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

10. oktober 2012 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

14

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Danmark
      • Århus C, Danmark
        • Research Site
  • Sverige
    • Vastra Gotaland
      • Goteborg, Vastra Gotaland, Sverige
        • Research Site

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: First AZD1386, then washout, then placebo
Medicin: AZD1386
95 mg, oral solution, single dose
Medicin: Placebo to AZD1386
Placebo, oral solution, single dose
Eksperimentel: First placebo, then washout, then AZD1386
Medicin: AZD1386
95 mg, oral solution, single dose
Medicin: Placebo to AZD1386
Placebo, oral solution, single dose

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time to Visual Analogue Scale 7 (VAS7) During Thermal Stimulation at 1.5 Hours Post-Dose.
Tidsramme: 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

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

AstraZeneca

Efterforskere

  • Studieleder: Marie Sundin, AstraZeneca R&D, Mölndal, Sweden
  • Ledende efterforsker: Peter Funch-Jensen,, MD, PhD, Aarhus Hospital, Dept of Surgical Gastroenterology, Aarhus, Denmark

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. november 2009

Primær færdiggørelse (Faktiske)

1. januar 2011

Studieafslutning (Faktiske)

1. januar 2011

Datoer for studieregistrering

Først indsendt

20. november 2009

Først indsendt, der opfyldte QC-kriterier

24. november 2009

Først opslået (Skøn)

25. november 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

9. november 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. oktober 2012

Sidst verificeret

1. oktober 2012

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • D9127C00002
  • 2008-007420-26

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Sensitivity in Esophagus

Kliniske forsøg med AZD1386

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