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 - NCT01059383(Clinical Trial 481183)
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Oklahoma City |
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State:
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OK |
| Zip Code: |
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73104 |
| Conditions: |
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Gastroesophageal Reflux |
| Purpose: |
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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.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
- 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:
- 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
Exclusion Criteria:
- 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
- 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. |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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August 16, 2010 |
Modifications to
this listing: |
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above to view all information about this clinical trial. |
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