EsophagitisPhase 1NCT00284908
Dose-Effect of S-Tenatoprazole-Na(STU-Na) 30 mg, 60 mg, 90 mg and 120 mg in Healthy Volunteers
A Phase 1 study testing S-Tenatoprazole-Na (STU-Na) in people with Esophagitis and Gastroesophageal Reflux, run by STEBA France at 1 site in United States.
Trial summary
S-Tenatoprazole-Na (STU-Na), a new drug currently under clinical development, belongs to a class of drugs, called proton pump inhibitors (PPls). Some PPIs are already commercially available. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Esophagitis, Gastroesophageal Reflux, Stomach Ulcer
- What is being tested?
- S-Tenatoprazole-Na (STU-Na)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Nov 2006
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteers aged 18 to 55 years inclusive
- Able to understand the nature of the study and to give written informed consent
- Able to communicate well with the investigator himself or his/her representatives
- Able not to smoke during each hospitalization
- Normal physical examination at the screening visit
- Body Mass Index between 18 kg/m² and 35 kg/m² at the screening visit
Show all 9Show fewer
- Normal blood pressure and heart rate measured under standardized conditions at the screening visit after at least 5 minutes of rest in a supine position: SBP within 90 and 140 mmHg, DBP within 40 and 85 mmHg, and HR within 40 to 85 bpm
- Normal 12-lead electrocardiogram at screening visit recorded after at least 5 minutes of rest: PR within 120 and 200 ms, QRS below or equal to 120 ms, and QTc below or equal to 440 ms
- Laboratory results within the normal ranges or considered not being of clinical relevance by the investigator
Who cannot join
- Vegetarians
- Positive to H. pylori by 13C urea breath test or stool antigen test at screening visit
- Contra-indication to proton pump inhibitors treatment
- Previous participation in a trial with PPIs within 3 months
- Current or historical evidence of clinically relevant cardiovascular, neurological, hematological, hepatic, gastrointestinal, renal, pulmonary, endocrinological, metabolic or psychiatric disease
- Any other acute or chronic disease which could influence the volunteer's health and/or the study results
Show all 18Show fewer
- Presence or history of malabsorption or any gastrointestinal surgery except appendectomy or hernia repair
- Receipt of medication (including 'over the counter' preparations) within two weeks of dosing
- Use of enzyme inducers or enzyme inhibitor drugs within the last three months before the first drug administration
- Participation in a clinical trial involving receipt of a licensed (marketed) medicinal product or of an unlicensed (investigational) medicinal product within one month before the study
- Past or current drug exposure amounting to drug abuse or addiction
- Past or current alcohol exposure amounting to alcohol abuse or addiction; (i.e. > 28 units per week for males, where 1 unit = one measure of spirit (25 mL), one glass of wine (125 mL) or ½ pint beer)
- Currently smoke >10 cigarettes per day
- Donation of blood or any other major blood loss (>500 mL) within three months before the study
- Unwilling or unable to comply with the study protocol for any reason or in the opinion of the investigator should not participate in the study
- Positive test for hepatitis B surface antigen, hepatitis C antibody, HIV1 or HIV2 antibody at screening
- Known allergy or intolerance to lactose
- Known allergy or intolerance to any other compound in the study drug or any other closely related compound
Trial locations and contacts
1 site in 1 country.
United States1 site
Healthcare Discoveries, Inc.
San Antonio, Texas, 78229
About this study
Official title: Pharmacodynamic Dose-Response of S-Tenatoprazole-Na (STU-Na) 30 mg, 60 mg, 90 mg and 120 mg in Healthy Volunteers
S-Tenatoprazole-Na (STU-Na), a new drug currently under clinical development, belongs to a class of drugs, called proton pump inhibitors (PPls). Some PPIs are already commercially available. STU-Na will be used for treatment of acid related diseases (gastroduodenal ulcers, erosive or ulcerative esophagitis due to gastroesophageal reflux disease). This study evaluates the degree of acid suppression by different doses of STU-Na. The degree of acid suppression is considered to be correlated with clinical efficacy.
In this study four dosages of STU-Na (30 mg, 60 mg, 90 mg, and 120 mg) will be tested in each volunteer. First, one of the dosages will be orally administered for five days. Then, a nine to sixteen day period without study drug administration will follow prior to the administration of the next dosage, for again five days. Each volunteer will have a total of four study drug administration periods.
Read more
After the last study drug intake in period 1, 2 and 3 pharmacokinetic blood sampling will be done for four days. After the last study drug intake in period 4 pharmacokinetic blood sampling will be done for five days. Pharmacokinetic blood sampling consists of several blood draws over a pre-determined time period. The pharmacokinetic blood sampling measures the medication concentration in the blood at pre-defined time points.
After the last study drug intake in period 1, 2, 3, and 4, gastric acidity will be measured for 24 hours by means of a thin tube that will be inserted into the stomach through the nostril to evaluate the efficacy of the different dosages of STU-Na.
Read the detailed description
S-Tenatoprazole-Na (STU-Na), a new drug currently under clinical development, belongs to a class of drugs, called proton pump inhibitors (PPls). Some PPIs are already commercially available. STU-Na will be used for treatment of acid related diseases (gastroduodenal ulcers, erosive or ulcerative esophagitis due to gastroesophageal reflux disease). This study evaluates the degree of acid suppression by different doses of STU-Na. The degree of acid suppression is considered to be correlated with clinical efficacy.
In this study four dosages of STU-Na (30 mg, 60 mg, 90 mg, and 120 mg) will be tested in each volunteer. First, one of the dosages will be orally administered for five days. Then, a nine to sixteen day period without study drug administration will follow prior to the administration of the next dosage, for again five days. Each volunteer will have a total of four study drug administration periods.
After the last study drug intake in period 1, 2 and 3 pharmacokinetic blood sampling will be done for four days. After the last study drug intake in period 4 pharmacokinetic blood sampling will be done for five days. Pharmacokinetic blood sampling consists of several blood draws over a pre-determined time period. The pharmacokinetic blood sampling measures the medication concentration in the blood at pre-defined time points.
After the last study drug intake in period 1, 2, 3, and 4, gastric acidity will be measured for 24 hours by means of a thin tube that will be inserted into the stomach through the nostril to evaluate the efficacy of the different dosages of STU-Na.
- Conditions
- Esophagitis, Gastroesophageal Reflux, Stomach Ulcer, Duodenal Ulcer
- Being tested
- S-Tenatoprazole-Na (STU-Na)
- Keywords
- S-Tenatoprazole-Na, Pharmacokinetic, intragastric pH recording, dose-response
- Medical subject headings
- Esophagitis, Gastroesophageal Reflux, Stomach Ulcer, Duodenal Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-Tenatoprazole-Na (STU-Na)Drug
30 mg, 60 mg, 90 mg and 120 mg of STU-Na for 5 days every morning
| Study group | Role | What they receive |
|---|---|---|
| I STU-Na | Experimental | Cross-over study with escalating doses Receives: Drug: S-Tenatoprazole-Na (STU-Na) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intragastric pH recording for 24 hours after 5 days of treatment
Measured: Beginning of the pH recording before the last study drug intake in each period
Secondary outcomes (1)
Pharmacokinetic blood sampling at steady state
Measured: Blood sampling begins before the intake of the last study drug in each period and lasts for 96 hours (periods 1 to 3) or 120 hours (period 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2006 (estimated)
- Study startSep 2006
- Primary completionNov 2006
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for EsophagitisStudies 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- STEBA France
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- STEBA LABORATORIES LTD.
- Investigators
- Dennis A Ruff, MD, Principal investigator, Healthcare Discoveries Inc.Patrick Cohen, MD, Study director, STEBA FranceChristof Kreutz, MD, Study director, STEBA France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00284908
- Sponsor's protocol ID
- HPD/STU(-Na) 05819N/TU 1.41
- Status last verified
- Mar 2008
- First submitted
- 31 Jan 2006
- Last updated
- 24 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Burget DW, Chiverton SG, Hunt RH. Is there an optimal degree of acid suppression for healing of duodenal ulcers? A model of the relationship between ulcer healing and acid suppression. Gastroenterology. 1990 Aug;99(2):345-51. doi: 10.1016/0016-5085(90)91015-x.
PubMed 2142113DeVault KR, Castell DO. Updated guidelines for the diagnosis and treatment of gastroesophageal reflux disease. The Practice Parameters Committee of the American College of Gastroenterology. Am J Gastroenterol. 1999 Jun;94(6):1434-42. doi: 10.1111/j.1572-0241.1999.1123_a.x. No abstract available.
PubMed 10364004Armstrong D. Review article: gastric pH -- the most relevant predictor of benefit in reflux disease? Aliment Pharmacol Ther. 2004 Oct;20 Suppl 5:19-26; discussion 38-9. doi: 10.1111/j.1365-2036.2004.02140.x.
PubMed 15456460Bell NJ, Burget D, Howden CW, Wilkinson J, Hunt RH. Appropriate acid suppression for the management of gastro-oesophageal reflux disease. Digestion. 1992;51 Suppl 1:59-67. doi: 10.1159/000200917.
PubMed 1397746Galmiche JP, Bruley Des Varannes S, Ducrotte P, Sacher-Huvelin S, Vavasseur F, Taccoen A, Fiorentini P, Homerin M. Tenatoprazole, a novel proton pump inhibitor with a prolonged plasma half-life: effects on intragastric pH and comparison with esomeprazole in healthy volunteers. Aliment Pharmacol Ther. 2004 Mar 15;19(6):655-62. doi: 10.1111/j.1365-2036.2004.01893.x.
PubMed 15023167Horn J. The proton-pump inhibitors: similarities and differences. Clin Ther. 2000 Mar;22(3):266-80; discussion 265. doi: 10.1016/S0149-2918(00)80032-6.
PubMed 10963283Kakinoki B, Ono C, Yamazaki N, Chikamatsu N, Wakatsuki D, Uchiyama K, Morinaka Y. General pharmacological properties of the new proton pump inhibitor (+/-)-5-methoxy-2-[[(4-methoxy-3,5-dimethylpyrid-2-yl)methyl]sulf inyl]- 1H-imidazo[4,5-b]pyridine. Methods Find Exp Clin Pharmacol. 1999 Apr;21(3):179-87. doi: 10.1358/mf.1999.21.3.534827.
PubMed 10389120Katz PO, Castell DO, Chen Y, Andersson T, Sostek MB. Intragastric acid suppression and pharmacokinetics of twice-daily esomeprazole: a randomized, three-way crossover study. Aliment Pharmacol Ther. 2004 Aug 15;20(4):399-406. doi: 10.1111/j.1365-2036.2004.02079.x.
PubMed 15298633Kromer W, Horbach S, Luhmann R. Relative efficacies of gastric proton pump inhibitors: their clinical and pharmacological basis. Pharmacology. 1999 Aug;59(2):57-77. doi: 10.1159/000028306.
PubMed 10450061Lundell LR, Dent J, Bennett JR, Blum AL, Armstrong D, Galmiche JP, Johnson F, Hongo M, Richter JE, Spechler SJ, Tytgat GN, Wallin L. Endoscopic assessment of oesophagitis: clinical and functional correlates and further validation of the Los Angeles classification. Gut. 1999 Aug;45(2):172-80. doi: 10.1136/gut.45.2.172.
PubMed 10403727Revicki DA, Crawley JA, Zodet MW, Levine DS, Joelsson BO. Complete resolution of heartburn symptoms and health-related quality of life in patients with gastro-oesophageal reflux disease. Aliment Pharmacol Ther. 1999 Dec;13(12):1621-30. doi: 10.1046/j.1365-2036.1999.00669.x.
PubMed 10594397Stedman CA, Barclay ML. Review article: comparison of the pharmacokinetics, acid suppression and efficacy of proton pump inhibitors. Aliment Pharmacol Ther. 2000 Aug;14(8):963-78. doi: 10.1046/j.1365-2036.2000.00788.x.
PubMed 10930890Uchiyama K, Wakatsuki D, Kakinoki B, Takeuchi Y, Araki T, Morinaka Y. The long-lasting effect of TU-199, a novel H+, K(+)-ATPase inhibitor, on gastric acid secretion in dogs. J Pharm Pharmacol. 1999 Apr;51(4):457-64. doi: 10.1211/0022357991772510.
PubMed 10385219
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacodynamic Dose-Response of S-Tenatoprazole-Na (STU-Na) 30 mg, 60 mg, 90 mg and 120 mg in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00284908
- Acronym / sponsor ID
- HPD/STU(-Na) 05819N/TU 1.41
- Conditions
- Esophagitis, Gastroesophageal Reflux, Stomach Ulcer, Duodenal Ulcer
- Keywords
- S-Tenatoprazole-Na, Pharmacokinetic, intragastric pH recording, dose-response
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- STEBA FranceIndustry (pharma, biotech, devices)
- Collaborators
- STEBA LABORATORIES LTD.
- Study start
- Sep 2006
- Primary completion
- Nov 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 1 Feb 2006 (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.
