Gastroesophageal Reflux DiseasePhase 1NCT03069963
PH Metry Study to Compare the Antacid Activity of Z0063 Versus Gaviscon Double Action Tablets, in Healthy Adult Subjects
A Phase 1 study testing Z0063 and Gaviscon in people with Gastroesophageal Reflux Disease, run by Sanofi at 1 site in France.
Trial summary
Primary Objective: Pharmacodynamics: assessment by pH metry of the change in gastric pH (antacid activity) of Z0063, in comparison to the effect of Gaviscon Double Action Tablets, in healthy adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastroesophageal Reflux Disease
- What is being tested?
- Z0063 and Gaviscon
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 24 Feb 2017to 23 Apr 2017
- Phase
- Phase 1
- 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female subjects, between 18 and 55 years of age, inclusive.
- Body weight between 50.0 and 100.0 kg, inclusive, if male, and between 40.0 and 90.0 kg, inclusive, if female, body mass index between 18.0 and 28.0 kg/m2, inclusive.
- Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).
- Normal vital signs, electrocardiogram (ECG) and laboratory parameters.
- Subject has to accept a gastric probe.
Who cannot join
- Any history or presence of clinically relevant abnormalities at screening which could interfere with the objectives of the study or the safety of the subject's participation.
- Blood donation, any volume, within 2 months before inclusion.
- History or presence of drug or alcohol abuse.
- Smoking more than 5 cigarettes or equivalent per day, unable to stop smoking during the study.
- If female, pregnancy (defined as positive beta-human chorionic gonadotropin [β-HCG] blood test), breast-feeding.
- Any medication (including St John's Wort) within 14 days before inclusion, with the exception of hormonal contraception or menopausal hormone replacement therapy; any vaccination within the last 28 days and any biologics (antibody or its derivatives) given within 4 months before inclusion.
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- Any subject in the exclusion period of a previous study according to applicable regulations.
- Any subject who cannot be contacted in case of emergency.
- Positive result on any of the following tests: hepatitis B surface (HBs Ag) antigen, anti-hepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV1 and anti-HIV2 Ab).
- Positive result on urine drug screen.
- Positive alcohol breath test.
- Known hypersensitive to alginates, products or formulation excipients, and/or to any component of the standardized meal.
- Any subject with difficulty in chewing and swallowing.
- Any subject with strong gag reflex.
- Any intake of aluminium and magnesium containing antacids or other alginate-containing medicinal products within 14 days before inclusion.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open Label, 2-Treatment Crossover Study to Compare by pH Metry, the Antacid Activity of the To-be-registered Product (250 mg Sodium Alginate/187.5 mg Calcium Carbonate/106.5 mg Sodium Hydrogen Carbonate, Chewable Tablets) Versus the Registered Gaviscon Double Action Tablets, in Healthy Adult Subject
Primary Objective:
Pharmacodynamics: assessment by pH metry of the change in gastric pH (antacid activity) of Z0063, in comparison to the effect of Gaviscon Double Action Tablets, in healthy adult subjects.
Secondary Objective:
Safety: assessment of the clinical safety of Z0063, and Gaviscon Double Action Tablets, in healthy adult subjects.
Read the detailed description
The maximal total study duration per subject is 5 weeks and 1 day.
- Conditions
- Gastroesophageal Reflux Disease
- Being tested
- Z0063, Gaviscon
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Z0063Drug
Pharmaceutical form: chewable tablets
Route of administration: oral
GavisconDrug
Pharmaceutical form: chewable tablets
Route of administration: oral
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 (Z0063 to Gaviscon) | Experimental | The subjects will be given Z0063 single dose and then will crossover to Gaviscon single dose Receives: Drug: Z0063; Drug: Gaviscon |
| Sequence 2 (Gaviscon to Z0063) | Experimental | The subjects will be given Gaviscon single dose and then will crossover to Z0063 single dose Receives: Drug: Z0063; Drug: Gaviscon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of time at which the intragastric pH is at least equal to or greater than 4 during the 4-hour observation period post-dose
Measured: 4 hours after the investigational medicinal product (IMP) administration
Secondary outcomes (2)
Percentage of time at which the intragastric pH is at least equal to or greater than 3 during the 4-hour observation period post-dose
Measured: 4 hours after the IMP administration
4-hour median pH
Measured: 4 hours after the IMP administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
- Study start24 Feb 2017
- Primary completion23 Apr 2017
- Study completion23 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- More trials run by SanofiThe 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03069963
- Sponsor's protocol ID
- PDY14362
- Other IDs
- 2015-000763-13, U1111-1183-5042, 2015
- Status last verified
- Jun 2017
- First submitted
- 28 Feb 2017
- Last updated
- 12 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, 2-Treatment Crossover Study to Compare by pH Metry, the Antacid Activity of the To-be-registered Product (250 mg Sodium Alginate/187.5 mg Calcium Carbonate/106.5 mg Sodium Hydrogen Carbonate, Chewable Tablets) Versus the Registered Gaviscon Double Action Tablets, in Healthy Adult Subject
- ClinicalTrials.gov ID
- NCT03069963
- Acronym / sponsor ID
- PDY14362
- Conditions
- Gastroesophageal Reflux Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 24 Feb 2017 (actual)
- Primary completion
- 23 Apr 2017 (actual)
- Study completion
- 23 Apr 2017 (actual)
- First posted
- 3 Mar 2017 (actual)
- 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.
Primary Objective:
Pharmacodynamics: assessment by pH metry of the change in gastric pH (antacid activity) of Z0063, in comparison to the effect of Gaviscon Double Action Tablets, in healthy adult subjects.
Secondary Objective:
Safety: assessment of the clinical safety of Z0063, and Gaviscon Double Action Tablets, in healthy adult subjects.
Detailed description
The maximal total study duration per subject is 5 weeks and 1 day.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 (Z0063 to Gaviscon) | Experimental | Drug: Z0063, Drug: GavisconThe subjects will be given Z0063 single dose and then will crossover to Gaviscon single dose |
| Sequence 2 (Gaviscon to Z0063) | Experimental | Drug: Z0063, Drug: GavisconThe subjects will be given Gaviscon single dose and then will crossover to Z0063 single dose |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male or female subjects, between 18 and 55 years of age, inclusive.
- Body weight between 50.0 and 100.0 kg, inclusive, if male, and between 40.0 and 90.0 kg, inclusive, if female, body mass index between 18.0 and 28.0 kg/m2, inclusive.
- Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).
- Normal vital signs, electrocardiogram (ECG) and laboratory parameters.
- Subject has to accept a gastric probe.
Key exclusion criteria (16 listed)
- Any history or presence of clinically relevant abnormalities at screening which could interfere with the objectives of the study or the safety of the subject's participation.
- Blood donation, any volume, within 2 months before inclusion.
- History or presence of drug or alcohol abuse.
- Smoking more than 5 cigarettes or equivalent per day, unable to stop smoking during the study.
- If female, pregnancy (defined as positive beta-human chorionic gonadotropin [β-HCG] blood test), breast-feeding.
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 |
|---|---|---|
| Z0063Pharmaceutical form: chewable tablets Route of administration: oral | Drug | Sequence 1 (Z0063 to Gaviscon), Sequence 2 (Gaviscon to Z0063) |
| GavisconPharmaceutical form: chewable tablets Route of administration: oral | Drug | Sequence 1 (Z0063 to Gaviscon), Sequence 2 (Gaviscon to Z0063) |
Primary outcome
Percentage of time at which the intragastric pH is at least equal to or greater than 4 during the 4-hour observation period post-dose
Time frame: 4 hours after the investigational medicinal product (IMP) administration
2 secondary outcomes
Percentage of time at which the intragastric pH is at least equal to or greater than 3 during the 4-hour observation period post-dose
Time frame: 4 hours after the IMP administration
4-hour median pH
Time frame: 4 hours after the IMP administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2022.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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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.
Clinical Sciences & Operations study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Z0063 and Gaviscon in people with Gastroesophageal Reflux Disease, run by Sanofi at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. 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: finished, as of the sponsor's last update on 12 May 2022. 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 France. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of time at which the intragastric pH is at least equal to or greater than 4 during the 4-hour observation period post-dose (time frame: 4 hours after the investigational medicinal product (IMP) administration). 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 12 May 2022.