Acid RefluxPhase 1NCT01710995
A Three-Period Study to Investigate the Relative Bioavailability and Pharmacodynamic Profiles of a Zegerid 20mg Capsule, Zegerid 20mg Powder for Oral Suspension and Losec 20mg Capsule in Healthy Adult Volunteers Under Fasting Conditions
A Phase 1 study testing Zegerid and Losec in people with Acid Reflux and Gastro Oesophageal Reflux Disease, run by Norgine at 1 site in United Kingdom.
Trial summary
The purpose of this study is to assess the effectiveness of Zegerid 20mg capsules and powder and Losec 20mg capsules in healthy volunteers under fasting conditions. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Acid Reflux, Gastro Oesophageal Reflux Disease
- What is being tested?
- Zegerid and Losec
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2010to Feb 2011
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult male or female volunteers aged 18 - 45 years.
- Non-smokers from three months before receiving the first dose and for the duration of the study, confirmed by negative urinary cotinine test at screening and check-in.
- Body mass index (BMI) ≥ 18.0 and ≤ 27.9 kg/m2.
- Able to voluntarily provide written informed consent to participate in the study.
- Must understand the purposes and risks of the study and agree to follow the restrictions and schedule of procedures as defined in the protocol.
- Able and willing to have a nasogastric tube/probe inserted.
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- Females must be post-menopausal (for at least one year and confirmed by serum FSH at screening), surgically sterile, practicing true sexual abstinence or using an acceptable form of effective contraception throughout the study from the following list: contraceptive implants, injectables, oral contraceptives, intrauterine system (IUS), some intrauterine devices (IUDs), vasectomised partner or barrier method (condom or occlusive cap) with spermicidal foam/gel/film/cream/suppository.
- Hormonal and IUD methods of contraception must be established for a period of three months prior to dosing and cannot be changed or altered during the study.
- Females of childbearing potential must have a negative pregnancy test at screening and check-in.
- Must be willing to consent to have data entered into The Over Volunteering Prevention System (TOPS).
- The volunteer's primary care physician must confirm that there is nothing in their medical history that would preclude their enrolment into this clinical study.
Who cannot join
- Positive for HIV, hepatitis B or hepatitis C.
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease as determined by the Investigator.
- History of gastric or duodenal ulcer.
- History of hiatus hernia.
- Significant history of reflux symptoms on clinical judgement.
- Diagnosis of conditions likely to result in a hypersecretory gastric acid state e.g. Zollinger-Ellison Syndrome.
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- Positive serology test result for H. pylori at screening.
- Clinically significant deviated nasal septum or other nasopharyngeal obstruction, or inability to tolerate or site a nasogastric tube at screening.
- Hypersensitivity or any other contraindication to Zegerid® or Losec®.
- History or presence of any clinically significant drug allergy.
- Female subjects who are pregnant or lactating.
- Laboratory values at screening which are deemed to be clinically significant as determined by the Investigator.
- Any clinically relevant history of drug or alcohol abuse.
- Volunteers who, in the opinion of the Investigator, are unsuitable for participation in the study.
- Participation in a clinical drug study during the 90 days preceding the initial dose of study medication.
- Any significant illness during the screening period preceding the initial dose of study medication.
- Donation of blood or blood products within 90 days prior to study drug administration, or at any time during the study, except as required by this protocol.
- Consumption of alcoholic beverages or xanthine-containing products within 24 hours before confinement or during study confinement.
- Consumption of cruciferous vegetables or chargrilled foods within 48 hours before confinement or during study confinement.
- Consumption of grapefruit or grapefruit juice from seven days before confinement and until the end of the study.
