A Prospective Study of Pantoprazole 80 mg Dual Release Gastro Resistant Tablets for treatment in Gastro Esophageal Reflux Disease.

Phase 4

Conditions: Health Condition 1: K21- Gastro-esophageal reflux disease

Registration Number: CTRI/2022/08/045065

Lead Sponsor: Sun Pharma Laboratories Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Male or female GERD patient with age between 18 to 65 years (both inclusive).

2. Patient with partial or no response to standard doses of PPI confirmed by:

Patient who have experienced moderate to severe heartburn for at least 1 of 7 days despite on PPI standard dose for duration ranging from 4 to 8 weeks prior to enrolment.

- Moderate: Discomfort sufficient to cause interference with normal activities.

- Severe: Incapacitating, with inability to perform normal activities.

Patient with DeMeester score > 14.7 as confirmed by endoscopy and combined 24-hour pH-Metry/multichannel intraluminal impedance (pH/MII).

3. Patient on standard dose of PPI: Equivalent doses of PPI (Pantoprazole 40 mg, esomeprazole 40 mg, rabeprazole 20 mg, omeprazole 20 mg, lansoprazole 30 mg) once daily for at least 4 to 8 weeks prior to enrolment.

4. Patient is willing to give informed consent and follow the study procedures.

5. Female patient of childbearing potential must be willing to use acceptable method of contraception (female of childbearing potential is defined as one who has not been postmenopausal for at least one year, or has not been surgically sterilized, or has not had a hysterectomy at least three months prior to the start of this study).

Exclusion Criteria

1. Pregnancy and/or Lactation.

2. Patient chronically using systemic steroids ( > 5 doses on demand or for 3 consecutive days) or non-steroidal anti-inflammatory drugs including COX-2 inhibitors including aspirin, and need for continuous anticoagulant therapy.

3. Patient taking any treatment for GERD except conventional PPIs and antacids for duration ranging from 4 to 8 weeks prior to screening or going to take any treatment except study medications and rescue medicines during the study.

4. Patient taking higher than standard dose of PPI in last 8 weeks prior to screening.

5. Current or past history of :

- Increased gastrointestinal motility e.g. in patient with gastrointestinal hemorrhage.

- Mechanical obstruction or perforation.

- Atrophic gastritis or gastric malignancy or other GI malignancy.

- Acute peptic ulcer and/or ulcer complications or history of active gastric or duodenal ulcers within 4 weeks prior to screening.

- Patient with Zollinger-Ellision syndrome or other hyper secretory condition.

- GERD complications like endoscopic BarrettÃ¢â?¬•s esophagus and/or definite dysplastic changes in the esophagus.

- Pyloric stenosis, esophageal stricture, Schatzkis ring, esophageal or gastroesophageal surgery and planned surgery during the study duration.

- Bleeding disorder or history of hematemesis within last 8 weeks.

- Patient with uncontrolled hypertension, uncontrolled diabetes, (HbA1c Ã¢â?°Â¥7%) renal dysfunction (serum creatinine > 2 x upper limit of normal), liver dysfunction [AST (Aspartate amino transferase) or ALT (Alanine amino transferase) > 2 x upper limit of normal], hyper and hypothyroidism [thyroid profile should be within normal range: Total triiodothyronine (T3)- 60-200 mg/dl, total thyroxine (T4)- 4.5-12 Ã?Â¼g/dl, Thyroid stimulating hormone (TSH)- 0.3- 5.5 Ã?Â¼IU/ml)].

- Surgical or medical condition that, in the judgment of the Investigator or Sponsor, could interfere with absorption, distribution, metabolism, or excretion of the study drugs.

- Patient with history of alcohol and / or any form of tobacco/ drug abuse.

- Participation in another clinical trial in the past 3 months.

- Patient having hypersensitivity or any other contraindication to the investigational product or its component.