Treatment Effect Between Dexlansoprazole and Double-dose Lansoprazole in Obesity Patients With Reflux Esophagitis

NCT02759393 | Unknown Phase 4 DMC

• 1 other identifier: MOHW104-TDU-B-2111-113002
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to investigate whether dexlansoprazole can be as effective as double dose PPI to achieve SSR in high BMI cases with reflux esophagitis in Los Angeles grades A \& B.

Conditions

Gastroesophageal Reflux Disease

Outcome Measures

Primary Outcomes (1)

• the rate of sustained symptomatic response (SSR)

  8 weeks

Study Arms (2)

DEX group

EXPERIMENTAL

receiving 8-week dexlansoprazole 60 mg per day

Drug: Dexlansoprazole

Double-dose PPI group

ACTIVE COMPARATOR

receiving 8-week lansoprazole 30 mg twice daily

Drug: Lansoprazole

Interventions

Dexlansoprazole DRUG

receiving 8-week PPI

DEX group

Lansoprazole DRUG

receiving 8-week PPI

Double-dose PPI group

Eligibility Criteria

• Age: 20 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible participants included patients ≥20 years with either overweight (BMI of 25-30 kg/m2) or obese (BMI \> 30 kg/m2), who had undergone panendoscopy due to typical clinical symptoms of either acid regurgitation, heartburn sensation, or both. By the results of panendoscopy, patients with the severity of grade A or B esophageal reflux, according to the Los Angeles classification, are enrolled.

You may not qualify if:

• Patients are excluded if they have taken antisecretory agents, including histamine-2 receptor antagonist and PPI, within two weeks prior to the panendoscopy. The following conditions are also excluded: the presence of peptic ulcers, pregnancy, major medical problems (including hypertension, liver cirrhosis, COPD, asthma, renal failure and congestive heart failure), or previous gastric surgery. Patients who have an allergy history to dexlansoprazole or lansoprazole are also excluded.

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Related Publications (8)

• Jacobson BC, Somers SC, Fuchs CS, Kelly CP, Camargo CA Jr. Body-mass index and symptoms of gastroesophageal reflux in women. N Engl J Med. 2006 Jun 1;354(22):2340-8. doi: 10.1056/NEJMoa054391.

  PMID: 16738270 BACKGROUND

• Hampel H, Abraham NS, El-Serag HB. Meta-analysis: obesity and the risk for gastroesophageal reflux disease and its complications. Ann Intern Med. 2005 Aug 2;143(3):199-211. doi: 10.7326/0003-4819-143-3-200508020-00006.

  PMID: 16061918 BACKGROUND

• Sheu BS, Cheng HC, Chang WL, Chen WY, Kao AW. The impact of body mass index on the application of on-demand therapy for Los Angeles grades A and B reflux esophagitis. Am J Gastroenterol. 2007 Nov;102(11):2387-94. doi: 10.1111/j.1572-0241.2007.01468.x.

  PMID: 17850409 BACKGROUND

• Chen WY, Chang WL, Tsai YC, Cheng HC, Lu CC, Sheu BS. Double-dosed pantoprazole accelerates the sustained symptomatic response in overweight and obese patients with reflux esophagitis in Los Angeles grades A and B. Am J Gastroenterol. 2010 May;105(5):1046-52. doi: 10.1038/ajg.2009.632. Epub 2009 Nov 10.

  PMID: 19904250 BACKGROUND

• Peura DA, Pilmer B, Hunt B, Mody R, Perez MC. Distinguishing the impact of dexlansoprazole on heartburn vs. regurgitation in patients with gastro-oesophageal reflux disease. Aliment Pharmacol Ther. 2013 Nov;38(10):1303-11. doi: 10.1111/apt.12504. Epub 2013 Sep 30.

  PMID: 24118079 BACKGROUND

• Peura DA, Pilmer B, Hunt B, Mody R, Perez MC. The effects of increasing body mass index on heartburn severity, frequency and response to treatment with dexlansoprazole or lansoprazole. Aliment Pharmacol Ther. 2013 Apr;37(8):810-8. doi: 10.1111/apt.12270. Epub 2013 Mar 4.

  PMID: 23451835 BACKGROUND

• de Morais SM, Wilkinson GR, Blaisdell J, Nakamura K, Meyer UA, Goldstein JA. The major genetic defect responsible for the polymorphism of S-mephenytoin metabolism in humans. J Biol Chem. 1994 Jun 3;269(22):15419-22.

  PMID: 8195181 BACKGROUND

• Sheu BS, Kao AW, Cheng HC, Hunag SF, Chen TW, Lu CC, Wu JJ. Esomeprazole 40 mg twice daily in triple therapy and the efficacy of Helicobacter pylori eradication related to CYP2C19 metabolism. Aliment Pharmacol Ther. 2005 Feb 1;21(3):283-8. doi: 10.1111/j.1365-2036.2005.02281.x.

  PMID: 15691303 BACKGROUND

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Dexlansoprazole; Lansoprazole

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Bor-Shyang Sheu, MD

  National Cheng-Kung University Hospital

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: April 29, 2016
• First Posted: May 3, 2016
• Study Start: October 1, 2015
• Primary Completion: July 1, 2017
• Study Completion: September 1, 2017
• Last Updated: May 3, 2016

Record last verified: 2016-04