- Use of any prescription or over-the-counter medication (including vitamins, herbal and mineral supplements) within 30 days before study drug administration, or any general anaesthetic during the three months before study drug administration, and until the end of the study, with the exception of Investigator-approved hormonal contraceptives, HRT and occasional paracetamol.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Bio-Kinetic Europe Limited, 14 Great Victoria Street, Belfast BT2 7BA
Belfast, BT2 7BA
About this study
Official title: A Randomised, Three-Period, Single Dose, Open-Label, Crossover Study to Investigate the Relative Bioavailability and Pharmacodynamic Profiles of a Zegerid 20mg Capsule, Zegerid 20mg Powder for Oral Suspension and Losec 20mg Capsule in Healthy Adult Volunteers Under Fasting Conditions
The purpose of this study is to assess the effectiveness of Zegerid 20mg capsules and powder and Losec 20mg capsules in healthy volunteers under fasting conditions.
- Conditions
- Acid Reflux, Gastro Oesophageal Reflux Disease
- Being tested
- Zegerid, Losec
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZegeridDrug
LosecDrug
| Study group | Role | What they receive |
|---|---|---|
| Zegerid 20mg capsule | Active comparator | Zegerid 20mg capsule (20mg omeprazole and 1100mg sodium carbonate Receives: Drug: Zegerid |
| Zegerid 20mg powder for oral suspension | Active comparator | Zegerid 20mg powder for oral suspension (20mg omeprazole and 1680mg sodium bicarbonate) Receives: Drug: Zegerid |
| Losec 20mg capsule | Active comparator | Losec 20mg capsule (20mg omeprazole) Receives: Drug: Losec |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioavailability - Area under Curve of pH at 2 hours
To assess the relative bioavailability of two immediate release formulations of omeprazole/sodium carbonate (Zegerid 20mg capsule and Zegerid 20mg powder for oral suspension)
Measured: 2 hours
Pharmacodynamics - Area under Curve of pH at 2 hours
To assess the relative pharmacodynamic profiles of two immediate release formulations of omeprazole/sodium bicarbonate (Zegerid® 20mg capsule and Zegerid® 20mg powder for oral suspension).
Measured: 2 hours
Secondary outcomes (5)
Safety and tolerability of study formulations using measurements of Cmax, tmax and t1/2
To assess the safety and tolerability of these three formulations after single dose oral administration. To include measurements of Cmax, tmax and t1/2
Measured: pre-dose on day 1, and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose
Bioavailability - measurement of pH over time
To assess the relative bioavailability of an immediate release formulation of omeprazole/sodium bicarbonate (Zegerid 20mg capsule) and a delayed-release omeprazole capsule (Losec 20mg) after single dose oral administration in a fasted state. AUC of pH and % of time for pH to raise above 4 (0.5, 1, 1.5, 3, 4, 8, 12, 16 and 24 hours)
Measured: 0.5, 1, 1.5, 3, 4, 8, 12, 16 and 24 hours
Bioavailability - measurement of pH over time
To assess the relative bioavailability of an immediate release formulation of omeprazole/sodium bicarbonate (Zegerid 20mg powder for oral suspension) and a delayed-release omeprazole capsule (Losec 20mg) after single dose oral administration in a fasted state. AUC of pH and % of time for pH to raise above 4 (0.5, 1, 1.5, 3, 4, 8, 12, 16 and 24 hours)
Measured: 0.5, 1, 1.5, 3, 4, 8, 12, 16 and 24 hours
Pharmacodynamic Measurements of Cmax, Tmax and t1/2
To assess the relative pharmacodynamic profiles of an immediate release formulation of omeprazole/sodium bicarbonate (Zegerid 20mg capsule) and a delayed-release omeprazole capsule (Losec 20mg) after single dose oral administration in a fasted state.
