) within 30 days of Screening.
8. Has received blood products within the 3 months prior to Screening.
9. History of alcohol abuse or illegal drug use or drug addiction in the 12 months prior to Screening.
10. Evidence of uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other abnormality, which may impact the ability of the participant to participate or potentially confound the study results.
11. Atypical manifestations of gastroesophageal reflux disease.
12. Has abnormal screening laboratory values that suggest a clinically significant underlying disease or condition.
13. Cancer within 5 years prior to Screening.
14. Is known to have acquired immunodeficiency syndrome.
15. Has any condition that is likely to require inpatient surgery during the course of the study.
16. Surgery of the acute upper gastrointestinal tract, including bariatric.
17. Is in the opinion of the investigator unable to comply with the requirements of the study or are unsuitable for any reason.

Primary outcomes:
measure: Proportion of Participants Who Remain Well Controlled After Switching From Their Current Twice-daily Proton Pump Inhibitor Therapy to Dexlansoprazole MR.
timeFrame: Week 3 through Week 6
Secondary outcomes:
measure: Change From Baseline in the Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life (PAGI-QOL) - Daily Activities Subscale in Participants Who Remain Well-controlled.
timeFrame: Baseline and Week 6.
measure: Change From Baseline in the Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life (PAGI-QOL) - Clothing Subscale in Participants Who Remain Well-controlled.
timeFrame: Baseline and Week 6.
measure: Change From Baseline in the Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life (PAGI-QOL) - Diet and Food Habits Subscale in Participants Who Remain Well-controlled.
timeFrame: Baseline and Week 6.
measure: Change From Baseline in the Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life (PAGI-QOL) - Relationship Subscale in Participants Who Remain Well-controlled.
timeFrame: Baseline and Week 6.
measure: Change From Baseline in the Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life (PAGI-QOL) - Psychological Well-being Subscale in Participants Who Remain Well-controlled.
timeFrame: Baseline and Week 6.
measure: Change From Baseline in the Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life (PAGI-QOL) - Total Score in Participants Who Remain Well-controlled.
timeFrame: Baseline and Week 6.
measure: Change From Baseline in Patient Assessment of Upper Gastrointestinal Disorders - Symptom Severity Index (PAGI-SYM) - Nausea/Vomiting Subscale in Participants Who Remain Well-controlled.
timeFrame: Baseline and Week 6.
measure: Change From Baseline in Patient Assessment of Upper Gastrointestinal Disorders - Symptom Severity Index (PAGI-SYM) - Fullness/Early Satiety Subscale in Participants Who Remain Well-controlled.
timeFrame: Baseline and Week 6.
measure: Change From Baseline in Patient Assessment of Upper Gastrointestinal Disorders - Symptom Severity Index (PAGI-SYM) - Bloating Subscale in Participants Who Remain Well-controlled.
timeFrame: Baseline and Week 6.
measure: Change From Baseline in Patient Assessment of Upper Gastrointestinal Disorders - Symptom Severity Index (PAGI-SYM) - Upper Abdominal Pain Subscale in Participants Who Remain Well-controlled.
timeFrame: Baseline and Week 6.
measure: Change From Baseline in Patient Assessment of Upper Gastrointestinal Disorders - Symptom Severity Index (PAGI-SYM) - Lower Abdominal Pain Subscale in Participants Who Remain Well-controlled.
timeFrame: Baseline and Week 6.
measure: Change From Baseline in Patient Assessment of Upper Gastrointestinal Disorders - Symptom Severity Index (PAGI-SYM) - Heartburn/Regurgitation Subscale in Participants Who Remain Well-controlled.
timeFrame: Baseline and Week 6.
measure: Change From Baseline in Patient Assessment of Upper Gastrointestinal Disorders - Symptom Severity Index (PAGI-SYM) - Total Score in Participants Who Remain Well-controlled.
timeFrame: Baseline and Week 6.
Other outcomes:
Locations:
city: Hueytown
country: United States
state: Alabama
city: Chandler
country: United States
state: Arizona
city: Sierra Vista
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Sherman
country: United States
state: Arkansas
city: Sherwood
country: United States
state: Arkansas
city: Carmichael
country: United States
state: California
city: Garden Grove
country: United States
state: California
city: Laguna Hills
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Paramount
country: United States
state: California
city: Rancho Cucamonga
country: United States
state: California
city: Roseville
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Ramon
country: United States
state: California
city: Tustin
country: United States
state: California
city: Westlake Village
country: United States
state: California
city: Bristol
country: United States
state: Connecticut
city: Boynton Beach
country: United States
state: Florida
city: Hialeah
country: United States
state: Florida
city: New Smyrna Beach
country: United States
state: Florida
city: Winter Haven
country: United States
state: Florida
city: Augusta
country: United States
state: Georgia
city: Conyers
country: United States
state: Georgia
city: Newman
country: United States
state: Georgia
city: Stockbridge
country: United States
state: Georgia
city: Rockford
country: United States
state: Illinois
city: Metairie
country: United States
state: Louisiana
city: Prince Frederick
country: United States
state: Maryland
city: Stevensville
country: United States
state: Michigan
city: Olive Branch
country: United States
state: Mississippi
city: Egg Harbor Township
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: Rochester
country: United States
state: New York
city: Wilmington
country: United States
state: North Carolina
city: Columbus
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Yukon
country: United States
state: Oklahoma
city: Portland
country: United States
state: Oregon
city: Lansdale
country: United States
state: Pennsylvania
city: Salisbury
country: United States
state: South Carolina
city: Chattanooga
country: United States
state: Tennessee
city: Johnson City
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: El Paso
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: South Ogden
country: United States
state: Utah
city: Chesapeake
country: United States
state: Virginia
city: Norfolk
country: United States
state: Virginia
city: Lakewood
country: United States
state: Washington
Study officials:
affiliation: Takeda
name: Medical Director Clinical Science
role: STUDY_DIRECTOR
References:
citation: Fass R, Inadomi J, Han C, Mody R, O'Neil J, Perez MC. Maintenance of heartburn relief after step-down from twice-daily proton pump inhibitor to once-daily dexlansoprazole modified release. Clin Gastroenterol Hepatol. 2012 Mar;10(3):247-53. doi: 10.1016/j.cgh.2011.11.021. Epub 2011 Dec 7.