Sensitivity in EsophagusPhase 2NCT01019928
Esophageal Hypersensitivity Study in Patients With Gastroesophageal Reflux Disease (GERD)
A Phase 2 study testing AZD1386 in people with Sensitivity in Esophagus, run by AstraZeneca at 2 sites in 2 countries.
Trial summary
The purpose of the study is to compare sensitivity of visceral pain in the esophagus using different pain stimuli. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Sensitivity in Esophagus
- 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
- 14 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Nov 2009to Jan 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed informed consent form
- BMI 18.5-35.0, inclusive
- Continuous PPI treatment for GERD during the last 4 weeks
Who cannot join
- Patients that have not experienced any GERD symptoms improvement at all after PPI treatment
- Unstable or clinically significant disorders including cardiovascular, respiratory, renal, hepatic, metabolic, psychiatric, other gastrointestinal and esophageal disorders besides GERD
- Prior surgery of the upper GI tract
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Phase IIa, Double-blind, Randomized, 2-way Cross-over Study to Evaluate the Effect of a Single Dose of AZD1386 95 mg Compared to Placebo in a Multimodal Experimental Pain Model on Esophageal Sensitivity in GERD Patients With a Partial Response to PPI Treatment
The purpose of the study is to compare sensitivity of visceral pain in the esophagus using different pain stimuli.
- Conditions
- Sensitivity in Esophagus
- Being tested
- AZD1386, Placebo to AZD1386
- Keywords
- GERD, patient, esophagus, pain
- Medical subject headings
- Gastroesophageal Reflux, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD1386Drug
95 mg, oral solution, single dose
Placebo to AZD1386Drug
Placebo, oral solution, single dose
| Study group | Role | What they receive |
|---|---|---|
| First AZD1386, then washout, then placebo | Experimental | Not described Receives: Drug: AZD1386; Drug: Placebo to AZD1386 |
| First placebo, then washout, then AZD1386 | Experimental | Not described Receives: Drug: AZD1386; Drug: Placebo to AZD1386 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Visual Analogue Scale 7 (VAS7) During Thermal Stimulation at 1.5 Hours Post-Dose.
A probe (bag) was inserted 7cm above the lower esophageal sphincter (LES). Heat stimuli were applied by recirculation of heated water in the bag. Prior to recirculation the bag is filled with 7mL to ensure adequate mucosal contact. Water was heated up to a maximum of 63° C and the stimulation was continued until VAS 7 was reached.
The intensities of the non-painful sensations were scored with the following descriptors added to facilitate the scoring:
- = vague perception of mild sensation
- = definite perception of mild sensation
- = vague perception of moderate sensation
- = definite perception of moderate sensation For painful sensations the patients will use the scale from 5-10 anchored at:
- = pain detection
- = slight pain
- = moderate pain
- = medium pain intensity
- = intense pain
- = unbearable pain
Measured: 1.5 hours post dose
Secondary outcomes (17)
Time to Visual Analogue Scale 7 (VAS7) During Thermal Stimulation at 0.5 Hours Post Dose
A probe (bag) was inserted 7cm above the lower esophageal sphincter (LES). Heat stimuli were applied by recirculation of heated water in the bag. Prior to recirculation the bag is filled with 7mL to ensure adequate mucosal contact. Water was heated up to a maximum of 63° C and the stimulation was continued until VAS 7 was reached.
The intensities of the non-painful sensations were scored with the following descriptors added to facilitate the scoring:
- = vague perception of mild sensation
- = definite perception of mild sensation
- = vague perception of moderate sensation
- = definite perception of moderate sensation For painful sensations the patients will use the scale from 5-10 anchored at:
- = pain detection
- = slight pain
- = moderate pain
- = medium pain intensity
- = intense pain
- = unbearable pain
Measured: 0.5 hours post dose
Time to Visual Analogue Scale 7 (VAS7) During Thermal Stimulation at 2.5 Hours Post Dose
A probe (bag) was inserted 7cm above the lower esophageal sphincter (LES). Heat stimuli were applied by recirculation of heated water in the bag. Prior to recirculation the bag is filled with 7mL to ensure adequate mucosal contact. Water was heated up to a maximum of 63° C and the stimulation was continued until VAS 7 was reached.
