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

10 października 2012 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

14

Faza

  • Faza 2

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Dania
      • Århus C, Dania
        • Research Site
  • Szwecja
    • Vastra Gotaland
      • Goteborg, Vastra Gotaland, Szwecja
        • Research Site

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 70 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Zadanie krzyżowe
  • Maskowanie: Potroić

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: First AZD1386, then washout, then placebo
Lek: AZD1386
95 mg, oral solution, single dose
Lek: Placebo to AZD1386
Placebo, oral solution, single dose
Eksperymentalny: First placebo, then washout, then AZD1386
Lek: AZD1386
95 mg, oral solution, single dose
Lek: Placebo to AZD1386
Placebo, oral solution, single dose

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Time to Visual Analogue Scale 7 (VAS7) During Thermal Stimulation at 1.5 Hours Post-Dose.
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Time to Visual Analogue Scale 7 (VAS7) During Thermal Stimulation at 0.5 Hours Post Dose
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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.
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 0 to 4 hours post dose
Maximum plasma concentration
0 to 4 hours post dose
Tmax
Ramy czasowe: 0 to 4 hours post dose
Time of maximum plasma concentration
0 to 4 hours post dose
SBP
Ramy czasowe: 1.5 hours post dose
Supine Systolic Blood Pressure at 1.5 hours post dose
1.5 hours post dose
DBP
Ramy czasowe: 1.5 hours post dose
Supine Diastolic Blood Pressure at 1.5 hours post dose
1.5 hours post dose
Pulse
Ramy czasowe: 1.5 hours post dose
Supine Pulse at 1.5 hours post dose
1.5 hours post dose
QTcF
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

AstraZeneca

Śledczy

  • Dyrektor Studium: Marie Sundin, AstraZeneca R&D, Mölndal, Sweden
  • Główny śledczy: Peter Funch-Jensen,, MD, PhD, Aarhus Hospital, Dept of Surgical Gastroenterology, Aarhus, Denmark

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 listopada 2009

Zakończenie podstawowe (Rzeczywisty)

1 stycznia 2011

Ukończenie studiów (Rzeczywisty)

1 stycznia 2011

Daty rejestracji na studia

Pierwszy przesłany

20 listopada 2009

Pierwszy przesłany, który spełnia kryteria kontroli jakości

24 listopada 2009

Pierwszy wysłany (Oszacować)

25 listopada 2009

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

9 listopada 2012

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

10 października 2012

Ostatnia weryfikacja

1 października 2012

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • D9127C00002
  • 2008-007420-26

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Sensitivity in Esophagus

Badania kliniczne na AZD1386

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