Sensitivity in Esophagus
Conditions
Keywords
GERD, patient, esophagus, pain
Brief summary
The purpose of the study is to compare sensitivity of visceral pain in the esophagus using different pain stimuli.
Interventions
DRUGAZD1386
95 mg, oral solution, single dose
DRUGPlacebo to AZD1386
Placebo, oral solution, single dose
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Provision of signed informed consent form * BMI 18.5-35.0, inclusive * Continuous PPI treatment for GERD during the last 4 weeks
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Visual Analogue Scale 7 (VAS7) During Thermal Stimulation at 1.5 Hours Post-Dose. | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Visual Analogue Scale 7 (VAS7) During Thermal Stimulation at 2.5 Hours Post Dose | 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: 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 |
| Volume at Visual Analogue Scale 7 (VAS7) During Mechanical Stimulation at 0.5 Hours Post Dose | 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: 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 |
| Volume at Visual Analogue Scale 7 (VAS7) During Mechanical Stimulation at 1.5 Hours Post-Dose | 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: 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 |
| Volume at Visual Analogue Scale 7 (VAS7) During Mechanical Stimulation at 2.5 Hours Post-Dose. | 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: 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 |
| Current at Visual Analogue Scale 7 (VAS7) During Electrical Stimulation 0.5 Hours Post Dose | 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: 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 |
| Current at Visual Analogue Scale 7 (VAS7) During Electrical Stimulation at 1.5 Hours Post Dose | 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: 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 |
| Current at Visual Analogue Scale 7 (VAS7) During Electrical Stimulation at 2.5 Hours Post Dose | 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: 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 |
| AUCt | 0 to 4 hours post dose | Area under the plasma concentration curve from time zero to the last quantifiable concentration |
| Time to Visual Analogue Scale 7 (VAS7) During Thermal Stimulation at 0.5 Hours Post Dose | 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: 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 |
| Tmax | 0 to 4 hours post dose | Time of maximum plasma concentration |
| SBP | 1.5 hours post dose | Supine Systolic Blood Pressure at 1.5 hours post dose |
| DBP | 1.5 hours post dose | Supine Diastolic Blood Pressure at 1.5 hours post dose |
| Pulse | 1.5 hours post dose | Supine Pulse at 1.5 hours post dose |
| QTcF | 1.5 hours post dose | QT interval corrected for heart rate using Fredericia formula(QTcF) at 1.5 hours post dose |
| Body Temperature | 1.5 hours post dose | Oral Body Temperature at 1.5 hours post dose |
| Clinically Relevant Change of Laboratory Variables | Pre-entry to follow-up | Number of participants with clinically relevant change of laboratory variables(clinical chemistry, haematology and urinalysis parameters) |
| Cmax | 0 to 4 hours post dose | Maximum plasma concentration |
Countries
Denmark, Sweden
Participant flow
Recruitment details
A total of 30 patients were enrolled, 16 of these patients were NOT randomized for the following reasons: Voluntary discontinuation by patient = 3 Incorrect enrollment (did not meet inclusion/excl criteria) = 13
Pre-assignment details
14 patients were randomised, 1 patient received placebo in the first treatment period without any events, but had an SAE prior to receiving AZD1386 in the second period and was withdrawn. 13 randomised patients completed the study, but one of these patients was incorrectly enrolled and excluded from the per-protocol analysis set.
Participants by arm
| Arm | Count |
|---|---|
| AZD1386 95 mg | 7 |
| Placebo | 7 |
| Total | 14 |
Baseline characteristics
| Characteristic | AZD1386 95 mg | Placebo | Total |
|---|---|---|---|
| Age Continuous Age (years) | 54.9 years STANDARD_DEVIATION 15 | 54.7 years STANDARD_DEVIATION 17.4 | 54.8 years STANDARD_DEVIATION 16.2 |
| Sex: Female, Male Female | 5 Participants | 4 Participants | 9 Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 11 / 13 | 2 / 14 |
| serious Total, serious adverse events | 0 / 13 | 1 / 14 |
Outcome results
Primary
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: 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
Time frame: 1.5 hours post dose
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD1386 95 mg | Time to Visual Analogue Scale 7 (VAS7) During Thermal Stimulation at 1.5 Hours Post-Dose. | 84.0 seconds |
| Placebo | Time to Visual Analogue Scale 7 (VAS7) During Thermal Stimulation at 1.5 Hours Post-Dose. | 86.9 seconds |
Secondary
AUCt
Area under the plasma concentration curve from time zero to the last quantifiable concentration
Time frame: 0 to 4 hours post dose
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD1386 95 mg | AUCt | 5899 nmol*h/L |
Secondary
Body Temperature
Oral Body Temperature at 1.5 hours post dose
Time frame: 1.5 hours post dose
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD1386 95 mg | Body Temperature | 37.2 degrees Celsius | Standard Deviation 0.4 |
| Placebo | Body Temperature | 36.8 degrees Celsius | Standard Deviation 0.3 |
