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Esophageal Hypersensitivity Study in Patients With Gastroesophageal Reflux Disease (GERD)

10. října 2012 aktualizováno: AstraZeneca

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

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

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

14

Fáze

  • Fáze 2

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Dánsko
      • Århus C, Dánsko
        • Research Site
  • Švédsko
    • Vastra Gotaland
      • Goteborg, Vastra Gotaland, Švédsko
        • Research Site

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 70 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Crossover Assignment
  • Maskování: Trojnásobný

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: First AZD1386, then washout, then placebo
Lék: AZD1386
95 mg, oral solution, single dose
Lék: Placebo to AZD1386
Placebo, oral solution, single dose
Experimentální: First placebo, then washout, then AZD1386
Lék: AZD1386
95 mg, oral solution, single dose
Lék: Placebo to AZD1386
Placebo, oral solution, single dose

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Time to Visual Analogue Scale 7 (VAS7) During Thermal Stimulation at 1.5 Hours Post-Dose.
Časové okno: 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. = 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
1.5 hours post dose

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Time to Visual Analogue Scale 7 (VAS7) During Thermal Stimulation at 0.5 Hours Post Dose
Časové okno: 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:

  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
0.5 hours post dose
Time to Visual Analogue Scale 7 (VAS7) During Thermal Stimulation at 2.5 Hours Post Dose
Časové okno: 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:

  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
2.5 hours post dose
Volume at Visual Analogue Scale 7 (VAS7) During Mechanical Stimulation at 0.5 Hours Post Dose
Časové okno: 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:

  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
0.5 hours post dose
Volume at Visual Analogue Scale 7 (VAS7) During Mechanical Stimulation at 1.5 Hours Post-Dose
Časové okno: 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. = 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
1.5 hours post dose
Volume at Visual Analogue Scale 7 (VAS7) During Mechanical Stimulation at 2.5 Hours Post-Dose.
Časové okno: 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
2.5 hours post dose
Current at Visual Analogue Scale 7 (VAS7) During Electrical Stimulation 0.5 Hours Post Dose
Časové okno: 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
0.5 hours post dose
Current at Visual Analogue Scale 7 (VAS7) During Electrical Stimulation at 1.5 Hours Post Dose
Časové okno: 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. = 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
1.5 hours post dose
Current at Visual Analogue Scale 7 (VAS7) During Electrical Stimulation at 2.5 Hours Post Dose
Časové okno: 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
2.5 hours post dose
AUCt
Časové okno: 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
Časové okno: 0 to 4 hours post dose
Maximum plasma concentration
0 to 4 hours post dose
Tmax
Časové okno: 0 to 4 hours post dose
Time of maximum plasma concentration
0 to 4 hours post dose
SBP
Časové okno: 1.5 hours post dose
Supine Systolic Blood Pressure at 1.5 hours post dose
1.5 hours post dose
DBP
Časové okno: 1.5 hours post dose
Supine Diastolic Blood Pressure at 1.5 hours post dose
1.5 hours post dose
Pulse
Časové okno: 1.5 hours post dose
Supine Pulse at 1.5 hours post dose
1.5 hours post dose
QTcF
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

AstraZeneca

Vyšetřovatelé

  • Ředitel studie: Marie Sundin, AstraZeneca R&D, Mölndal, Sweden
  • Vrchní vyšetřovatel: Peter Funch-Jensen,, MD, PhD, Aarhus Hospital, Dept of Surgical Gastroenterology, Aarhus, Denmark

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. listopadu 2009

Primární dokončení (Aktuální)

1. ledna 2011

Dokončení studie (Aktuální)

1. ledna 2011

Termíny zápisu do studia

První předloženo

20. listopadu 2009

První předloženo, které splnilo kritéria kontroly kvality

24. listopadu 2009

První zveřejněno (Odhad)

25. listopadu 2009

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

9. listopadu 2012

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

10. října 2012

Naposledy ověřeno

1. října 2012

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • D9127C00002
  • 2008-007420-26

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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