The intensities of the non-painful sensations were scored with the following descriptors added to facilitate the scoring:
- = vague perception of mild sensation
- = definite perception of mild sensation
- = vague perception of moderate sensation
- = definite perception of moderate sensation For painful sensations the patients will use the scale from 5-10 anchored at:
- = pain detection
- = slight pain
- = moderate pain
- = medium pain intensity
- = intense pain
- = unbearable pain
Measured: 2.5 hours post dose
Volume at Visual Analogue Scale 7 (VAS7) During Mechanical Stimulation at 0.5 Hours Post Dose
A probe (bag) was inserted 7cm above the lower esophageal sphincter (LES). Volume change in the bag was recorded continuously at each level of the visual analogue scale (VAS) and up to VAS7 (Volume at Visual Analogue Scale 7).
The intensities of the non-painful sensations were scored with the following descriptors added to facilitate the scoring:
- = vague perception of mild sensation
- = definite perception of mild sensation
- = vague perception of moderate sensation
- = definite perception of moderate sensation For painful sensations the patients will use the scale from 5-10 anchored at:
- = pain detection
- = slight pain
- = moderate pain
- = medium pain intensity
- = intense pain
- = unbearable pain
Measured: 0.5 hours post dose
Volume at Visual Analogue Scale 7 (VAS7) During Mechanical Stimulation at 1.5 Hours Post-Dose
A probe (bag) was inserted 7cm above the lower esophageal sphincter (LES). Volume change in the bag was recorded continuously at each level of the visual analogue scale (VAS) and up to VAS7 (Volume at Visual Analogue Scale 7).
The intensities of the non-painful sensations were scored with the following descriptors added to facilitate the scoring:
- = vague perception of mild sensation
- = definite perception of mild sensation
- = vague perception of moderate sensation
- = definite perception of moderate sensation For painful sensations the patients will use the scale from 5-10 anchored at:
- = pain detection
- = slight pain
- = moderate pain
- = medium pain intensity
- = intense pain
- = unbearable pain
Measured: 1.5 hours post dose
Volume at Visual Analogue Scale 7 (VAS7) During Mechanical Stimulation at 2.5 Hours Post-Dose.
A probe (bag) was inserted 7cm above the lower esophageal sphincter (LES). Volume change in the bag was recorded continuously at each level of the visual analogue scale (VAS) and up to VAS7 (Volume at Visual Analogue Scale 7).
The intensities of the non-painful sensations were scored with the following descriptors added to facilitate the scoring:
- = vague perception of mild sensation
- = definite perception of mild sensation
- = vague perception of moderate sensation
- = definite perception of moderate sensation For painful sensations the patients will use the scale from 5-10 anchored at:
- = pain detection
- = slight pain
- = moderate pain
- = medium pain intensity
- = intense pain
- = unbearable pain
Measured: 2.5 hours post dose
Current at Visual Analogue Scale 7 (VAS7) During Electrical Stimulation 0.5 Hours Post Dose
A probe (bag) was inserted 7cm above the lower esophageal sphincter (LES) and stimulations were performed at approximately 8 cm above the LES. The intensity of the stimuli is increased steadily in steps of 0.5 to 1 mA and the intensity corresponding to the VAS levels 1, 3, 5 and 7 were recorded.
The current will be increased until the patient report moderate pain (VAS 7) or max 80 mA.
The intensities of the non-painful sensations were scored with the following descriptors added to facilitate the scoring:
- = vague perception of mild sensation
- = definite perception of mild sensation
- = vague perception of moderate sensation
- = definite perception of moderate sensation For painful sensations the patients will use the scale from 5-10 anchored at:
- = pain detection
- = slight pain
- = moderate pain
- = medium pain intensity
- = intense pain
- = unbearable pain
Measured: 0.5 hours post dose
Current at Visual Analogue Scale 7 (VAS7) During Electrical Stimulation at 1.5 Hours Post Dose
A probe (bag) was inserted 7cm above the lower esophageal sphincter (LES) and stimulations were performed at approximately 8 cm above the LES. The intensity of the stimuli is increased steadily in steps of 0.5 to 1 mA and the intensity corresponding to the VAS levels 1, 3, 5 and 7 were recorded.
The current will be increased until the patient report moderate pain (VAS 7) or max 80 mA.
