CTRI/2023/04/051516Not yet recruitingPhase 3
A Phase III, Randomized, Multi-centric, Double-blind, Double-dummy, Parallel-group, Prospective Study to Evaluate Efficacy and Safety of FDC of Acotiamide (As ER) 300 mg plus Pantoprazole 40 mg Capsule Compared to Monotherapy of Pantoprazole 40 mg tablet in patients with Refractory Gastroesophageal Reflux Disease (GERD) and Functional Dyspepsia
AKUMS DRUGS & PHARMACEUTICALS LIMITED8 sites in 1 country210 target enrollmentStarted: May 5, 2023Last updated:
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Enrollment
- 210
- Locations
- 8
- Primary Endpoint
- Proportion of patients in the two treatment groups with ≥ 50% reduction (responders) from baseline to end of treatment (Week 12) in the total score for three upper gastrointestinal symptoms (heartburn, epigastralgia, and epigastric fullness) in the Izumo scale
Study Overview
Brief Summary
After informed consent process, completion of all screening assessments and once all the inclusion/exclusion criteria are met, the eligible subjects shall be enrolled into the study. Demographics, Medical and surgical history shall be recorded during screening visit. Physical examination shall be done during screening and each successive visit. Vital signs shall be measured during screening and each successive visit. Details of concomitant medications and adverse events if any shall be recorded during each visit.
At randomization/baseline visit, subjects shall be randomly (Double blind) assigned in 1:1 fashion to one of the two treatment groups. Subjects shall be instructed to administer, test or comparator product, once daily orally, for the duration of 12 weeks. Study medication shall be swallowed whole and should not be opened, crushed, or chewed.
An adverse event and concomitant medication forms will be provided to subjects to record details of adverse events and concomitant medications if any.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Male and female subjects between 18 to 65 years of age (both inclusive).
- •Patients with refractory GERD (erosive or non-erosive reflux disease confirmed by upper gastrointestinal endoscopy) i.e., those who have failed on conventional treatment.
- •(Conventional treatment: Pantoprazole 40 mg tablet once daily for at least 8 weeks).
- •Subjects diagnostically confirmed of having Functional Dyspepsia (FD) with no evidence of gastric and duodenal organic abnormality by upper gastrointestinal endoscopy.
- •Patients who have experienced heartburn symptom on at least 2 of 7 days and regurgitation symptom on at least 1 of 7 days for at least 8 weeks prior to enrolment.
- •Female Subjects, of childbearing potential practicing an acceptable method of birth control such as sexual abstinence, intrauterine device IUD, a double-barrier method, condom plus spermicide, diaphragm plus spermicide, or vaginal spermicidal suppository; for the duration of the study as judged by the investigator(s)/study physician and agree to follow the same should be used during treatment.
- •OR Postmenopausal for at least 1 year.
- •OR Surgically sterile (bilateral tubal ligation/bilateral oophorectomy/ hysterectomy has been performed on the Subject).
- •Subjects who are able to understand and give voluntary, written informed consent to participate in this clinical investigation.
- •Subjects shall be willing, able to comply with the protocol requirements.
Exclusion Criteria
- •Subjects using Proton Pump Inhibitor (PPI) other than pantoprazole.
- •Subjects planning to take an inhibitor of gastric acid secretion other than Pantoprazole, a prokinetic drug other than Acotiamide, or any herbal medicine for gastrointestinal disorders.
- •Subjects who had undergone total gastrectomy.
- •Subjects with symptoms of Irritable Bowel Disease (IBD).
- •Patients chronically (> 5 doses on demand or for 3 consecutive days) using systemic corticosteroids or non-steroidal anti-inflammatory drugs including COX-2 inhibitors other than aspirin (less than or equal to 325 mg is allowed) within last 28 days prior to screening. Need for continuous anticoagulant therapy 6.Current or past history of:.
- •Patients with gastrointestinal hemorrhage, mechanical obstruction or perforation.
- •Atrophic gastritis or documented gastric malignancy or other GI malignancy.
- •History of active gastric or duodenal ulcers within 4 weeks prior to screening.
- •GERD complications like Barretts oesophagus and/or definite dysplastic changes in the oesophagus.
- •Pyloric stenosis, oesophageal stricture, Schatzkis ring, oesophageal or Gastroesophageal surgery and planned surgery during the study duration.
- •History of hematemesis within last 2 months.
- •Clinically significant conditions as per investigator discretion.
- •Subjects with history of liver, gallbladder, and pancreatic disorders.
- •Subjects confirmed positive for Helicobacter pylori by the rapid urease test.
- •Subjects with abnormal eGFR (< 60 mL/min/1.73 m2) will be excluded from the study.
- •Subjects with abnormal Liver Function Test (AST & ALT) with values more than 2.5 times the upper limit of normal.
- •Subjects with known case of Oncological Conditions.
- •Subjects with known history of infection with HIV, Hepatitis B virus or Hepatitis C virus.
- •Subject with any clinically significant laboratory abnormalities at screening as per investigator discretion.
- •Subjects with any other medical condition that might adversely impact the safety of the study participants or confound the study results.
- •Suspected hypersensitivity to Pantoprazole or Acotiamide or any of the ingredients of the formulation.
- •Female subjects who are pregnant or lactating or planning to become pregnant during the study period.
- •Female subjects who are not ready to use acceptable contraceptive methods during the course of study.
- •Female subjects with positive urine pregnancy test at screening.
- •Subjects with drug abuse or having any condition that would compromise compliance with this protocol.
- •Subjects who have been treated with an investigational drug or investigational device within a period of 4 weeks prior to study entry.
- •Currently taking prohibited concomitant medication(s) listed and inability/unwillingness to discontinue them for the entire study period.
- •Suspected inability or unwillingness to comply with the study procedures.
Outcomes
Primary Outcomes
Proportion of patients in the two treatment groups with ≥ 50% reduction (responders) from baseline to end of treatment (Week 12) in the total score for three upper gastrointestinal symptoms (heartburn, epigastralgia, and epigastric fullness) in the Izumo scale
Time Frame: Visit 1: Screening Visit ; Visit 2:Randomization/Baseline Visit; | Visit 3 & 4: Interim Visits; Visit 5: End of Treatment/Early Termination Visit
Secondary Outcomes
- Comparison of the difference (from baseline to end of treatment (Week 12)) in each score between two treatment groups for each symptom (total, three upper gastrointestinal symptoms, heartburn, epigastralgia, epigastric fullness, constipation, and diarrhoea) in the Izumo scale(Visit 1: Screening Visit ; Visit 2:Randomization/Baseline Visit;)
- Evaluation of the FSSG scale scores for each symptom (total score, FD score, and GERD score) and comparison of the differences (from baseline to end of treatment (Week 12)) in each score between two treatment groups.(Visit 1: Screening Visit ; Visit 2:Randomization/Baseline Visit;)
- Proportion of patients with endoscopically confirmed healing of reflux oesophagitis after 12 weeks compared to baseline(Visit 1: Screening Visit ; Visit 2:Randomization/Baseline Visit;)
Investigators
Study Sites (8)
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