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

10 ottobre 2012 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

14

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Danimarca
      • Århus C, Danimarca
        • Research Site
  • Svezia
    • Vastra Gotaland
      • Goteborg, Vastra Gotaland, Svezia
        • Research Site

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 70 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: First AZD1386, then washout, then placebo
Droga: AZD1386
95 mg, oral solution, single dose
Droga: Placebo to AZD1386
Placebo, oral solution, single dose
Sperimentale: First placebo, then washout, then AZD1386
Droga: AZD1386
95 mg, oral solution, single dose
Droga: Placebo to AZD1386
Placebo, oral solution, single dose

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Time to Visual Analogue Scale 7 (VAS7) During Thermal Stimulation at 1.5 Hours Post-Dose.
Lasso di tempo: 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

Misure di risultato secondarie

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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

AstraZeneca

Investigatori

  • Direttore dello studio: Marie Sundin, AstraZeneca R&D, Mölndal, Sweden
  • Investigatore principale: Peter Funch-Jensen,, MD, PhD, Aarhus Hospital, Dept of Surgical Gastroenterology, Aarhus, Denmark

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 novembre 2009

Completamento primario (Effettivo)

1 gennaio 2011

Completamento dello studio (Effettivo)

1 gennaio 2011

Date di iscrizione allo studio

Primo inviato

20 novembre 2009

Primo inviato che soddisfa i criteri di controllo qualità

24 novembre 2009

Primo Inserito (Stima)

25 novembre 2009

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

9 novembre 2012

Ultimo aggiornamento inviato che soddisfa i criteri QC

10 ottobre 2012

Ultimo verificato

1 ottobre 2012

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • D9127C00002
  • 2008-007420-26

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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