S-Tenatoprazole-Na (STU-Na), a new drug currently under clinical development, belongs to a class of drugs, called proton pump inhibitors (PPls). Some PPIs are already commercially available. STU-Na will be used for treatment of acid related diseases (gastroduodenal ulcers, erosive or ulcerative esophagitis due to gastroesophageal reflux disease). This study evaluates the degree of acid suppression by different doses of STU-Na. The degree of acid suppression is considered to be correlated with clinical efficacy.
In this study four dosages of STU-Na (30 mg, 60 mg, 90 mg, and 120 mg) will be tested in each volunteer. First, one of the dosages will be orally administered for five days. Then, a nine to sixteen day period without study drug administration will follow prior to the administration of the next dosage, for again five days. Each volunteer will have a total of four study drug administration periods.
After the last study drug intake in period 1, 2 and 3 pharmacokinetic blood sampling will be done for four days. After the last study drug intake in period 4 pharmacokinetic blood sampling will be done for five days. Pharmacokinetic blood sampling consists of several blood draws over a pre-determined time period. The pharmacokinetic blood sampling measures the medication concentration in the blood at pre-defined time points.
After the last study drug intake in period 1, 2, 3, and 4, gastric acidity will be measured for 24 hours by means of a thin tube that will be inserted into the stomach through the nostril to evaluate the efficacy of the different dosages of STU-Na.
Detailed description
S-Tenatoprazole-Na (STU-Na), a new drug currently under clinical development, belongs to a class of drugs, called proton pump inhibitors (PPls). Some PPIs are already commercially available. STU-Na will be used for treatment of acid related diseases (gastroduodenal ulcers, erosive or ulcerative esophagitis due to gastroesophageal reflux disease). This study evaluates the degree of acid suppression by different doses of STU-Na. The degree of acid suppression is considered to be correlated with clinical efficacy.
In this study four dosages of STU-Na (30 mg, 60 mg, 90 mg, and 120 mg) will be tested in each volunteer. First, one of the dosages will be orally administered for five days. Then, a nine to sixteen day period without study drug administration will follow prior to the administration of the next dosage, for again five days. Each volunteer will have a total of four study drug administration periods.
After the last study drug intake in period 1, 2 and 3 pharmacokinetic blood sampling will be done for four days. After the last study drug intake in period 4 pharmacokinetic blood sampling will be done for five days. Pharmacokinetic blood sampling consists of several blood draws over a pre-determined time period. The pharmacokinetic blood sampling measures the medication concentration in the blood at pre-defined time points.
After the last study drug intake in period 1, 2, 3, and 4, gastric acidity will be measured for 24 hours by means of a thin tube that will be inserted into the stomach through the nostril to evaluate the efficacy of the different dosages of STU-Na.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| I STU-Na | Experimental | Drug: S-Tenatoprazole-Na (STU-Na)Cross-over study with escalating doses |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy male volunteers aged 18 to 55 years inclusive
- Able to understand the nature of the study and to give written informed consent
- Able to communicate well with the investigator himself or his/her representatives
- Able not to smoke during each hospitalization
- Normal physical examination at the screening visit
Key exclusion criteria (18 listed)
- Vegetarians
- Positive to H. pylori by 13C urea breath test or stool antigen test at screening visit
- Contra-indication to proton pump inhibitors treatment
- Previous participation in a trial with PPIs within 3 months
- Current or historical evidence of clinically relevant cardiovascular, neurological, hematological, hepatic, gastrointestinal, renal, pulmonary, endocrinological, metabolic or psychiatric disease
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 |
|---|---|---|
| S-Tenatoprazole-Na (STU-Na)30 mg, 60 mg, 90 mg and 120 mg of STU-Na for 5 days every morning | Drug | I STU-Na |
Primary outcome
Intragastric pH recording for 24 hours after 5 days of treatment
Time frame: Beginning of the pH recording before the last study drug intake in each period
1 secondary outcome
Pharmacokinetic blood sampling at steady state
Time frame: Blood sampling begins before the intake of the last study drug in each period and lasts for 96 hours (periods 1 to 3) or 120 hours (period 4)
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 24 Mar 2008.
- Background: PubMed 2142113Burget DW, Chiverton SG, Hunt RH. Is there an optimal degree of acid suppression for healing of duodenal ulcers? A model of the relationship between ulcer healing and acid suppression. Gastroenterology. 1990 Aug;99(2):345-51. doi: 10.1016/0016-5085(90)91015-x.