Measured: Pre-dose on day 1, and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose
Pharmacodynamic measurements of Cmax, Tmax and t1/2
To assess the relative pharmacodynamic profiles of an immediate release formulation of omeprazole/sodium bicarbonate (Zegerid 20mg powder for oral suspension) and a delayed-release omeprazole capsule (Losec 20mg) after single dose oral administration in a fasted state
Measured: Pre-dose on day 1, and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2012 (estimated)
- Study startOct 2010
- Primary completionNov 2010
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acid RefluxStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norgine
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jerome Hanna, MB BCH MRCS, Principal investigator, Bio-Kinetic Europe, Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01710995
- Sponsor's protocol ID
- ZEG-02/2010 (BE)
- Status last verified
- Oct 2012
- First submitted
- 3 Aug 2012
- Last updated
- 19 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Three-Period, Single Dose, Open-Label, Crossover Study to Investigate the Relative Bioavailability and Pharmacodynamic Profiles of a Zegerid 20mg Capsule, Zegerid 20mg Powder for Oral Suspension and Losec 20mg Capsule in Healthy Adult Volunteers Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT01710995
- Acronym / sponsor ID
- ZEG-02/2010 (BE)
- Conditions
- Acid Reflux, Gastro Oesophageal Reflux Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- NorgineIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 19 Oct 2012 (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 assess the effectiveness of Zegerid 20mg capsules and powder and Losec 20mg capsules in healthy volunteers under fasting conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Zegerid 20mg capsule | Active comparator | Drug: ZegeridZegerid 20mg capsule (20mg omeprazole and 1100mg sodium carbonate |
| Zegerid 20mg powder for oral suspension | Active comparator | Drug: ZegeridZegerid 20mg powder for oral suspension (20mg omeprazole and 1680mg sodium bicarbonate) |
| Losec 20mg capsule | Active comparator | Drug: LosecLosec 20mg capsule (20mg omeprazole) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Healthy adult male or female volunteers aged 18 - 45 years.
- Non-smokers from three months before receiving the first dose and for the duration of the study, confirmed by negative urinary cotinine test at screening and check-in.
- Body mass index (BMI) ≥ 18.0 and ≤ 27.9 kg/m2.
- Able to voluntarily provide written informed consent to participate in the study.
- Must understand the purposes and risks of the study and agree to follow the restrictions and schedule of procedures as defined in the protocol.
Key exclusion criteria (21 listed)
- Positive for HIV, hepatitis B or hepatitis C.
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease as determined by the Investigator.
- History of gastric or duodenal ulcer.
- History of hiatus hernia.
- Significant history of reflux symptoms on clinical judgement.
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 |
|---|---|---|
| Zegerid | Drug | Zegerid 20mg capsule, Zegerid 20mg powder for oral suspension |
| Losec | Drug | Losec 20mg capsule |
Primary outcome
Bioavailability - Area under Curve of pH at 2 hours
Time frame: 2 hours
To assess the relative bioavailability of two immediate release formulations of omeprazole/sodium carbonate (Zegerid 20mg capsule and Zegerid 20mg powder for oral suspension)
Pharmacodynamics - Area under Curve of pH at 2 hours
Time frame: 2 hours
To assess the relative pharmacodynamic profiles of two immediate release formulations of omeprazole/sodium bicarbonate (Zegerid® 20mg capsule and Zegerid® 20mg powder for oral suspension).
5 secondary outcomes
Safety and tolerability of study formulations using measurements of Cmax, tmax and t1/2
Time frame: pre-dose on day 1, and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose
Bioavailability - measurement of pH over time
Time frame: 0.5, 1, 1.5, 3, 4, 8, 12, 16 and 24 hours
Bioavailability - measurement of pH over time
Time frame: 0.5, 1, 1.5, 3, 4, 8, 12, 16 and 24 hours
Pharmacodynamic Measurements of Cmax, Tmax and t1/2
Time frame: Pre-dose on day 1, and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose
Pharmacodynamic measurements of Cmax, Tmax and t1/2
Time frame: Pre-dose on day 1, and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose
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 19 Oct 2012.
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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.
Jerome Hanna, MB BCH MRCS principal investigator
Bio-Kinetic Europe, Ltd.
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 Zegerid and Losec in people with Acid Reflux and Gastro Oesophageal Reflux Disease, run by Norgine at 1 site in United Kingdom.
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 11 inclusion and 21 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 19 Oct 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 United Kingdom. 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?
Bioavailability - Area under Curve of pH at 2 hours (time frame: 2 hours). The study lists 2 primary outcomes in all. 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 19 Oct 2012.