PainPhase 1NCT00711048
Esophageal Hypersensitivity Study in Healthy Volunteers
A Phase 1 study testing AZD1386 in people with Pain and Esophageal Sensitivity, run by AstraZeneca at 2 sites in 2 countries.
Trial summary
The purpose of the study is to compare sensitivity and sensitization of visceral pain in the esophagus using different pain stimuli Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Esophageal Sensitivity
- What is being tested?
- AZD1386
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jun 2008to Jul 2009
- 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 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provision of written consent
- Clinically normal physical findings
- Sensitization potential
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
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Phase I, Two Centre, Double-blind, Randomized, Cross-over Study to Evaluate AZD1386 in Single Doses of 30 mg and 95 mg Compared to Placebo in a Multimodal Experimental Pain Model on Esophageal Sensitivity and Development of Sensitization in Healthy Male Volunteers
The purpose of the study is to compare sensitivity and sensitization of visceral pain in the esophagus using different pain stimuli
- Conditions
- Pain, Esophageal Sensitivity
- Being tested
- AZD1386, Placebo
- Keywords
- GERD, healthy volunteer, esophagus, pain
- Medical subject headings
- Pain, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD1386Drug
oral, single dose
PlaceboDrug
Oral solution, single dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 30 mg, oral, single dose Receives: Drug: AZD1386 |
| 2 | Experimental | 95 mg, oral, single dose Receives: Drug: AZD1386 |
| 3 | Placebo comparator | Oral solution, single dose Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS scale and clock
Measured: Several occasions during the study days
Secondary outcomes (3)
VAS scale and pressure, VAS scale and current, VAS scale and acid volume
Measured: Several occasions during the study days
Pharmacokinetic variables
Measured: Several occasions during the study days
Safety variables (adverse events, blood pressure, safety lab, ECG and body temperature)
Measured: Several occasions during the study days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2008 (estimated)
- Study startJun 2008
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Marie Sundin, Study director, AstraZeneca R&D, Mölndal, SwedenPeter Funch-Jensen, MD, PhD, Principal investigator, Aarhus University Hospital, Dept of Surgical Gastroenterology, Aarhus, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00711048
- Sponsor's protocol ID
- D9127C00001
- Other IDs
- 2008-000313-30, 2008
- Status last verified
- Aug 2009
- First submitted
- 7 Jul 2008
- Last updated
- 28 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Krarup AL, Ny L, Astrand M, Bajor A, Hvid-Jensen F, Hansen MB, Simren M, Funch-Jensen P, Drewes AM. Randomised clinical trial: the efficacy of a transient receptor potential vanilloid 1 antagonist AZD1386 in human oesophageal pain. Aliment Pharmacol Ther. 2011 May;33(10):1113-22. doi: 10.1111/j.1365-2036.2011.04629.x. Epub 2011 Mar 16.
PubMed 21410733
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Two Centre, Double-blind, Randomized, Cross-over Study to Evaluate AZD1386 in Single Doses of 30 mg and 95 mg Compared to Placebo in a Multimodal Experimental Pain Model on Esophageal Sensitivity and Development of Sensitization in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT00711048
- Acronym / sponsor ID
- D9127C00001
- Conditions
- Pain, Esophageal Sensitivity
- Keywords
- GERD, healthy volunteer, esophagus, pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Study completion
- Jul 2009 (actual)
- First posted
- 8 Jul 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 sensitivity and sensitization of visceral pain in the esophagus using different pain stimuli
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD138630 mg, oral, single dose |
| 2 | Experimental | Drug: AZD138695 mg, oral, single dose |
| 3 | Placebo comparator | Drug: PlaceboOral solution, single dose |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Provision of written consent
- Clinically normal physical findings
- Sensitization potential
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 |
|---|---|---|
| AZD1386oral, single dose | Drug | 1, 2 |
| PlaceboOral solution, single dose | Drug | 3 |
Primary outcome
VAS scale and clock
Time frame: Several occasions during the study days
3 secondary outcomes
VAS scale and pressure, VAS scale and current, VAS scale and acid volume
Time frame: Several occasions during the study days
Pharmacokinetic variables
Time frame: Several occasions during the study days
Safety variables (adverse events, blood pressure, safety lab, ECG and body temperature)
Time frame: Several occasions during the study days
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 28 Aug 2009.
- Derived from this study: PubMed 21410733Krarup AL, Ny L, Astrand M, Bajor A, Hvid-Jensen F, Hansen MB, Simren M, Funch-Jensen P, Drewes AM. Randomised clinical trial: the efficacy of a transient receptor potential vanilloid 1 antagonist AZD1386 in human oesophageal pain. Aliment Pharmacol Ther. 2011 May;33(10):1113-22. doi: 10.1111/j.1365-2036.2011.04629.x. Epub 2011 Mar 16.
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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.
Marie Sundin study director
AstraZeneca R&D, Mölndal, Sweden
Peter Funch-Jensen, MD, PhD principal investigator
Aarhus University Hospital, Dept of Surgical Gastroenterology, Aarhus, Denmark
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD1386 in people with Pain and Esophageal Sensitivity, run by AstraZeneca at 2 sites in 2 countries.
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 28 Aug 2009. 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 Denmark, 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. 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 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?
VAS scale and clock (time frame: Several occasions during the study days). 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 NCT00711048, which also lists 1 linked publication.
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 28 Aug 2009.