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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

The purpose of the study is to compare sensitivity of visceral pain in the esophagus using different pain stimuli.

Esophageal Hypersensitivity Study in patients with Gastroesophageal reflux disease (GERD)

Research Site

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

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

Age Continuous

Gender, Male/Female

Time to Visual Analogue Scale 7 (VAS7) during Thermal Stimulation at 1.5 Hours Post-Dose.

Time to Visual Analogue Scale 7 (VAS7) during thermal stimulation at 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).  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 0.5 hours post dose

Volume at Visual Analogue Scale 7 (VAS7) During Mechanical Stimulation at 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) 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 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

Current at Visual Analogue Scale 7 (VAS7) During Electrical Stimulation at 2.5 Hours Post Dose

Area under the plasma concentration curve from time zero to the last quantifiable concentration

AUCt

Cmax

tmax

Supine Systolic Blood Pressure at 1.5 hours post dose

Supine Diastolic Blood Pressure at 1.5 hours post dose

Pulse

QT interval corrected for heart rate using Fredericia formula(QTcF) at 1.5 hours post dose

QTcF

Oral Body Temperature at 1.5 hours post dose

Body Temperature

Number of participants with clinically relevant change of laboratory variables(clinical chemistry, haematology and urinalysis parameters)

Clinically relevant change of laboratory variables

Period 1

Period 2

Period 3

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.

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

Esophageal Hypersensitivity Study in patients with Gastroesophageal reflux disease (GERD)

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=432&filename=CSR-D9127C00002.pdf

CSR-D9127C00002.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator