A study of the effect of Digene Total on 24 hour gastric pH in patients suffering from acid peptic disorder after single and repeated dosing

Phase 4

Completed

Conditions: Health Condition 1: null- Acid Peptic Disorders

Registration Number: CTRI/2010/091/001362

Lead Sponsor: Abbott India Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 49

Inclusion Criteria

1. Adult subjects (18-65 years) suffering from APD, diagnosed endoscopically (reflux esophagitis, gastritis and peptic ulcer)

2. Must voluntarily sign and date an informed consent form, approved by an Independent Ethics Committee (IEC)/ Institutional Review Board (IRB), prior to any study specific procedures.

3. If female, subject must be either postmenopausal for at least 1 year, surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or practicing at least one of the following methods of birth control:

3.a. Total abstinence from sexual intercourse (minimum one completed menstrual cycle)

3.b. A vasectomized partner

3.c. Hormonal contraceptives (oral, parenteral or transdermal) for at least 3 months prior to study drug administration.

3.d. Intrauterine device (IUD)

3.e. Double barrier method (condoms, contraceptive sponge, diaphragm or vaginal ring with spermicidal jellies or creams)

Exclusion Criteria

1. Subjects with concurrent gastrointestinal diseases, gastric surgery, perforation or bleeding
2. Subjects who have a history of use of any antisecretory drug within past 7 days prior study Day 0
3. Subjects with cardiac, neurological, renal or hepatic dysfunction
4. Past history of significant sensitivity or contraindication to study drug
5. Pregnant or breast-feeding female
6. Any condition that, in the opinion of the Investigator, does not justify the subject?s inclusion for the study

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time taken to achieve a gastric pH of 4 after a single dose of Digene TotalTimepoint: Assessment done on day 1 for group A subjects

Secondary Outcome Measures

Name	Time	Method
1. Percentage of time gastric pH was 4 after repeated dosing of Digene Total <br/ ><br>2. 24 hour median gastric pH after repeated dosing of Digene TotalTimepoint: 1. Assessment done on day 7 for all subjects <br/ ><br>2. Assessment done on day 7 for all subjects <br/ ><br>