Esophageal Hypersensitivity Study in Patients With Gastroesophageal Reflux Disease (GERD)
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Purpose
The purpose of the study is to compare sensitivity of visceral pain in the esophagus using different pain stimuli.
| Condition | Intervention | Phase |
|---|---|---|
|
Sensitivity in Esophagus |
Drug: AZD1386 Drug: Placebo to AZD1386 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| 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 |
- Time to Visual Analogue Scale 7 (VAS7) During Thermal Stimulation at 1.5 Hours Post-Dose. [ Time Frame: 1.5 hours post dose ] [ Designated as safety issue: No ]
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
- Time to Visual Analogue Scale 7 (VAS7) During Thermal Stimulation at 0.5 Hours Post Dose [ Time Frame: 0.5 hours post dose ] [ Designated as safety issue: No ]
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
- Time to Visual Analogue Scale 7 (VAS7) During Thermal Stimulation at 2.5 Hours Post Dose [ Time Frame: 2.5 hours post dose ] [ Designated as safety issue: No ]
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
- Volume at Visual Analogue Scale 7 (VAS7) During Mechanical Stimulation at 0.5 Hours Post Dose [ Time Frame: 0.5 hours post dose ] [ Designated as safety issue: No ]
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
- Volume at Visual Analogue Scale 7 (VAS7) During Mechanical Stimulation at 1.5 Hours Post-Dose [ Time Frame: 1.5 hours post dose ] [ Designated as safety issue: No ]
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
- Volume at Visual Analogue Scale 7 (VAS7) During Mechanical Stimulation at 2.5 Hours Post-Dose. [ Time Frame: 2.5 hours post dose ] [ Designated as safety issue: No ]
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
- Current at Visual Analogue Scale 7 (VAS7) During Electrical Stimulation 0.5 Hours Post Dose [ Time Frame: 0.5 hours post dose ] [ Designated as safety issue: No ]
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
- Current at Visual Analogue Scale 7 (VAS7) During Electrical Stimulation at 1.5 Hours Post Dose [ Time Frame: 1.5 hours post dose ] [ Designated as safety issue: No ]
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
- Current at Visual Analogue Scale 7 (VAS7) During Electrical Stimulation at 2.5 Hours Post Dose [ Time Frame: 2.5 hours post dose ] [ Designated as safety issue: No ]
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
- AUCt [ Time Frame: 0 to 4 hours post dose ] [ Designated as safety issue: No ]Area under the plasma concentration curve from time zero to the last quantifiable concentration
- Cmax [ Time Frame: 0 to 4 hours post dose ] [ Designated as safety issue: No ]Maximum plasma concentration
- Tmax [ Time Frame: 0 to 4 hours post dose ] [ Designated as safety issue: No ]Time of maximum plasma concentration
- SBP [ Time Frame: 1.5 hours post dose ] [ Designated as safety issue: Yes ]Supine Systolic Blood Pressure at 1.5 hours post dose
- DBP [ Time Frame: 1.5 hours post dose ] [ Designated as safety issue: Yes ]Supine Diastolic Blood Pressure at 1.5 hours post dose
- Pulse [ Time Frame: 1.5 hours post dose ] [ Designated as safety issue: Yes ]Supine Pulse at 1.5 hours post dose
- QTcF [ Time Frame: 1.5 hours post dose ] [ Designated as safety issue: Yes ]QT interval corrected for heart rate using Fredericia formula(QTcF) at 1.5 hours post dose
- Body Temperature [ Time Frame: 1.5 hours post dose ] [ Designated as safety issue: Yes ]Oral Body Temperature at 1.5 hours post dose
- Clinically Relevant Change of Laboratory Variables [ Time Frame: Pre-entry to follow-up ] [ Designated as safety issue: Yes ]Number of participants with clinically relevant change of laboratory variables(clinical chemistry, haematology and urinalysis parameters)
| Enrollment: | 14 |
| Study Start Date: | November 2009 |
| Study Completion Date: | January 2011 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: First AZD1386, then washout, then placebo |
Drug: AZD1386
95 mg, oral solution, single dose
Drug: Placebo to AZD1386
Placebo, oral solution, single dose
|
| Experimental: First placebo, then washout, then AZD1386 |
Drug: AZD1386
95 mg, oral solution, single dose
Drug: Placebo to AZD1386
Placebo, oral solution, single dose
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations| Denmark | |
| Research Site | |
| Århus C, Denmark | |
| Sweden | |
| Research Site | |
| Goteborg, Vastra Gotaland, Sweden | |
| Study Director: | Marie Sundin | AstraZeneca R&D Mölndal, Sweden |
| Principal Investigator: | Peter Funch-Jensen,, MD, PhD | Aarhus Hospital, Dept of Surgical Gastroenterology, Aarhus, Denmark |
More Information
No publications provided
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT01019928 History of Changes |
| Other Study ID Numbers: | D9127C00002, 2008-007420-26 |
| Study First Received: | November 20, 2009 |
| Results First Received: | January 27, 2012 |
| Last Updated: | October 10, 2012 |
| Health Authority: | Denmark: Danish Medicines Agency Sweden: Medical Products Agency |
Keywords provided by AstraZeneca:
|
GERD patient esophagus pain |
Additional relevant MeSH terms:
|
Gastroesophageal Reflux Hypersensitivity Esophageal Motility Disorders Deglutition Disorders |
Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on May 21, 2013