Gastroesophageal RefluxPhase 1NCT00818870
Effect of Vecam 40/300 and Vecam 20/300 Compared to Omeprazole 20 mg on Gastric pH
A Phase 1 study testing Omeprazole and Vecam in people with Gastroesophageal Reflux, run by Vecta Ltd. at 1 site in United States.
Trial summary
The study is designed to assess and compare the effect of Vecam 40/300, Vecam 20/300 and Omeprazole 20 mg (a standard FDA approved GERD treatment) on the control of gastric pH. 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
- What is being tested?
- Omeprazole and Vecam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Jun 2009
- 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
- Healthy, H. pylori negative status (by Urea Breath Test)
- Male or female subjects
- Age 18-55 years
- Able to tolerate the placement of a nasogastric pH probe at screening
- Baseline Gastric pH≤2
- Use of acceptable form of birth control in females with child-bearing potential
Show all 10Show fewer
- Had not used any form of tobacco (e.g. smoking or chewing) for the last year
- Can swallow a size "00" capsule without difficulty
- Willing to comply with study protocol
- Signed Informed Consent form
Who cannot join
- BMI > 40
- Slow or poor Omeprazole metabolizers (heterozygous or homozygous, respectively) based on CYP2C19 genotyping test.
- Any significant history of / or concurrent gastrointestinal diseases or conditions such as:
- GERD
- Acute gastrointestinal bleeding
- Zollinger Ellison Syndrome or Gastric hypersecretory condition
Show all 32Show fewer
- Known Barrett's esophagus
- Esophageal stricture
- Peptic ulcer disease (gastric or duodenal) or family history of peptic ulcer disease
- Gastric outlet obstruction
- Gastroparesis
- Significant medical history or concurrent illness as determined by the principal investigator
- Any medical disorder that alters the normal gastric acid secretion profile as determined by the principal investigator
- History of diabetes mellitus
- Significant laboratory abnormalities as determined by the principal investigator
- Known metabolic alkalosis, hypocalcemia, sodium restricted diet, hypokalemia, respiratory alkalosis
- Pregnant or lactating women
- Had been treated with any investigational drug or therapy or participated in a clinical trial within 30 days prior to entering the trial
- Use of any medication other than contraception or hormone replacement therapy; OTC drugs other than vitamins or occasional acetaminophen within 30 days prior to entering the trial or during the trial
- Use of NSAID medications within 30 days prior to entering the trial (e.g. Ibuprofen, Aspirin, Naproxen etc)
- Positive urine test for alcohol or other drugs
- Concurrent use of gastric anti-secretory drugs such as defined below:
- Use of a PPI 30 days prior to each stage or during the trial
- Use of H2RA 14 days prior to each stage or during the trial
- Concurrent use of antacids (including over-the-counter) 24 hours prior to each stage or during the trial
- Use of any medication that modifies gastric acid secretion 30 days prior to or during the trial.
- Had ingested grapefruit within 14 days of dose administration in any trial period
- Significant drug allergy or known hypersensitivity to any of the ingredients in the trial drugs Omeprazole, Succinic Acid or to Lidocaine
- Consumption of coffee within 48 hours of dose administration in any trial period.
- Had donated blood within 30 days of entering the trial
- Known positive serology for HBV, HCV or HIV
- Any reason which makes the subject a poor candidate based on the physician's discretion
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Applications Laboratories Inc.
San Diego, California, 92103
About this study
Official title: A Randomized, Open-Label, Cross-Over, Dose-Ranging Study to Assess the Effect of Vecam 40/300 and Vecam 20/300 Administered at Bedtime Compared to Omeprazole 20 mg Administered Before Breakfast on Gastric pH
The study is designed to assess and compare the effect of Vecam 40/300, Vecam 20/300 and Omeprazole 20 mg (a standard FDA approved GERD treatment) on the control of gastric pH.
Read the detailed description
Eligible H. pylori negative, normal gastric acid secreting, healthy volunteers will be treated by the study medications in a randomized, open-label, cross-over study.Up to 60 volunteers may be enrolled to ensure that at least 30 subjects will complete all the study treatments. Omeprazole 20 mg will be administered before breakfast. Vecam 40/300 and Vecam 20/300 will be administered at bedtime w/o food. 24-hour gastric pH will be measured after the fifth dose (day 5).Following screening procedures, subjects will be randomly assigned to receive the different treatments.
All pH measurements will be done in the study center under supervised conditions. All drug administrations will be supervised.
This study is part of the Vecam clinical development plan.
