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

Gastric pH Control Clinical Trial

Official title:

Phase IIIb, Randomized, Triple-blinded and Crossover Study to Evaluate the Effect of Magnesium Pantoprazole 20mg Bid Versus Magnesium Pantoprazole 40mg qd on Intragastric Acid Inhibition Assessed by pHmetry, in Healthy Volunteers

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01499693
• Other study ID #: MX026
• Secondary ID: U1111-1132-3320
• Status: Withdrawn
• Phase: Phase 3
• First received: September 12, 2011
• Last updated: September 14, 2012

Study information

• Verified date: September 2012
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Federal Commission for Sanitary Risks Protection
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric pH Control

Intervention

Drug:
• Magnesium Pantoprazole 20 mg
oral dose, twice a day
• Magnesium Pantoprazole 40 mg
oral dose, once a day (morning)
• Placebo
oral dose, once a day (night) Placebo will be administered at night in the group with 40mg magnesium pantoprazole to keep the blinding (so treatment administration is comparable w/the 20mg group).

Locations

Country	Name	City	State
Mexico	Hospital Español de Mexico	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Percentage of time with intragastric pH above 4.0, measured by continuous 24 hour intragastric pH-Metry.	Electrode will be placed in the gastric lumen, 10 cm below the lower esophageal sphincter. The percentage of time with pH >4.0 between both treatments will be compared.	Three 24-hour measurements will be performed: on day 0 (baseline) and on day 6 of each treatment period.	No
Secondary	Vital signs, physical exploration and common laboratory tests (if required).	Safety will be established by monitoring these clinical criteria	Day 0 (baseline) and day 6 of each treatment period.	Yes