Health Condition 1: K30- Functional dyspepsia
Conditions
Interventions
Intervention1: Lafutidine: One Lafutidine (10 mg) tablet to be taken orally once daily for 28 days.
Control Intervention1: Rabeprazole.: One Rabeprazole (20 mg) tablet to be taken once daily for 28 da
Sponsors
Zuventus Healthcare Ltd
Emcure Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of the patients achieving a score of GOS â?¤ 2 for epigastric pain, heartburn, and abdominal bloating.Timepoint: After 2 & 4 weeks of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
India
Contacts
Public ContactDr Bhupesh Dewan
Zuventus Healthcare Ltd
Outcome results
None listed