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Completed

NCT Number: NCT01039558

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

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.

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Key information

Conditions

Gastroesophageal Reflux Disease Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ecabet sodium

Drug

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.

Other names: Gastrex ganules

Lansoprazole

Drug

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.

Placebo

Drug

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.

Primary outcomes

  1. We will compare the summations of symptoms score and calculate the response rate

    Time frame: after 4 weeks and 8 weeks

Secondary outcomes

  1. the global response of treatment

    Time frame: after 8 weeks

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Randomized Controlled Trial to Evaluate the Effect of Lansoprazole in Combination With Ecabet Sodium for Gastroesophageal Reflux Disease

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Dec 25, 2009
Registry last updated
Jul 28, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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