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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01039558

Enrollment

Registered

2009-12-25

Start date

2009-12-31

Completion date

2011-03-31

Last updated

2011-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroesophageal Reflux Disease

Keywords

gastroesophageal reflux disease, lansoprazole, ecabet sodium

Brief summary

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.

Interventions

DRUGecabet 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.

DRUGlansoprazole

DRUGplacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

19 Years to 75 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
We will compare the summations of symptoms score and calculate the response rate	after 4 weeks and 8 weeks

Secondary

Measure	Time frame
the global response of treatment	after 8 weeks

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026