The intensities of the non-painful sensations were scored with the following descriptors added to facilitate the scoring:
- = vague perception of mild sensation
- = definite perception of mild sensation
- = vague perception of moderate sensation
- = definite perception of moderate sensation For painful sensations the patients will use the scale from 5-10 anchored at:
- = pain detection
- = slight pain
- = moderate pain
- = medium pain intensity
- = intense pain
- = unbearable pain
Measured: 1.5 hours post dose
Current at Visual Analogue Scale 7 (VAS7) During Electrical Stimulation at 2.5 Hours Post Dose
A probe (bag) was inserted 7cm above the lower esophageal sphincter (LES) and stimulations were performed at approximately 8 cm above the LES. The intensity of the stimuli is increased steadily in steps of 0.5 to 1 mA and the intensity corresponding to the VAS levels 1, 3, 5 and 7 were recorded.
The current will be increased until the patient report moderate pain (VAS 7) or max 80 mA.
The intensities of the non-painful sensations were scored with the following descriptors added to facilitate the scoring:
- = vague perception of mild sensation
- = definite perception of mild sensation
- = vague perception of moderate sensation
- = definite perception of moderate sensation For painful sensations the patients will use the scale from 5-10 anchored at:
- = pain detection
- = slight pain
- = moderate pain
- = medium pain intensity
- = intense pain
- = unbearable pain
Measured: 2.5 hours post dose
AUCt
Area under the plasma concentration curve from time zero to the last quantifiable concentration
Measured: 0 to 4 hours post dose
Cmax
Maximum plasma concentration
Measured: 0 to 4 hours post dose
Tmax
Time of maximum plasma concentration
Measured: 0 to 4 hours post dose
SBP
Supine Systolic Blood Pressure at 1.5 hours post dose
Measured: 1.5 hours post dose
DBP
Supine Diastolic Blood Pressure at 1.5 hours post dose
Measured: 1.5 hours post dose
Pulse
Supine Pulse at 1.5 hours post dose
Measured: 1.5 hours post dose
QTcF
QT interval corrected for heart rate using Fredericia formula(QTcF) at 1.5 hours post dose
Measured: 1.5 hours post dose
Body Temperature
Oral Body Temperature at 1.5 hours post dose
Measured: 1.5 hours post dose
Clinically Relevant Change of Laboratory Variables
Number of participants with clinically relevant change of laboratory variables(clinical chemistry, haematology and urinalysis parameters)
Measured: Pre-entry to follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sensitivity in EsophagusStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marie Sundin, Study director, AstraZeneca R&D, Mölndal, SwedenPeter Funch-Jensen,, MD, PhD, Principal investigator, Aarhus Hospital, Dept of Surgical Gastroenterology, Aarhus, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01019928
- Sponsor's protocol ID
- D9127C00002
- Other IDs
- 2008-007420-26, 2008
- Status last verified
- Oct 2012
- First submitted
- 20 Nov 2009
- Last updated
- 9 Nov 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Krarup AL, Ny L, Gunnarsson J, Hvid-Jensen F, Zetterstrand S, Simren M, Funch-Jensen P, Hansen MB, Drewes AM. Randomized clinical trial: inhibition of the TRPV1 system in patients with nonerosive gastroesophageal reflux disease and a partial response to PPI treatment is not associated with analgesia to esophageal experimental pain. Scand J Gastroenterol. 2013 Mar;48(3):274-84. doi: 10.3109/00365521.2012.758769. Epub 2013 Jan 16.
PubMed 23320520
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa, Double-blind, Randomized, 2-way Cross-over Study to Evaluate the Effect of a Single Dose of AZD1386 95 mg Compared to Placebo in a Multimodal Experimental Pain Model on Esophageal Sensitivity in GERD Patients With a Partial Response to PPI Treatment
- ClinicalTrials.gov ID
- NCT01019928
- Acronym / sponsor ID
- D9127C00002
- Conditions
- Sensitivity in Esophagus
- Keywords
- GERD, patient, esophagus, pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 25 Nov 2009 (estimated)
- Results
- Posted 9 Nov 2012
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 of visceral pain in the esophagus using different pain stimuli.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First AZD1386, then washout, then placebo | Experimental | Drug: AZD1386, Drug: Placebo to AZD1386 |
| First placebo, then washout, then AZD1386 | Experimental | Drug: AZD1386, Drug: Placebo to AZD1386 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Provision of signed informed consent form
- BMI 18.5-35.0, inclusive
- Continuous PPI treatment for GERD during the last 4 weeks
Key exclusion criteria (3 listed)
- Patients that have not experienced any GERD symptoms improvement at all after PPI treatment
- Unstable or clinically significant disorders including cardiovascular, respiratory, renal, hepatic, metabolic, psychiatric, other gastrointestinal and esophageal disorders besides GERD
- Prior surgery of the upper GI tract
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 |
|---|---|---|
| AZD138695 mg, oral solution, single dose | Drug | First AZD1386, then washout, then placebo, First placebo, then washout, then AZD1386 |
| Placebo to AZD1386Placebo, oral solution, single dose | Drug | First AZD1386, then washout, then placebo, First placebo, then washout, then AZD1386 |
Primary outcome
Time to Visual Analogue Scale 7 (VAS7) During Thermal Stimulation at 1.5 Hours Post-Dose.
