Sensitivity in Esophagus Clinical Trial
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.
| Status | Completed |
| Enrollment | 14 |
| Est. completion date | January 2011 |
| Est. primary completion date | January 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 70 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Research Site | Århus C | |
| Sweden | Research Site | Goteborg | Vastra Gotaland |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
Denmark, Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| 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: = 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 |
1.5 hours post dose | No |
| 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: = 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 |
0.5 hours post dose | No |
| 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: = 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 |
2.5 hours post dose | No |
| 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: = 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 |
0.5 hours post dose | No |
| 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: = 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 |
1.5 hours post dose | No |
| 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: = 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 |
2.5 hours post dose | No |
| 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: = 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 |
0.5 hours post dose | No |
| 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: = 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 |
1.5 hours post dose | No |
| 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: = 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 |
2.5 hours post dose | No |
| Secondary | AUCt | Area under the plasma concentration curve from time zero to the last quantifiable concentration | 0 to 4 hours post dose | No |
| Secondary | Cmax | Maximum plasma concentration | 0 to 4 hours post dose | No |
| Secondary | Tmax | Time of maximum plasma concentration | 0 to 4 hours post dose | No |
| Secondary | SBP | Supine Systolic Blood Pressure at 1.5 hours post dose | 1.5 hours post dose | Yes |
| Secondary | DBP | Supine Diastolic Blood Pressure at 1.5 hours post dose | 1.5 hours post dose | Yes |
| Secondary | Pulse | Supine Pulse at 1.5 hours post dose | 1.5 hours post dose | Yes |
| Secondary | QTcF | QT interval corrected for heart rate using Fredericia formula(QTcF) at 1.5 hours post dose | 1.5 hours post dose | Yes |
| Secondary | Body Temperature | Oral Body Temperature at 1.5 hours post dose | 1.5 hours post dose | Yes |
| Secondary | 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 | Yes |