The Effect of Lansoprazole in Combination With Ecabet Sodium for Gastroesophageal Reflux Disease

Overview

We will estimate the responses of lansoprazole and ecabet sodium combination therapy and compare with lansoprazole and placebo therapy in patients who need additional therapy after standard proton pump inhibitor treatment for 4week or more in recurrent gastroesophageal reflux disease.

Full Title of Study: “Randomized Controlled Trial to Evaluate the Effect of Lansoprazole in Combination With Ecabet Sodium for Gastroesophageal Reflux Disease”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: March 2011

Interventions

  • Drug: ecabet sodium
    • Active comparator group patients will take lansoprazole 15 mg once daily and ecabet sodium 1.0 g three times daily and placebo group patients will take lansoprazole 15 mg once daily and placebo 1.0 g three times daily for total 8 weeks.
  • Drug: lansoprazole
    • Active comparator group patients will take lansoprazole 15 mg once daily and ecabet sodium 1.0 g three times daily and placebo group patients will take lansoprazole 15 mg once daily and placebo 1.0 g three times daily for total 8 weeks.
  • Drug: placebo
    • Active comparator group patients will take lansoprazole 15 mg once daily and ecabet sodium 1.0 g three times daily and placebo group patients will take lansoprazole 15 mg once daily and placebo 1.0 g three times daily for total 8 weeks.

Arms, Groups and Cohorts

  • Active Comparator: lansoprazole + ecabet sodium
  • Placebo Comparator: lansoprazole + placebo

Clinical Trial Outcome Measures

Primary Measures

  • We will compare the summations of symptoms score and calculate the response rate
    • Time Frame: after 4 weeks and 8 weeks

Secondary Measures

  • the global response of treatment
    • Time Frame: after 8 weeks

Participating in This Clinical Trial

Inclusion Criteria

  • age 19-75 years – patients with typical gastroesophageal symptom or erosive reflux esophagitis on gastroduodenoscopy – patients with recurrent gastroesophageal symptom after standard proton pump inhibitor treatment for 4 weeks or more Exclusion Criteria:

  • patients with gastric ulcer or duodenal ulcer – patients with gastric cancer or esophageal cancer – pregnant or postpartum women

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Seoul National University Hospital
  • Provider of Information About this Clinical Study
    • Joo Sung Kim, Seoul National University Hospital
  • Overall Official(s)
    • Joo Sung Kim, M.D., PhD, Principal Investigator, Seoul National University Hospital

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