Gastric pH ControlPhase 3NCT01499693
Magnesium Pantoprazole 20mg b.i.d. vs Magnesium Pantoprazole 40mg q.d. on Intragastric Acid Inhibition
A Phase 3 study testing Magnesium Pantoprazole 20 mg and Magnesium Pantoprazole 40 mg in people with Gastric pH Control, run by Takeda at 1 site in Mexico.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastric pH Control
- What is being tested?
- Magnesium Pantoprazole 20 mg and Magnesium Pantoprazole 40 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteMexico
- Study dates
- Start not givento not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed 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.
- Conditions
- Gastric pH Control
- Being tested
- Magnesium Pantoprazole 20 mg, Magnesium Pantoprazole 40 mg, Placebo
- Keywords
- Proton Pump Inhibitors, gastric pH
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium Pantoprazole 20 mgDrug
Also called Tecta 20
oral dose, twice a day
Magnesium Pantoprazole 40 mgDrug
Also called Tecta 40
oral dose, once a day (morning)
PlaceboDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| Magnesium Pantoprazole 20mg | Experimental | Not described Receives: Drug: Magnesium Pantoprazole 20 mg |
| Magnesium Pantoprazole 40mg | Active comparator | Not described Receives: Drug: Magnesium Pantoprazole 40 mg; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Three 24-hour measurements will be performed: on day 0 (baseline) and on day 6 of each treatment period.
Secondary outcomes (1)
Vital signs, physical exploration and common laboratory tests (if required).
Safety will be established by monitoring these clinical criteria
Measured: Day 0 (baseline) and day 6 of each treatment period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric pH ControlStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Edgardo Suarez, MD, MSc, Principal investigator, Clinic at Hospital Español de MexicoJose A Vargas, MD, MSc, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01499693
- Sponsor's protocol ID
- MX026
- Other IDs
- U1111-1132-3320
- Status last verified
- Sep 2012
- First submitted
- 12 Sep 2011
- Last updated
- 17 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01499693
- Acronym / sponsor ID
- MX026
- Conditions
- Gastric pH Control
- Keywords
- Proton Pump Inhibitors, gastric pH
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- First posted
- 26 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnesium Pantoprazole 20mg | Experimental | Drug: Magnesium Pantoprazole 20 mg |
| Magnesium Pantoprazole 40mg | Active comparator | Drug: Magnesium Pantoprazole 40 mg, Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium Pantoprazole 20 mgAlso: Tecta 20oral dose, twice a day | Drug | Magnesium Pantoprazole 20mg |
| Magnesium Pantoprazole 40 mgAlso: Tecta 40oral dose, once a day (morning) | Drug | Magnesium Pantoprazole 40mg |
| Placebooral 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). | Drug | Magnesium Pantoprazole 40mg |
Primary outcome
Change in Percentage of time with intragastric pH above 4.0, measured by continuous 24 hour intragastric pH-Metry.
Time frame: Three 24-hour measurements will be performed: on day 0 (baseline) and on day 6 of each treatment period.
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.
1 secondary outcome
Vital signs, physical exploration and common laboratory tests (if required).
Time frame: Day 0 (baseline) and day 6 of each treatment period.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edgardo Suarez, MD, MSc principal investigator
Clinic at Hospital Español de Mexico
Jose A Vargas, MD, MSc study director
Takeda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Magnesium Pantoprazole 20 mg and Magnesium Pantoprazole 40 mg in people with Gastric pH Control, run by Takeda at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Percentage of time with intragastric pH above 4.0, measured by continuous 24 hour intragastric pH-Metry. (time frame: Three 24-hour measurements will be performed: on day 0 (baseline) and on day 6 of each treatment period.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2012.