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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-007420-26 |
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The purpose of the study is to compare sensitivity of visceral pain in the esophagus using different pain stimuli.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| First AZD1386, then washout, then placebo | Experimental |
| |
| First placebo, then washout, then AZD1386 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD1386 | Drug | 95 mg, oral solution, single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 1.5 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marie Sundin | AstraZeneca R&D, Mölndal, Sweden | Study Director |
| Peter Funch-Jensen,, MD, PhD | Aarhus Hospital, Dept of Surgical Gastroenterology, Aarhus, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Ã…rhus C | Denmark | ||||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23320520 | Derived | 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. |
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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.
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
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| ID | Title | Description |
|---|---|---|
| FG000 | First AZD1386, Then Washout, Then Placebo | |
| FG001 | First Placebo, Then Washout, Then AZD1386 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
| |||||||||||||
| Period 2 |
| |||||||||||||
| Period 3 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AZD1386 95 mg | |
| BG001 | Placebo | |
| BG002 | Total |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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:
| Posted | Geometric Mean | Full Range | seconds | 1.5 hours post dose |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AZD1386 95 mg |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ECG, atrial fibrillation | Cardiac disorders | MedDRA 10.0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Feeling Cold | General disorders | MedDRA 10.0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | +44 1625 518062 | aztrial_results_posting@astrazeneca.com |
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| D010146 | Pain |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| C574562 | AZD1386 |
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| Placebo to AZD1386 | Drug | Placebo, oral solution, single dose |
|
| 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:
| 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:
| 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:
| 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:
| 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:
| 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:
| 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:
| 2.5 hours post dose |
| AUCt | Area under the plasma concentration curve from time zero to the last quantifiable concentration | 0 to 4 hours post dose |
| Cmax | Maximum plasma concentration | 0 to 4 hours post dose |
| Tmax | Time of maximum plasma concentration | 0 to 4 hours post dose |
| SBP | Supine Systolic Blood Pressure at 1.5 hours post dose | 1.5 hours post dose |
| DBP | Supine Diastolic Blood Pressure at 1.5 hours post dose | 1.5 hours post dose |
| Pulse | Supine Pulse at 1.5 hours post dose | 1.5 hours post dose |
| QTcF | QT interval corrected for heart rate using Fredericia formula(QTcF) at 1.5 hours post dose | 1.5 hours post dose |
| Body Temperature | Oral Body Temperature at 1.5 hours post dose | 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) | Pre-entry to follow-up |
| Gothenburg |
| Västra Götaland County |
| Sweden |
| NOT COMPLETED |
|
| NOT COMPLETED |
|
Total of all reporting groups
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Placebo |
|
|
| 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:
| Posted | Geometric Mean | Full Range | seconds | 0.5 hours post dose |
|
|
|
| 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:
| Posted | Geometric Mean | Full Range | seconds | 2.5 hours post dose |
|
|
|
| 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:
| Posted | Geometric Mean | Full Range | ml | 0.5 hours post dose |
|
|
|
| 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:
| Posted | Geometric Mean | Full Range | ml | 1.5 hours post dose |
|
|
|
| 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:
| Posted | Geometric Mean | Full Range | ml | 2.5 hours post dose |
|
|
|
| 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:
| Posted | Geometric Mean | Full Range | mA | 0.5 hours post dose |
|
|
|
| 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:
| Posted | Geometric Mean | Full Range | mA | 1.5 hours post dose |
|
|
|
| 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:
| Posted | Geometric Mean | Full Range | mA | 2.5 hours post dose |
|
|
|
| Secondary | AUCt | Area under the plasma concentration curve from time zero to the last quantifiable concentration | Posted | Geometric Mean | 95% Confidence Interval | nmol*h/L | 0 to 4 hours post dose |
|
|
|
| Secondary | Cmax | Maximum plasma concentration | Posted | Geometric Mean | 95% Confidence Interval | nmol/L | 0 to 4 hours post dose |
|
|
|
| Secondary | Tmax | Time of maximum plasma concentration | Posted | Median | Full Range | hours | 0 to 4 hours post dose |
|
|
|
| Secondary | SBP | Supine Systolic Blood Pressure at 1.5 hours post dose | Posted | Mean | Standard Deviation | mmHg | 1.5 hours post dose |
|
|
|
| Secondary | DBP | Supine Diastolic Blood Pressure at 1.5 hours post dose | Posted | Mean | Standard Deviation | mmHg | 1.5 hours post dose |
|
|
|
| Secondary | Pulse | Supine Pulse at 1.5 hours post dose | Posted | Mean | Standard Deviation | beats/min | 1.5 hours post dose |
|
|
|
| Secondary | QTcF | QT interval corrected for heart rate using Fredericia formula(QTcF) at 1.5 hours post dose | Posted | Mean | Standard Deviation | ms | 1.5 hours post dose |
|
|
|
| Secondary | Body Temperature | Oral Body Temperature at 1.5 hours post dose | Posted | Mean | Standard Deviation | degrees Celsius | 1.5 hours post dose |
|
|
|
| Secondary | Clinically Relevant Change of Laboratory Variables | Number of participants with clinically relevant change of laboratory variables(clinical chemistry, haematology and urinalysis parameters) | Posted | Number | Participants | Pre-entry to follow-up |
|
|
|
| 0 |
| 13 |
| 11 |
| 13 |
| EG001 | Placebo | 1 | 14 | 2 | 14 |
| Chills | General disorders | MedDRA 10.0 |
|
| Feeling Of Body Temperature Change | General disorders | MedDRA 10.0 |
|
| Pain | General disorders | MedDRA 10.0 |
|
| Hypoaesthesia Oral | General disorders | MedDRA 10.0 |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 10.0 |
|
| Nausea | Gastrointestinal disorders | MedDRA 10.0 |
|
| Oesophageal Disorder | Gastrointestinal disorders | MedDRA 10.0 |
|
| Vomiting | Gastrointestinal disorders | MedDRA 10.0 |
|
| Body Temperature Increased | Investigations | MedDRA 10.0 |
|
| Ageusia | Nervous system disorders | MedDRA 10.0 |
|
| Burning Sensation | Nervous system disorders | MedDRA 10.0 |
|
| Dysgeusia | Nervous system disorders | MedDRA 10.0 |
|
| Headache | Nervous system disorders | MedDRA 10.0 |
|
| Paraesthesia | Nervous system disorders | MedDRA 10.0 |
|
| Throat Irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 |
|
| Arthropod Sting | Injury, poisoning and procedural complications | MedDRA 10.0 |
|
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 |
|
| Peripheral Coldness | General disorders | MedDRA 10.0 |
|
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| D004066 | Digestive System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |