Reflux EpisodesPhase 1/2NCT00813306
14473 - D9126C00001 Proof of Principle Study - Effect of AZD2066 on Transient Lower Esophageal Sphincter Relaxations
A Phase 1/2 study testing AZD2066 in people with Reflux Episodes, run by AstraZeneca at 1 site in Netherlands.
Trial summary
The purpose of the study is to assess the safety and tolerability of AZD2066 and to explore the effect of a single dose of AZD2066 on the function of the cardia (the opening between the stomach and the esophagus) compared to placebo (not containing any medical substance) in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Reflux Episodes
- What is being tested?
- AZD2066
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- Dec 2008to Nov 2009
- Phase
- Phase 1/2
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provision of written consent prior to any study specific procedures.
- Healthy subjects, age 18-45 years inclusive. Females must be of no childbearing potential or must use a highly effective contraceptive method.
- Clinically normal physical findings and laboratory values at the time of pre-entry visit, as judged by the investigator.
Who cannot join
- Clinically significant illness within the 2 weeks prior to the first dose of the investigational product, including a suspected/manifested infection according to WHO risk categories 2, 3 or 4, as judged by the investigator.
- A measured LES pressure of < 5mm Hg.
- History of previous or ongoing psychiatric disease/condition.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Randomized, Placebo-controlled, Single-centre Phase I Pharmacodynamic Cross-over Study to Assess the Effect of a Single Dose of AZD2066 Oral Solution in Comparison to Placebo on Transient Lower Esophageal Sphincter Relaxations (TLESRs) in Healthy Subjects
The purpose of the study is to assess the safety and tolerability of AZD2066 and to explore the effect of a single dose of AZD2066 on the function of the cardia (the opening between the stomach and the esophagus) compared to placebo (not containing any medical substance) in healthy volunteers.
- Conditions
- Reflux Episodes
- Being tested
- AZD2066, Placebo
- Keywords
- GERD, TLESR, reflux
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD2066Drug
13 mg oral solution, 1 single dose
PlaceboDrug
Oral solution, 1 single dose
AZD2066Drug
Dose to be decided after Part A, including dose A (active) and B (placebo). Oral solution, 1 single dose
AZD2066Drug
Dose to be decided after Part A, including dose A (active) and B (placebo). Oral solution, 1 single dose
PlaceboDrug
Oral solution, 1 single dose
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | AZD2066 Receives: Drug: AZD2066 |
| B | Placebo comparator | Placebo Receives: Drug: Placebo |
| C | Experimental | AZD2066 Receives: Drug: AZD2066 |
| D | Experimental | AZD2066 Receives: Drug: AZD2066 |
| E | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Manometry
Measured: 3.45 hours each study period
Secondary outcomes (3)
pH
Measured: 3.45 hours each study period
Impedance
Measured: 3.45 hours each study period
Pharmacokinetic variables
Measured: 3.45 hours each study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2008 (estimated)
- Study startDec 2008
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reflux EpisodesStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Marie Sundin, Study director, AstraZeneca R&D, Mölndal, SwedenGuy E Boeckxstaens, MD, PhD, Principal investigator, Motiliteitscentrum (C2-310)Department of Gastroenterology,Academic Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00813306
- Sponsor's protocol ID
- D9126C00001
- Status last verified
- Dec 2010
- First submitted
- 22 Dec 2008
- Last updated
- 7 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-controlled, Single-centre Phase I Pharmacodynamic Cross-over Study to Assess the Effect of a Single Dose of AZD2066 Oral Solution in Comparison to Placebo on Transient Lower Esophageal Sphincter Relaxations (TLESRs) in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00813306
- Acronym / sponsor ID
- D9126C00001
- Conditions
- Reflux Episodes
- Keywords
- GERD, TLESR, reflux
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Study completion
- Nov 2009 (actual)
- First posted
- 23 Dec 2008 (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 the study is to assess the safety and tolerability of AZD2066 and to explore the effect of a single dose of AZD2066 on the function of the cardia (the opening between the stomach and the esophagus) compared to placebo (not containing any medical substance) in healthy volunteers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: AZD2066AZD2066 |
| B | Placebo comparator | Drug: PlaceboPlacebo |
| C | Experimental | Drug: AZD2066AZD2066 |
| D | Experimental | Drug: AZD2066AZD2066 |
| E | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Provision of written consent prior to any study specific procedures.
- Healthy subjects, age 18-45 years inclusive. Females must be of no childbearing potential or must use a highly effective contraceptive method.
- Clinically normal physical findings and laboratory values at the time of pre-entry visit, as judged by the investigator.
Key exclusion criteria (3 listed)
- Clinically significant illness within the 2 weeks prior to the first dose of the investigational product, including a suspected/manifested infection according to WHO risk categories 2, 3 or 4, as judged by the investigator.
- A measured LES pressure of < 5mm Hg.
- History of previous or ongoing psychiatric disease/condition.
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 |
|---|---|---|
| AZD206613 mg oral solution, 1 single dose | Drug | A |
| PlaceboOral solution, 1 single dose | Drug | B |
| AZD2066Dose to be decided after Part A, including dose A (active) and B (placebo). Oral solution, 1 single dose | Drug | C |
| AZD2066Dose to be decided after Part A, including dose A (active) and B (placebo). Oral solution, 1 single dose | Drug | D |
| PlaceboOral solution, 1 single dose | Drug | E |
Primary outcome
Manometry
Time frame: 3.45 hours each study period
3 secondary outcomes
pH
Time frame: 3.45 hours each study period
Impedance
Time frame: 3.45 hours each study period
Pharmacokinetic variables
Time frame: 3.45 hours each study period
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 7 Dec 2010.
Related trials for Reflux Episodes
RecruitingObservational study
Efficacy and Safety of Esomeprazole 40 mg IV in Post-Surgical Patients Admitted to the ICU
Stress Ulcers, Reflux Episodes
RecruitingObservational study
Normal Values of Ambulatory 24-hour Oesophageal pH-impedance Monitoring in an Indian Cohort of Participants
GERD (Gastroesophageal Reflux Disease)
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.
Marie Sundin study director
AstraZeneca R&D, Mölndal, Sweden
Guy E Boeckxstaens, MD, PhD principal investigator
Motiliteitscentrum (C2-310)Department of Gastroenterology,Academic Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AZD2066 in people with Reflux Episodes, run by AstraZeneca at 1 site in Netherlands.
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 3 inclusion and 3 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 7 Dec 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 Netherlands. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
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?
Manometry (time frame: 3.45 hours each study period). 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 7 Dec 2010.