A Multi-centric, Randomized, Comparative Clinical Trial to Evaluate the Efficacy and Safety of Lafutidine versus Rabeprazole in the Treatment of heartburn-dominant uninvestigated dyspepsia.

Zuventus Healthcare Ltd0 sites202 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

December 4, 2009

Last Updated

4 years ago

Study Type

Interventional

Sponsor

•Patients aged 18 years or older were eligible
•if they had a minimum of 1\-month history of dyspepsia (including symptoms of heartburn and/or epigastric pain and/or bloating) with at least one moderate\-to\-severe symptom (score \>\=4 on a 7\-point global overall symptom (GOS) scale) on at least three of the 7 days before randomization. Patients willing to give written informed consent and willing to comply with trial protocol

•1\. Patients showing alarm features (unintentional weight loss, persistent vomiting, dysphagia, haematemesis, melaena, fever, jaundice, or anaemia), irritable bowel syndrome or serious concomitant disease.
•2\. Patients with a history of gastrointestinal disease (including peptic ulcers, malignancy, oesophageal dysmotility and a previous endoscopic or radiological diagnosis of GERD and Barrett's oesophagus), recent gastrointestinal surgery i.e. within 30 days (except appendectomy, colonic resection and cholecystectomy).
•3\. Patients who had been treated with NSAIDs, ASA (\>325 mg/day), H2\-RAs, PPIs, prokinetic agents, misoprostol or sucralfate 15 days prior to enrollment.
•4\. Patients who had previously been included or who had participated in any other clinical trial within the last month.
•5\. Patients with a known history of hypersensitivity to study medications.
•6\. Patients who are pregnant, possibly pregnant, lactating, or who desire to become pregnant during the study.
•7\. Patients who are drug or alcohol abusers or suffering from any other condition associated with poor compliance.