Magnesium Pantoprazole 20mg b.i.d. vs Magnesium Pantoprazole 40mg q.d. on Intragastric Acid Inhibition

Takeda

Status and phase

Withdrawn

Phase 3

Conditions

Gastric pH Control

Treatments

Drug: Placebo

Drug: Magnesium Pantoprazole 40 mg

Drug: Magnesium Pantoprazole 20 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT01499693

U1111-1132-3320 (Registry Identifier)

MX026

Details and patient eligibility

About

The purpose of this study is to determine if magnesium pantoprazole 20 mg twice a day (b.i.d.), maintains gastric pH above 4 during a longer percentage of time than magnesium pantoprazole 40 mg once a day (qd). This is a comparison between split dose concept and standard dose of proton pump inhibitors.

Full description

Eligible healthy volunteers will be randomly assigned for 2 different treatment sequences: A) magnesium pantoprazole 20 mg b.i.d. followed by magnesium pantoprazole 40 mg q.d. or B) magnesium pantoprazole 40 mg q.d. followed by magnesium pantoprazole 20 mg b.i.d.

Treatment sequences will be administrated as follows: 6 days with the first medication, followed by a washout period of 8 days (no medication) and a further period of 6 days with the second medication.

Treatment efficacy will be established by the percentage of time with intragastric pH >4, measured by 24-hour pH-Metry on day 6 of each medication (on-treatment measurement). Basal pH will be measured as reference.

The blinding distribution of treatments will be maintained for the patients, the doctor and the statistician who will analyze the data.

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Main inclusion criteria:

Carlsson-Dent Questionnaire with score ≤ 4 (negative for GERD).
Endoscopy: negative for GERD
BMI between 18.5 and 30

Main exclusion criteria:

Volunteers with any the following symptoms: dysphagia, digestive track bleeding, anorexia, anemia, involuntary weight loss.
Women under breastfeeding period, pregnant or under pregnancy suspicion.
Subjects with abnormal manometry (any motor esophageal disorder).
Peptic ulcer history and/or ulcer complication.
Volunteers under PPI treatment, H. pylori eradication treatment, H2 receptor antagonists, prokinetics or similar medication (current, during the last 30 days or during the trial).
History of systemic glucocorticoids or non-steroidal anti-inflammatory drugs (NSAID) use, during the last 30 days.
Abnormal laboratory parameters or vital signs, considered clinically relevant by the researcher.