Time frame: 1.5 hours post dose
A probe (bag) was inserted 7cm above the lower esophageal sphincter (LES). Heat stimuli were applied by recirculation of heated water in the bag. Prior to recirculation the bag is filled with 7mL to ensure adequate mucosal contact. Water was heated up to a maximum of 63° C and the stimulation was continued until VAS 7 was reached. The intensities of the non-painful sensations were scored with the following descriptors added to facilitate the scoring: 1. = vague perception of mild sensation 2. = definite perception of mild sensation 3. = vague perception of moderate sensation 4. = definite perception of moderate sensation For painful sensations the patients will use the scale from 5-10 anchored at: 5. = pain detection 6. = slight pain 7. = moderate pain 8. = medium pain intensity 9. = intense pain 10. = unbearable pain
17 secondary outcomes
Time to Visual Analogue Scale 7 (VAS7) During Thermal Stimulation at 0.5 Hours Post Dose
Time frame: 0.5 hours post dose
Time to Visual Analogue Scale 7 (VAS7) During Thermal Stimulation at 2.5 Hours Post Dose
Time frame: 2.5 hours post dose
Volume at Visual Analogue Scale 7 (VAS7) During Mechanical Stimulation at 0.5 Hours Post Dose
Time frame: 0.5 hours post dose
Volume at Visual Analogue Scale 7 (VAS7) During Mechanical Stimulation at 1.5 Hours Post-Dose
Time frame: 1.5 hours post dose
Volume at Visual Analogue Scale 7 (VAS7) During Mechanical Stimulation at 2.5 Hours Post-Dose.
Time frame: 2.5 hours post dose
Current at Visual Analogue Scale 7 (VAS7) During Electrical Stimulation 0.5 Hours Post Dose
Time frame: 0.5 hours post dose
Current at Visual Analogue Scale 7 (VAS7) During Electrical Stimulation at 1.5 Hours Post Dose
Time frame: 1.5 hours post dose
Current at Visual Analogue Scale 7 (VAS7) During Electrical Stimulation at 2.5 Hours Post Dose
Time frame: 2.5 hours post dose
AUCt
Time frame: 0 to 4 hours post dose
Cmax
Time frame: 0 to 4 hours post dose
Tmax
Time frame: 0 to 4 hours post dose
SBP
Time frame: 1.5 hours post dose
DBP
Time frame: 1.5 hours post dose
Pulse
Time frame: 1.5 hours post dose
QTcF
Time frame: 1.5 hours post dose
Body Temperature
Time frame: 1.5 hours post dose
Clinically Relevant Change of Laboratory Variables
Time frame: Pre-entry to follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23320520Krarup AL, Ny L, Gunnarsson J, Hvid-Jensen F, Zetterstrand S, Simren M, Funch-Jensen P, Hansen MB, Drewes AM. Randomized clinical trial: inhibition of the TRPV1 system in patients with nonerosive gastroesophageal reflux disease and a partial response to PPI treatment is not associated with analgesia to esophageal experimental pain. Scand J Gastroenterol. 2013 Mar;48(3):274-84. doi: 10.3109/00365521.2012.758769. Epub 2013 Jan 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 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 2 study testing AZD1386 in people with Sensitivity in Esophagus, 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 9 Nov 2012. 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. 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 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?
Yes. Results are posted in the registry (first posted 9 Nov 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Time to Visual Analogue Scale 7 (VAS7) During Thermal Stimulation at 1.5 Hours Post-Dose. (time frame: 1.5 hours post dose). 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 NCT01019928, 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 9 Nov 2012.