Digestive System
Conditions
Interventions
Sponsors
SUN PHARMA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Subjects of either gender aged 18 to 65 years • History of gastroesophageal reflux disease (GERD) symptoms (Heartburn ± Regurgitation) for at least 1 month immediately before screening • Heartburn for at least 3 days a week for at least 2 weeks preceding the screening • Willing to provide written informed consent • Women of reproductive age group willing to use an acceptable method of contraception during the conduct of the study
Exclusion criteria
Exclusion criteria: • Active gastric or duodenal ulcer; • Known case of Zollinger Ellison syndrome or Gastrointestinal malignancy • History of oesophageal or gastric surgery or primary oesophageal motility disorder • Active treatment or history of treatment in last 1 month with proton pump inhibitors, H2 blockers or prokinetic drugs • Pregnancy or breast-feeding • Impaired hepatic or renal function; uncontrolled diabetes mellitus or hypertension • Anticoagulation therapy or clotting disorders • Alcoholism or drug abuse • Severe concomitant cardiovascular, hepatic, renal, pulmonary, malignant or haematological disease • Subjects deemed inappropriate by investigator • Patient with “alarm features” in symptomatology, including odynophagia, severe dysphagia, bleeding, weight loss, anemia, and blood in stool, pointing to a possible malignant disease of the GI tract. • Surgical or medical condition that, in the judgement of the Investigator or Sponsor, could interfere with absorption, distribution, metabolism, or excretion of the study drugs. • Patient with history of human immunodeficiency virus (HIV) and/or hepatitis B virus (HBV) and/or hepatitis C virus (HCV). • Participation in another clinical trial in the past 3 months or planning to participate in another clinical trial during the study • Patients having hypersensitivity or any other contraindication to any of the Investigational products or its component.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| •Proportion of patients with sustained resolution of heartburn [7 consecutive heartburn-free days (24 hour period) from baseline] at the end of Week 1 | — |
Secondary
| Measure | Time frame |
|---|---|
| • Time to onset of first heart burn free day (intensity = 0) [Time frame: Wk 1] • Time to onset of relief of heartburn (intensity =1) [Time frame: Wk 1] • Proportion of patients who are heart burn free (Intensity =0 at day time and night time) at Day 2 and at EOT [Time frame: Day 2, Wk 1, 2 & 4] • Proportion of patients with satisfactory relief from heartburn (intensity =1) [Time frame: Wk 1, 4] • Proportion of heartburn free days (daytime and nighttime intensity =0) [Time frame: Wk 1 & 4] • Proportion of Days without day time heartburn [Time frame: Wk 1 & 4] • Proportion of Days without night time heartburn [Time frame: Wk 1 & 4] • Reduction in heartburn and regurgitation score [Time frame: Wk 1 & 4] • Change in the CGI-I from baseline [Time frame: Wk 1& 4] • Proportion of responders (Very much improved, or much improved) as per CGI-Improvement Scale [Time frame: Wk 1& 4] • Proportion of patients using rescue medication [Time frame: Wk 1& 4] • Percentage of days without rescue medication [Time frame: Wk 1& 4] • Proportion of participants with adverse events (AEs) and serious adverse events (SAEs) [Time frame: 4 weeks] | — |
Countries
Morocco
Contacts
Public Contactsameer Rao
General manager medical affairs and clinical trials
Outcome results
None listed