Gastroesophageal Reflux DiseasePhase 1NCT00688402
Study to Compare Different Formulations of AZD3355
A Phase 1 study testing AZD3355 in people with Gastroesophageal Reflux Disease, run by AstraZeneca at 1 site in Sweden.
Trial summary
The purpose of the study is to compare different formulations of AZD3355 in regard to possible adverse events such as sensations of numbness, tinglings and heat in the skin. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastroesophageal Reflux Disease
- What is being tested?
- AZD3355
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2008to Jun 2008
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provision of written informed consent
- Female subjects with no childbearing potentials or using highly efficient contraceptive methods
- Clinically normal physical findings
Who cannot join
- Clinically significant illness within 2 weeks prior to the first dose of investigational product
- History of clinically significant disease
- Use of prescribed medication during the 2 weeks before administration of the first dose of investigational product
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Randomized, Cross-over Design, Phase 1 Pharmacodynamic Study to Investigate the Effect of Different Formulations of AZD3355 for the Development of Paresthesiae After Dosing in Healthy Subjects
The purpose of the study is to compare different formulations of AZD3355 in regard to possible adverse events such as sensations of numbness, tinglings and heat in the skin.
- Conditions
- Gastroesophageal Reflux Disease
- Being tested
- AZD3355
- Keywords
- Reflux Inhibitor, GERD, formulations
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD3355Drug
Also called Lesogaberan
Single dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | IR Formulation 65 mg Receives: Drug: AZD3355 |
| 2 | Experimental | IR Formulation 150 mg Receives: Drug: AZD3355 |
| 3 | Experimental | MR formulation, 1h 65 mg Receives: Drug: AZD3355 |
| 4 | Experimental | MR Formulation, 1h 150 mg Receives: Drug: AZD3355 |
| 5 | Experimental | MR Formulation, 2h 150 mg Receives: Drug: AZD3355 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specific AE questions
Measured: During 0-4 hours post dose
Secondary outcomes (2)
PK variables
Measured: Frequent sampling up to 36 hours post dose
Safety variables (other adverse events, blood pressure, pulse, safety lab)
Measured: During the whole treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2008 (estimated)
- Study startApr 2008
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux DiseaseStudies 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Eva Ersdal, PhD, Study director, AstraZeneca R&D, Mölndal, SwedenAslak Rautio, MD, Principal investigator, Quintiles Hermelinen, Varvsgatan 53, SE-972 33 Luleå, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00688402
- Sponsor's protocol ID
- D9120C00031
- Other IDs
- EudraCT nr 2007-007126-22
- Status last verified
- Dec 2010
- First submitted
- 30 May 2008
- Last updated
- 3 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Cross-over Design, Phase 1 Pharmacodynamic Study to Investigate the Effect of Different Formulations of AZD3355 for the Development of Paresthesiae After Dosing in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00688402
- Acronym / sponsor ID
- D9120C00031
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- Reflux Inhibitor, GERD, formulations
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 3 Jun 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 compare different formulations of AZD3355 in regard to possible adverse events such as sensations of numbness, tinglings and heat in the skin.
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 |
|---|---|---|
| 1 | Experimental | Drug: AZD3355IR Formulation 65 mg |
| 2 | Experimental | Drug: AZD3355IR Formulation 150 mg |
| 3 | Experimental | Drug: AZD3355MR formulation, 1h 65 mg |
| 4 | Experimental | Drug: AZD3355MR Formulation, 1h 150 mg |
| 5 | Experimental | Drug: AZD3355MR Formulation, 2h 150 mg |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Provision of written informed consent
- Female subjects with no childbearing potentials or using highly efficient contraceptive methods
- Clinically normal physical findings
Key exclusion criteria (3 listed)
- Clinically significant illness within 2 weeks prior to the first dose of investigational product
- History of clinically significant disease
- Use of prescribed medication during the 2 weeks before administration of the first dose of investigational product
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 |
|---|---|---|
| AZD3355Also: LesogaberanSingle dose | Drug | 1, 2, 3, 4, 5 |
Primary outcome
Specific AE questions
Time frame: During 0-4 hours post dose
2 secondary outcomes
PK variables
Time frame: Frequent sampling up to 36 hours post dose
Safety variables (other adverse events, blood pressure, pulse, safety lab)
Time frame: During the whole treatment 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 3 Dec 2010.
Related trials for Gastroesophageal Reflux Disease
Recruiting
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
Mitral Regurgitation
RecruitingObservational study
Post-Marketing Surveillance to Evaluate the Safety and Effectiveness of Zastaprazan Citrate
Erosive Gastroesophageal Reflux Disease
Recruiting
Mesh Vs Pledgets for Repair of Paraesophageal Hernia
Paraesophageal Hernia, GERD
Not yet recruitingPhase 4
Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
Obese Adults
Recruiting
Phrenoesophageal Ligament Reconstruction With Mesh
Hiatus Hernia, Gastreoesophageal 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.
Eva Ersdal, PhD study director
AstraZeneca R&D, Mölndal, Sweden
Aslak Rautio, MD principal investigator
Quintiles Hermelinen, Varvsgatan 53, SE-972 33 Luleå, Sweden
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 AZD3355 in people with Gastroesophageal Reflux Disease, run by AstraZeneca at 1 site in Sweden.
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 3 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 Sweden. 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?
Specific AE questions (time frame: During 0-4 hours post dose). 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 3 Dec 2010.