Secondary
Clinically Relevant Change of Laboratory Variables
Number of participants with clinically relevant change of laboratory variables(clinical chemistry, haematology and urinalysis parameters)
Time frame: Pre-entry to follow-up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AZD1386 95 mg | Clinically Relevant Change of Laboratory Variables | 0 Participants |
| Placebo | Clinically Relevant Change of Laboratory Variables | 0 Participants |
Secondary
Cmax
Maximum plasma concentration
Time frame: 0 to 4 hours post dose
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD1386 95 mg | Cmax | 2361 nmol/L |
Secondary
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: 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
Time frame: 0.5 hours post dose
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD1386 95 mg | Current at Visual Analogue Scale 7 (VAS7) During Electrical Stimulation 0.5 Hours Post Dose | 16.7 mA |
| Placebo | Current at Visual Analogue Scale 7 (VAS7) During Electrical Stimulation 0.5 Hours Post Dose | 16.7 mA |
Secondary
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: 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
Time frame: 1.5 hours post dose
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD1386 95 mg | Current at Visual Analogue Scale 7 (VAS7) During Electrical Stimulation at 1.5 Hours Post Dose | 16.7 mA |
| Placebo | Current at Visual Analogue Scale 7 (VAS7) During Electrical Stimulation at 1.5 Hours Post Dose | 15.8 mA |
Secondary
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: 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
Time frame: 2.5 hours post dose
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD1386 95 mg | Current at Visual Analogue Scale 7 (VAS7) During Electrical Stimulation at 2.5 Hours Post Dose | 16.2 mA |
| Placebo | Current at Visual Analogue Scale 7 (VAS7) During Electrical Stimulation at 2.5 Hours Post Dose | 14.8 mA |
Secondary
DBP
Supine Diastolic Blood Pressure at 1.5 hours post dose
Time frame: 1.5 hours post dose
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD1386 95 mg | DBP | 81.4 mmHg | Standard Deviation 8.1 |
| Placebo | DBP | 80.0 mmHg | Standard Deviation 7.3 |
Secondary
Pulse
Supine Pulse at 1.5 hours post dose
Time frame: 1.5 hours post dose
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD1386 95 mg | Pulse | 67.8 beats/min | Standard Deviation 12.9 |
| Placebo | Pulse | 62.2 beats/min | Standard Deviation 9.4 |
Secondary
QTcF
QT interval corrected for heart rate using Fredericia formula(QTcF) at 1.5 hours post dose
Time frame: 1.5 hours post dose
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD1386 95 mg | QTcF | 409.6 ms | Standard Deviation 19 |
| Placebo | QTcF | 414.3 ms | Standard Deviation 17.3 |
Secondary
SBP
Supine Systolic Blood Pressure at 1.5 hours post dose
Time frame: 1.5 hours post dose
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD1386 95 mg | SBP | 145.8 mmHg | Standard Deviation 10.3 |
| Placebo | SBP | 139.7 mmHg | Standard Deviation 12.7 |
Secondary
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: 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
Time frame: 0.5 hours post dose
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD1386 95 mg | Time to Visual Analogue Scale 7 (VAS7) During Thermal Stimulation at 0.5 Hours Post Dose | 86.0 seconds |
| Placebo | Time to Visual Analogue Scale 7 (VAS7) During Thermal Stimulation at 0.5 Hours Post Dose | 87.8 seconds |
Secondary
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: 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
Time frame: 2.5 hours post dose
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD1386 95 mg | Time to Visual Analogue Scale 7 (VAS7) During Thermal Stimulation at 2.5 Hours Post Dose | 85.5 seconds |
| Placebo | Time to Visual Analogue Scale 7 (VAS7) During Thermal Stimulation at 2.5 Hours Post Dose | 77.0 seconds |
Secondary
Tmax
Time of maximum plasma concentration
Time frame: 0 to 4 hours post dose
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| AZD1386 95 mg | Tmax | 1.0 hours |
Secondary
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: 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
Time frame: 0.5 hours post dose
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD1386 95 mg | Volume at Visual Analogue Scale 7 (VAS7) During Mechanical Stimulation at 0.5 Hours Post Dose | 16.2 ml |
| Placebo | Volume at Visual Analogue Scale 7 (VAS7) During Mechanical Stimulation at 0.5 Hours Post Dose | 15.1 ml |
Secondary
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: 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
Time frame: 1.5 hours post dose
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD1386 95 mg | Volume at Visual Analogue Scale 7 (VAS7) During Mechanical Stimulation at 1.5 Hours Post-Dose | 15.0 ml |
| Placebo | Volume at Visual Analogue Scale 7 (VAS7) During Mechanical Stimulation at 1.5 Hours Post-Dose | 16.7 ml |
Secondary
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: 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
Time frame: 2.5 hours post dose
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| AZD1386 95 mg | Volume at Visual Analogue Scale 7 (VAS7) During Mechanical Stimulation at 2.5 Hours Post-Dose. | 15.4 ml |
| Placebo | Volume at Visual Analogue Scale 7 (VAS7) During Mechanical Stimulation at 2.5 Hours Post-Dose. | 15.2 ml |