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
調査の概要
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：First AZD1386, then washout, then placebo
|
95 mg, oral solution, single dose
Placebo, oral solution, single dose
|
|
実験的：First placebo, then washout, then AZD1386
|
95 mg, oral solution, single dose
Placebo, oral solution, single dose
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Time to Visual Analogue Scale 7 (VAS7) During Thermal Stimulation at 1.5 Hours Post-Dose.
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Time to Visual Analogue Scale 7 (VAS7) During Thermal Stimulation at 0.5 Hours Post Dose
時間枠：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
時間枠：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
|
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Volume at Visual Analogue Scale 7 (VAS7) During Mechanical Stimulation at 0.5 Hours Post Dose
時間枠：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
時間枠：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.
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
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Cmax
時間枠：0 to 4 hours post dose
|
Maximum plasma concentration
|
0 to 4 hours post dose
|
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Tmax
時間枠：0 to 4 hours post dose
|
Time of maximum plasma concentration
|
0 to 4 hours post dose
|
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SBP
時間枠：1.5 hours post dose
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Supine Systolic Blood Pressure at 1.5 hours post dose
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1.5 hours post dose
|
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DBP
時間枠：1.5 hours post dose
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Supine Diastolic Blood Pressure at 1.5 hours post dose
|
1.5 hours post dose
|
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Pulse
時間枠：1.5 hours post dose
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Supine Pulse at 1.5 hours post dose
|
1.5 hours post dose
|
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QTcF
時間枠：1.5 hours post dose
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QT interval corrected for heart rate using Fredericia formula(QTcF) at 1.5 hours post dose
|
1.5 hours post dose
|
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Body Temperature
時間枠：1.5 hours post dose
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Oral Body Temperature at 1.5 hours post dose
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1.5 hours post dose
|
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Clinically Relevant Change of Laboratory Variables
時間枠：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
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター：Marie Sundin、AstraZeneca R&D, Mölndal, Sweden
- 主任研究者：Peter Funch-Jensen,, MD, PhD、Aarhus Hospital, Dept of Surgical Gastroenterology, Aarhus, Denmark
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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