- Background: PubMed 10364004DeVault KR, Castell DO. Updated guidelines for the diagnosis and treatment of gastroesophageal reflux disease. The Practice Parameters Committee of the American College of Gastroenterology. Am J Gastroenterol. 1999 Jun;94(6):1434-42. doi: 10.1111/j.1572-0241.1999.1123_a.x. No abstract available.
- Background: PubMed 15456460Armstrong D. Review article: gastric pH -- the most relevant predictor of benefit in reflux disease? Aliment Pharmacol Ther. 2004 Oct;20 Suppl 5:19-26; discussion 38-9. doi: 10.1111/j.1365-2036.2004.02140.x.
- Background: PubMed 1397746Bell NJ, Burget D, Howden CW, Wilkinson J, Hunt RH. Appropriate acid suppression for the management of gastro-oesophageal reflux disease. Digestion. 1992;51 Suppl 1:59-67. doi: 10.1159/000200917.
- Background: PubMed 15023167Galmiche JP, Bruley Des Varannes S, Ducrotte P, Sacher-Huvelin S, Vavasseur F, Taccoen A, Fiorentini P, Homerin M. Tenatoprazole, a novel proton pump inhibitor with a prolonged plasma half-life: effects on intragastric pH and comparison with esomeprazole in healthy volunteers. Aliment Pharmacol Ther. 2004 Mar 15;19(6):655-62. doi: 10.1111/j.1365-2036.2004.01893.x.
- Background: PubMed 10963283Horn J. The proton-pump inhibitors: similarities and differences. Clin Ther. 2000 Mar;22(3):266-80; discussion 265. doi: 10.1016/S0149-2918(00)80032-6.
- Background: PubMed 10389120Kakinoki B, Ono C, Yamazaki N, Chikamatsu N, Wakatsuki D, Uchiyama K, Morinaka Y. General pharmacological properties of the new proton pump inhibitor (+/-)-5-methoxy-2-[[(4-methoxy-3,5-dimethylpyrid-2-yl)methyl]sulf inyl]- 1H-imidazo[4,5-b]pyridine. Methods Find Exp Clin Pharmacol. 1999 Apr;21(3):179-87. doi: 10.1358/mf.1999.21.3.534827.
- Background: PubMed 15298633Katz PO, Castell DO, Chen Y, Andersson T, Sostek MB. Intragastric acid suppression and pharmacokinetics of twice-daily esomeprazole: a randomized, three-way crossover study. Aliment Pharmacol Ther. 2004 Aug 15;20(4):399-406. doi: 10.1111/j.1365-2036.2004.02079.x.
- Background: PubMed 10450061Kromer W, Horbach S, Luhmann R. Relative efficacies of gastric proton pump inhibitors: their clinical and pharmacological basis. Pharmacology. 1999 Aug;59(2):57-77. doi: 10.1159/000028306.
- Background: PubMed 10403727Lundell LR, Dent J, Bennett JR, Blum AL, Armstrong D, Galmiche JP, Johnson F, Hongo M, Richter JE, Spechler SJ, Tytgat GN, Wallin L. Endoscopic assessment of oesophagitis: clinical and functional correlates and further validation of the Los Angeles classification. Gut. 1999 Aug;45(2):172-80. doi: 10.1136/gut.45.2.172.
- Background: PubMed 10594397Revicki DA, Crawley JA, Zodet MW, Levine DS, Joelsson BO. Complete resolution of heartburn symptoms and health-related quality of life in patients with gastro-oesophageal reflux disease. Aliment Pharmacol Ther. 1999 Dec;13(12):1621-30. doi: 10.1046/j.1365-2036.1999.00669.x.
- Background: PubMed 10930890Stedman CA, Barclay ML. Review article: comparison of the pharmacokinetics, acid suppression and efficacy of proton pump inhibitors. Aliment Pharmacol Ther. 2000 Aug;14(8):963-78. doi: 10.1046/j.1365-2036.2000.00788.x.
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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.
Dennis A Ruff, MD principal investigator
Healthcare Discoveries Inc.
Patrick Cohen, MD study director
STEBA France
Christof Kreutz, MD study director
STEBA France
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 S-Tenatoprazole-Na (STU-Na) in people with Esophagitis and Gastroesophageal Reflux, run by STEBA France 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 9 inclusion and 18 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 24 Mar 2008. 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?
Intragastric pH recording for 24 hours after 5 days of treatment (time frame: Beginning of the pH recording before the last study drug intake in each period). 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 NCT00284908, which also lists 13 linked publications.
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 24 Mar 2008.