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
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Status | Withdrawn |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 |
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 |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Mexico | Hospital Español de Mexico | Mexico City |
Lead Sponsor | Collaborator |
---|---|
Takeda |
Mexico,
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 |