Functioanl Dyspepsia
Conditions
Brief summary
The VIVA trial is a 12-week, randomized, interventional study comparing vonoprazan monotherapy versus vonoprazan plus itopride combination therapy in adults with functional dyspepsia (FD). FD is a common digestive disorder causing upper stomach discomfort, fullness after meals, and early satiety. The study aims to determine if adding itopride, a prokinetic that improves stomach emptying, to vonoprazan, a strong acid-suppressing drug, provides better symptom relief than vonoprazan alone. Participants will be randomly assigned to receive either treatment, and their symptoms, quality of life, and safety outcomes will be monitored throughout the study. The trial will help guide the best management strategy for FD by targeting both acid-related and motility-related symptoms.
Detailed description
Methodology Study Design:- The design compares vonoprazan 20mg monotherapy against vonoprazan 20mg + itopride 50mg (TID) combination therapy in a 1:1 allocation ratio. The total trial duration per participant is 12 weeks, consisting of a treatment period with regular follow-up assessments. The study's schematic is as follows: * Patients with dyspeptic symptoms will be screened for eligibility. This includes obtaining informed consent, recording medical history, confirming FD diagnosis (including verification of a normal endoscopy result and H. pylori status), and a washout from disallowed medications. Baseline symptom assessments and lab tests will be done at the end of this phase. * Randomization (Baseline) Visit: Eligible participants are randomly assigned to one of two treatment arms (described below) after baseline evaluations. Baseline symptom scores using Post prandial distress syndrome. * Assessment and follow up: Participants take the assigned study medications for 12 weeks. Follow-up telephone calls or visits are scheduled at regular intervals Week 4, Week 8 and physical visit at 12 weeks for monitoring and assessment. Methodology Study Design:- The design compares vonoprazan 20mg monotherapy against vonoprazan 20mg + itopride 50mg (TID) combination therapy in a 1:1 allocation ratio. The total trial duration per participant is 12 weeks, consisting of a treatment period with regular follow-up assessments. The study's schematic is as follows: * Patients with dyspeptic symptoms will be screened for eligibility. This includes obtaining informed consent, recording medical history, confirming FD diagnosis (including verification of a normal endoscopy result and H. pylori status), and a washout from disallowed medications. Baseline symptom assessments and lab tests will be done at the end of this phase. * Randomization (Baseline) Visit: Eligible participants are randomly assigned to one of two treatment arms (described below) after baseline evaluations. Baseline symptom scores using LPDS. * Assessment and follow up: Participants take the assigned study medications for 12 weeks. Follow-up telephone calls or visits are scheduled at regular intervals Week 4, Week 8 and physical visit at 12 weeks for monitoring and assessment.
Interventions
DRUGVonoprazan plus Itopride combination
Participants will receive vonoprazan 20 mg orally once daily (preferably in the morning) for 12 weeks, plus itopride 50 mg orally thrice daily before meals for 12 weeks. The vonoprazan dose of 20 mg daily is chosen as it is the standard dose shown to provide potent acid suppression
DRUGVonoprazan
Participants will receive vonoprazan 20 mg orally once daily for 12 weeks
Sponsors
Asian Institute of Gastroenterology, India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
1. Confirmed Functional Dyspepsia (FD): As per Rome IV criteria: Symptoms for ≥3 days/week over the last 3 months. 2. Prior endoscopy with normal findings or minor gastritis within the last 3 months. 3. Negative Helicobacter pylori test (Rapid urease test) or urea breath test 4. The patient should be off Proton pump inhibitors for 2 weeks
Exclusion criteria
1. Evidence of structural/biochemical issues like peptic ulcer, erosive esophagitis, gastric/esophageal malignancy, pancreato-biliary disorders Overlapping functional GI Disorders: IBS 2. Uncontrolled systemic diseases (e.g., uncontrolled diabetes), major psychiatric disorders (e.g., severe depression), or neurological disorders affecting Gastrointestinal motility. 3. Use of medications that affect gastrointestinal motility or symptom perception (e.g., chronic opioid analgesics, anticholinergic drugs, benzodiazepines). 4. Pregnancy or Lactation 5. History of Consumption of alcohol or smoking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Symptom Relief in Functional Dyspepsia | 12 weeks | Proportion of participants achieving significant improvement in dyspepsia symptoms, assessed by the Leeds Dyspepsia Questionnaire (LPDS) score -The scale range from 0 to 7 7 is the highest score of anxiety/ depression, 0 is the least score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life Improvement | 12 weeks | Change in Nepean Dyspepsia Index (NDI) scores , the scale range from 10 (Gastrointestinal symptoms effecting low level to the patient , 50 (Gastrointestinal symptoms affecting badly to the patinet) baseline to week 12. |
| Responder Rate | 12 weeks | Proportion of participants with ≥50% improvement in Leuven post prandial distress score (nausea, belching, heartbun scores questionares 4 indicates severe, 0 indicates no symtoms) |
| Safety and Tolerability | 12 weeks | Incidence of adverse events and laboratory abnormalities in each group. |
| Rescue Medication Use | 12 weeks | To calculate the frequency of antacid or analgesic use during the study period. |
Countries
India
Contacts
CONTACTDr.Aniruddha Pratap singh, MD, DM
STUDY_DIRECTORDr.Mohan Kumar Ramchandani, MD, DM
AIG Hospitals
Outcome results
None listed