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
연구 개요
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: First AZD1386, then washout, then placebo
|
95 mg, oral solution, single dose
Placebo, oral solution, single dose
|
|
실험적: First placebo, then washout, then AZD1386
|
95 mg, oral solution, single dose
Placebo, oral solution, single dose
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Time to Visual Analogue Scale 7 (VAS7) During Thermal Stimulation at 1.5 Hours Post-Dose.
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Time to Visual Analogue Scale 7 (VAS7) During Thermal Stimulation at 0.5 Hours Post Dose
기간: 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
기간: 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
기간: 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
기간: 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.
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 0 to 4 hours post dose
|
Maximum plasma concentration
|
0 to 4 hours post dose
|
|
Tmax
기간: 0 to 4 hours post dose
|
Time of maximum plasma concentration
|
0 to 4 hours post dose
|
|
SBP
기간: 1.5 hours post dose
|
Supine Systolic Blood Pressure at 1.5 hours post dose
|
1.5 hours post dose
|
|
DBP
기간: 1.5 hours post dose
|
Supine Diastolic Blood Pressure at 1.5 hours post dose
|
1.5 hours post dose
|
|
Pulse
기간: 1.5 hours post dose
|
Supine Pulse at 1.5 hours post dose
|
1.5 hours post dose
|
|
QTcF
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
스폰서
수사관
- 연구 책임자: Marie Sundin, AstraZeneca R&D, Mölndal, Sweden
- 수석 연구원: Peter Funch-Jensen,, MD, PhD, Aarhus Hospital, Dept of Surgical Gastroenterology, Aarhus, Denmark
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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