A clinical trial to study the effects of two drugs, Lafutidine and Rabeprazole in the Treatment of heartburn-dominant uninvestigated dyspepsia.
- Conditions
- Health Condition 1: K30- Functional dyspepsia
- Registration Number
- CTRI/2009/091/000913
- Lead Sponsor
- Zuventus Healthcare Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 202
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of the patients achieving a score of GOS â?¤ 2 for epigastric pain, <br/ ><br>heartburn, and abdominal bloating.Timepoint: After 2 & 4 weeks of treatment.
- Secondary Outcome Measures
Name Time Method Overall Patient Satisfaction: Defined As A Score Of 3 Or Less.Timepoint: After 4 Weeks Of Treatment;Patient Perspective On Symptom Relief: Defined As A Score Of 4 or moreTimepoint: After 2 & 4 Weeks Of Treatment;Proportion of the patients achieving symptom resolution [GOS score 1]Timepoint: After 2 and 4 weeks of treatment.;Symptom Improvement [difference of GOS Score: 2 or more]Timepoint: after 2 & 4 weeks of treatment.<br>