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Gastroesophageal RefluxPhase 2NCT01059383

Active Control, Double-blind, Double-dummy, Parallel-group, Randomized Study to Assess the Effect of VECAM 40/300, Administered at Bedtime, vs. Esomeprazole 20 mg, Administered 30-60 Min. Before Dinner, on Daytime and Nighttime GERD Symptoms

A Phase 2 study testing VECAM 40/300 and Esomeprazole 20 mg in people with Gastroesophageal Reflux, run by Vecta Ltd. at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study is designed to assess the effect and safety of oral administration of VECAM 40/300 administered at bedtime compared to Esomeprazole 20 mg administered 30-60 minutes before dinner, for control of nighttime and daytime HB and other 24 hour GERD symptoms. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Gastroesophageal Reflux
What is being tested?
VECAM 40/300 and Esomeprazole 20 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
2 sitesUnited States
Study dates
Dec 2009to Jun 2011
Phase
Phase 2
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18-75 years
  • Male or female
  • H. pylori negative status
  • Suffering from nighttime and daytime heartburn for the last ≥3 months
  • At least 28 days of PPI use prior to study entry
  • Patients have to be current PPI users with either:
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  • Category 1): ≥ 2 HB episodes in 7 consecutive days, at least one during the nighttime to approved PPI doses, or
  • Category 2): only obtaining complete relief of GERD symptoms following the addition of acid suppressive agents (e.g. H2RA, additional PPI dose), or antacid therapy, to the approved PPI dose.
  • Reporting of ≥ 3 HB episodes in 7 consecutive days, at least two during the nighttime, w/o medical treatment during a screening period of up to 21 days (report is based on a daily diary during the screening period) and for Category 1 patients, at least one more HB episode as compared to single dose treatment period.
  • Use of acceptable form of birth control in females with child-bearing potential
  • Can swallow a size "00" capsule without difficulty
  • Willing to comply with study protocol
  • Understood and signed an informed consent form for this study

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 including:
  • Acute gastrointestinal bleeding. or history of GI bleeding within 6 months prior to randomization
  • Zollinger Ellison Syndrome or Gastric hypersecretory condition
  • Esophageal stricture
Show all 47Show fewer
  • Active gastric or duodenal ulcers within 30 days prior to randomization
  • Gastric outlet obstruction
  • Gastro-paresis or gastric emptying disorder
  • Significant hepatic disease: cirrhosis or hepatic encephalopathy
  • Any significant medical co-morbidity that precludes participation in the study or can affect acid secretion, or sleep as judged by the investigator
  • Significant laboratory abnormalities as determined by the principal investigator.
  • Known metabolic alkalosis, hypocalcemia, sodium restricted diet, hypokalemia, or respiratory alkalosis.
  • Had been treated with any investigational drug or therapy or participated in a clinical trial within 30 days prior to entering the trial.
  • Active or illicit drug or alcohol abuse
  • Use of any medication that alters gastric acid secretion other than the study medications provided by the study personnel.
  • Regular use (>3 doses per week) of non-steroidal anti-inflammatory drugs (NSAIDs), including COX 2 inhibitors within 30 days prior to randomization or during the study.
  • Use of the following medications during the study:
  • Bismuth-containing products
  • Antibiotics
  • Sucralfate
  • Misoprostol
  • Corticosteroids
  • Prokinetic agents
  • Anticoagulant therapy
  • Antiseizure medications
  • Psychotropic medications
  • Narcotic medications
  • Bisphosphonates
  • Anti-neoplastic treatments
  • Use of sleep medications:
  • First generation antihistamines
  • Benzodiazepines
  • Modified cyclic antidepressants
  • Antianxiety medications
  • Unless dose remains unchanged throughout the study, drugs with significant anticholinergic effects such as tricyclic antidepressants or drugs with CNS effects that could mask perception of symptoms (e.g., SSRIs*, SNRIs**).
  • Unless consumed during the screening period per protocol instructions:
  • Proton pump inhibitors (other than the study medication)
  • Histamine (H2) receptor antagonists
  • Any conditions other than GERD that could be the primary cause of significant sleep disturbances (including but not limited to anxiety, depression, panic attacks, sleep apnea, chronic obstructive pulmonary disease requiring oxygen therapy or that are known to disrupt patients sleep, chronic insomnia, excessive use of caffeine), nocturnal urination
  • 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
  • Significant drug allergy or known hypersensitivity to: any proton pump inhibitor drug , or ingredients in the study medications (Omeprazole, Succinic Acid) or their inactive ingredients contained in their capsule, or to Gelusil® tablets
  • Had donated blood within 30 days of entering the trial
  • Known positive serology for HBV, HCV or HIV
  • Diabetes
  • Any reason that makes the patient a poor candidate based on the study physician, or PI's discretion.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Oklahoma Foundation for Digestive Research

    Oklahoma City, Oklahoma, 73104

  • Clinical Applications Laboratories Inc.

    San Diego, California, 92103

Other trials in United States

About this study

The study is designed to assess the effect and safety of oral administration of VECAM 40/300 administered at bedtime compared to Esomeprazole 20 mg administered 30-60 minutes before dinner, for control of nighttime and daytime HB and other 24 hour GERD symptoms.

The rational for the study is based on the contention that VECAM exhibits potent inhibition of acid secretion and because of its mechanism of action, it can be administered at bedtime without food. Such timing of drug dosing will allow effective inhibition of nighttime acid secretion. Because of its mechanism of action, VECAM exhibits improved 24-hour inhibition of acid secretion and hence, its bedtime administration will not compromise its effect during the daytime. This improved control of acid secretion will predictably result in better control of nighttime as well as daytime heartburn (HB) symptoms.

Being tested
VECAM 40/300, Esomeprazole 20 mg
Keywords
Gastroesophageal Reflux, GERD, Nocturnal GERD, Heartburn, Nighttime 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.

  • VECAM 40/300Drug

    1 capsule, orally, once daily at bedtime.

  • Esomeprazole 20 mgDrug

    1 capsule, orally, once daily 30-60 min. before dinner

Study groups in NCT01059383
Study groupRoleWhat they receive
VECAM 40/300ExperimentalNot described
Receives: Drug: VECAM 40/300
Esomeprazole 20 mgActive comparatorNot described
Receives: Drug: Esomeprazole 20 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of days with neither daytime nor nighttime heartburn during week 1, 2, 3, 4 and the overall treatment period measured with a patient-reported HB daily diary

    Measured: 4 weeks

Secondary outcomes (2)

  1. Complete resolution of nighttime and daytime HB during the subject's last 7 diary reported days in the study,

    Measured: 4 weeks

  2. Percentage of days without nighttime HB on week 1, 2, 3, 4 and the overall treatment period, measured with a patient-reported HB daily diary.

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2010 (estimated)
  2. Study startDec 2009
  3. Primary completionJun 2011
  4. Study completionJun 2011

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01059383
Sponsor's protocol ID
VCT007
Status last verified
Jul 2012
First submitted
28 Jan 2010
Last updated
30 Jul 2012
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing VECAM 40/300 and Esomeprazole 20 mg in people with Gastroesophageal Reflux, run by Vecta Ltd. at 2 sites 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 13 inclusion and 47 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 30 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 days with neither daytime nor nighttime heartburn during week 1, 2, 3, 4 and the overall treatment period measured with a patient-reported HB daily diary (time frame: 4 weeks). 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 NCT01059383.

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 30 Jul 2012.

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