- Conditions
- Gastroesophageal Reflux
- Being tested
- Omeprazole, Vecam
- Keywords
- Gastroesophageal Reflux, GERD, Nocturnal GERD, Heartburn, Nighttime Heartburn, Nocturnal Heartburn
- Medical subject headings
- Gastroesophageal Reflux, Heartburn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmeprazoleDrug
20 mg capsule, orally, once daily (before breakfast) for 5 days.
VecamDrug
1 capsule, orally, once daily at bedtime for 5 days.
VecamDrug
1 capsule, orally, once daily at bedtime for 5 days.
| Study group | Role | What they receive |
|---|---|---|
| Omeprazole 20 mg | Active comparator | Not described Receives: Drug: Omeprazole |
| Vecam 20/300 | Experimental | Not described Receives: Drug: Vecam |
| Vecam 40/300 | Experimental | Not described Receives: Drug: Vecam |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess whether Vecam 40/300 administered at bedtime w/o food is pharmacodynamically superior to Omeprazole 20 mg administered before breakfast, calculated as percent time gastric pH ≥4 for the 24-hour interval after the fifth dose.
Measured: 5 days
Secondary outcomes (7)
To assess whether Vecam 40/300 administered at bedtime w/o food is pharmacodynamically superior to Vecam 20/300 administered at bedtime w/o food calculated as percent time gastric pH ≥4 for the 24-hour interval after the fifth dose.
Measured: 5 days
To assess whether Vecam 20/300 administered at bedtime w/o food is pharmacodynamically superior to Omeprazole 20 mg administered before breakfast, calculated as percent time gastric pH ≥4 for the 24-hour interval after the fifth dose.
Measured: 5 days
To assess whether Vecam 40/300 administered at bedtime w/o food is pharmacodynamically superior to Vecam 20/300 administered at bedtime w/o food calculated as percent time gastric pH ≥4 during nocturnal hours after the fifth dose.
Measured: 5 days
To assess whether Vecam 40/300 administered at bedtime w/o food is pharmacodynamically superior to Omeprazole 20 mg administered before breakfast calculated as percent time gastric pH ≥4 during nocturnal hours after the fifth dose
Measured: 5 days
To assess whether Vecam 20/300 administered at bedtime w/o food is pharmacodynamically superior to Omeprazole 20 mg administered before breakfast calculated as percent time gastric pH ≥4 during nocturnal hours after the fifth dose.
Measured: 5 days
To asses Vecam 40/300 administered at bedtime w/o food vs. Omeprazole 20 mg administered before breakfast calculated as percent time pH ≥4 during 24-hour interval and nocturnal hours at early dosing days.
Measured: 5 days
To assess the safety of Vecam 40/300 and Vecam 20/300 administered at bedtime vs. Omeprazole 20 mg administered before breakfast during treatment period.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2009 (estimated)
- Study startDec 2008
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vecta Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Vijayalakshmi S Pratha, MD, Principal investigator, Clinical Applications Laboratories Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00818870
- Sponsor's protocol ID
- VCT006
- Status last verified
- Jan 2010
- First submitted
- 6 Jan 2009
- Last updated
- 27 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Chowers Y, Atarot T, Pratha VS, Fass R. The effect of once daily omeprazole and succinic acid (VECAM) vs once daily omeprazole on 24-h intragastric pH. Neurogastroenterol Motil. 2012 May;24(5):426-31, e208-9. doi: 10.1111/j.1365-2982.2012.01884.x. Epub 2012 Feb 28.
PubMed 22372795
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Cross-Over, Dose-Ranging Study to Assess the Effect of Vecam 40/300 and Vecam 20/300 Administered at Bedtime Compared to Omeprazole 20 mg Administered Before Breakfast on Gastric pH
- ClinicalTrials.gov ID
- NCT00818870
- Acronym / sponsor ID
- VCT006
- Conditions
- Gastroesophageal Reflux
- Keywords
- Gastroesophageal Reflux, GERD, Nocturnal GERD, Heartburn, Nighttime Heartburn, Nocturnal Heartburn
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Vecta Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 8 Jan 2009 (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 study is designed to assess and compare the effect of Vecam 40/300, Vecam 20/300 and Omeprazole 20 mg (a standard FDA approved GERD treatment) on the control of gastric pH.
Detailed description
Eligible H. pylori negative, normal gastric acid secreting, healthy volunteers will be treated by the study medications in a randomized, open-label, cross-over study.Up to 60 volunteers may be enrolled to ensure that at least 30 subjects will complete all the study treatments. Omeprazole 20 mg will be administered before breakfast. Vecam 40/300 and Vecam 20/300 will be administered at bedtime w/o food. 24-hour gastric pH will be measured after the fifth dose (day 5).Following screening procedures, subjects will be randomly assigned to receive the different treatments.
All pH measurements will be done in the study center under supervised conditions. All drug administrations will be supervised.
This study is part of the Vecam clinical development plan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Omeprazole 20 mg | Active comparator | Drug: Omeprazole |
| Vecam 20/300 | Experimental | Drug: Vecam |
| Vecam 40/300 | Experimental | Drug: Vecam |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Healthy, H. pylori negative status (by Urea Breath Test)
- Male or female subjects
- Age 18-55 years
- Able to tolerate the placement of a nasogastric pH probe at screening
- Baseline Gastric pH≤2
Key exclusion criteria (32 listed)
- BMI > 40
- Slow or poor Omeprazole metabolizers (heterozygous or homozygous, respectively) based on CYP2C19 genotyping test.
- Any significant history of / or concurrent gastrointestinal diseases or conditions such as:
- Significant medical history or concurrent illness as determined by the principal investigator
- Any medical disorder that alters the normal gastric acid secretion profile as determined by the principal investigator
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 |
|---|---|---|
| Omeprazole20 mg capsule, orally, once daily (before breakfast) for 5 days. | Drug | Omeprazole 20 mg |
| Vecam1 capsule, orally, once daily at bedtime for 5 days. | Drug | Vecam 20/300 |
| Vecam1 capsule, orally, once daily at bedtime for 5 days. | Drug | Vecam 40/300 |
Primary outcome
To assess whether Vecam 40/300 administered at bedtime w/o food is pharmacodynamically superior to Omeprazole 20 mg administered before breakfast, calculated as percent time gastric pH ≥4 for the 24-hour interval after the fifth dose.
Time frame: 5 days
7 secondary outcomes
To assess whether Vecam 40/300 administered at bedtime w/o food is pharmacodynamically superior to Vecam 20/300 administered at bedtime w/o food calculated as percent time gastric pH ≥4 for the 24-hour interval after the fifth dose.
Time frame: 5 days
To assess whether Vecam 20/300 administered at bedtime w/o food is pharmacodynamically superior to Omeprazole 20 mg administered before breakfast, calculated as percent time gastric pH ≥4 for the 24-hour interval after the fifth dose.
Time frame: 5 days
To assess whether Vecam 40/300 administered at bedtime w/o food is pharmacodynamically superior to Vecam 20/300 administered at bedtime w/o food calculated as percent time gastric pH ≥4 during nocturnal hours after the fifth dose.
Time frame: 5 days
To assess whether Vecam 40/300 administered at bedtime w/o food is pharmacodynamically superior to Omeprazole 20 mg administered before breakfast calculated as percent time gastric pH ≥4 during nocturnal hours after the fifth dose
Time frame: 5 days
To assess whether Vecam 20/300 administered at bedtime w/o food is pharmacodynamically superior to Omeprazole 20 mg administered before breakfast calculated as percent time gastric pH ≥4 during nocturnal hours after the fifth dose.
Time frame: 5 days
To asses Vecam 40/300 administered at bedtime w/o food vs. Omeprazole 20 mg administered before breakfast calculated as percent time pH ≥4 during 24-hour interval and nocturnal hours at early dosing days.
Time frame: 5 days
To assess the safety of Vecam 40/300 and Vecam 20/300 administered at bedtime vs. Omeprazole 20 mg administered before breakfast during treatment period.
Time frame: 5 days
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 27 Jan 2010.
- Derived from this study: PubMed 22372795Chowers Y, Atarot T, Pratha VS, Fass R. The effect of once daily omeprazole and succinic acid (VECAM) vs once daily omeprazole on 24-h intragastric pH. Neurogastroenterol Motil. 2012 May;24(5):426-31, e208-9. doi: 10.1111/j.1365-2982.2012.01884.x. Epub 2012 Feb 28.
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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.
Vijayalakshmi S Pratha, MD principal investigator
Clinical Applications Laboratories Inc.
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 Omeprazole and Vecam in people with Gastroesophageal Reflux, run by Vecta Ltd. at 1 site in United States.
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 10 inclusion and 32 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 27 Jan 2010. 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 States. 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?
To assess whether Vecam 40/300 administered at bedtime w/o food is pharmacodynamically superior to Omeprazole 20 mg administered before breakfast, calculated as percent time gastric pH ≥4 for the 24-hour interval after the fifth dose. (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00818870, which also lists 1 linked publication.
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 27 Jan 2010.