Esophageal Hypersensitivity Study in Patients With Gastroesophageal Reflux Disease (GERD)
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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Contacts et emplacements
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: First AZD1386, then washout, then placebo
|
95 mg, oral solution, single dose
Placebo, oral solution, single dose
|
|
Expérimental: First placebo, then washout, then AZD1386
|
95 mg, oral solution, single dose
Placebo, oral solution, single dose
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Time to Visual Analogue Scale 7 (VAS7) During Thermal Stimulation at 1.5 Hours Post-Dose.
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Time to Visual Analogue Scale 7 (VAS7) During Thermal Stimulation at 0.5 Hours Post Dose
Délai: 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:
|
0.5 hours post dose
|
|
Time to Visual Analogue Scale 7 (VAS7) During Thermal Stimulation at 2.5 Hours Post Dose
Délai: 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
Délai: 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
Délai: 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.
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 0 to 4 hours post dose
|
Area under the plasma concentration curve from time zero to the last quantifiable concentration
|
0 to 4 hours post dose
|
|
Cmax
Délai: 0 to 4 hours post dose
|
Maximum plasma concentration
|
0 to 4 hours post dose
|
|
Tmax
Délai: 0 to 4 hours post dose
|
Time of maximum plasma concentration
|
0 to 4 hours post dose
|
|
SBP
Délai: 1.5 hours post dose
|
Supine Systolic Blood Pressure at 1.5 hours post dose
|
1.5 hours post dose
|
|
DBP
Délai: 1.5 hours post dose
|
Supine Diastolic Blood Pressure at 1.5 hours post dose
|
1.5 hours post dose
|
|
Pulse
Délai: 1.5 hours post dose
|
Supine Pulse at 1.5 hours post dose
|
1.5 hours post dose
|
|
QTcF
Délai: 1.5 hours post dose
|
QT interval corrected for heart rate using Fredericia formula(QTcF) at 1.5 hours post dose
|
1.5 hours post dose
|
|
Body Temperature
Délai: 1.5 hours post dose
|
Oral Body Temperature at 1.5 hours post dose
|
1.5 hours post dose
|
|
Clinically Relevant Change of Laboratory Variables
Délai: Pre-entry to follow-up
|
Number of participants with clinically relevant change of laboratory variables(clinical chemistry, haematology and urinalysis parameters)
|
Pre-entry to follow-up
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Marie Sundin, AstraZeneca R&D, Mölndal, Sweden
- Chercheur principal: Peter Funch-Jensen,, MD, PhD, Aarhus Hospital, Dept of Surgical Gastroenterology, Aarhus, Denmark
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- D9127C00002
- 2008-007420-26
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