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Completed

NCT Number: NCT01019928

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

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

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Key information

Conditions

Sensitivity in Esophagus Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Århus C, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD1386

Drug

95 mg, oral solution, single dose

Placebo to AZD1386

Drug

Placebo, oral solution, single dose

Primary outcomes

  1. Time to Visual Analogue Scale 7 (VAS7) During Thermal Stimulation at 1.5 Hours Post-Dose.

    Time frame: 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:

    • = vague perception of mild sensation
    • = definite perception of mild sensation
    • = vague perception of moderate sensation
    • = definite perception of moderate sensation

    For painful sensations the patients will use the scale from 5-10 anchored at:

    • = pain detection
    • = slight pain
    • = moderate pain
    • = medium pain intensity
    • = intense pain
    • = unbearable pain

Secondary outcomes

  1. Time to Visual Analogue Scale 7 (VAS7) During Thermal Stimulation at 0.5 Hours Post Dose

    Time frame: 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:

    • = vague perception of mild sensation
    • = definite perception of mild sensation
    • = vague perception of moderate sensation
    • = definite perception of moderate sensation

    For painful sensations the patients will use the scale from 5-10 anchored at:

    • = pain detection
    • = slight pain
    • = moderate pain
    • = medium pain intensity
    • = intense pain
    • = unbearable pain

  2. Time to Visual Analogue Scale 7 (VAS7) During Thermal Stimulation at 2.5 Hours Post Dose

    Time frame: 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:

    • = vague perception of mild sensation
    • = definite perception of mild sensation
    • = vague perception of moderate sensation
    • = definite perception of moderate sensation

    For painful sensations the patients will use the scale from 5-10 anchored at:

    • = pain detection
    • = slight pain
    • = moderate pain
    • = medium pain intensity
    • = intense pain
    • = unbearable pain

  3. Volume at Visual Analogue Scale 7 (VAS7) During Mechanical Stimulation at 0.5 Hours Post Dose

    Time frame: 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:

    • = vague perception of mild sensation
    • = definite perception of mild sensation
    • = vague perception of moderate sensation
    • = definite perception of moderate sensation

    For painful sensations the patients will use the scale from 5-10 anchored at:

    • = pain detection
    • = slight pain
    • = moderate pain
    • = medium pain intensity
    • = intense pain
    • = unbearable pain

  4. Volume at Visual Analogue Scale 7 (VAS7) During Mechanical Stimulation at 1.5 Hours Post-Dose

    Time frame: 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:

    • = vague perception of mild sensation
    • = definite perception of mild sensation
    • = vague perception of moderate sensation
    • = definite perception of moderate sensation

    For painful sensations the patients will use the scale from 5-10 anchored at:

    • = pain detection
    • = slight pain
    • = moderate pain
    • = medium pain intensity
    • = intense pain
    • = unbearable pain

  5. Volume at Visual Analogue Scale 7 (VAS7) During Mechanical Stimulation at 2.5 Hours Post-Dose.

    Time frame: 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:

    • = vague perception of mild sensation
    • = definite perception of mild sensation
    • = vague perception of moderate sensation
    • = definite perception of moderate sensation

    For painful sensations the patients will use the scale from 5-10 anchored at:

    • = pain detection
    • = slight pain
    • = moderate pain
    • = medium pain intensity
    • = intense pain
    • = unbearable pain

  6. Current at Visual Analogue Scale 7 (VAS7) During Electrical Stimulation 0.5 Hours Post Dose

    Time frame: 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:

    • = vague perception of mild sensation
    • = definite perception of mild sensation
    • = vague perception of moderate sensation
    • = definite perception of moderate sensation

    For painful sensations the patients will use the scale from 5-10 anchored at:

    • = pain detection
    • = slight pain
    • = moderate pain
    • = medium pain intensity
    • = intense pain
    • = unbearable pain

  7. Current at Visual Analogue Scale 7 (VAS7) During Electrical Stimulation at 1.5 Hours Post Dose

    Time frame: 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:

    • = vague perception of mild sensation
    • = definite perception of mild sensation
    • = vague perception of moderate sensation
    • = definite perception of moderate sensation

    For painful sensations the patients will use the scale from 5-10 anchored at:

    • = pain detection
    • = slight pain
    • = moderate pain
    • = medium pain intensity
    • = intense pain
    • = unbearable pain

  8. Current at Visual Analogue Scale 7 (VAS7) During Electrical Stimulation at 2.5 Hours Post Dose

    Time frame: 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:

    • = vague perception of mild sensation
    • = definite perception of mild sensation
    • = vague perception of moderate sensation
    • = definite perception of moderate sensation

    For painful sensations the patients will use the scale from 5-10 anchored at:

    • = pain detection
    • = slight pain
    • = moderate pain
    • = medium pain intensity
    • = intense pain
    • = unbearable pain

  9. AUCt

    Time frame: 0 to 4 hours post dose

    Area under the plasma concentration curve from time zero to the last quantifiable concentration

  10. Cmax

    Time frame: 0 to 4 hours post dose

    Maximum plasma concentration

  11. Tmax

    Time frame: 0 to 4 hours post dose

    Time of maximum plasma concentration

  12. SBP

    Time frame: 1.5 hours post dose

    Supine Systolic Blood Pressure at 1.5 hours post dose

  13. DBP

    Time frame: 1.5 hours post dose

    Supine Diastolic Blood Pressure at 1.5 hours post dose

  14. Pulse

    Time frame: 1.5 hours post dose

    Supine Pulse at 1.5 hours post dose

  15. QTcF

    Time frame: 1.5 hours post dose

    QT interval corrected for heart rate using Fredericia formula(QTcF) at 1.5 hours post dose

  16. Body Temperature

    Time frame: 1.5 hours post dose

    Oral Body Temperature at 1.5 hours post dose

  17. Clinically Relevant Change of Laboratory Variables

    Time frame: Pre-entry to follow-up

    Number of participants with clinically relevant change of laboratory variables(clinical chemistry, haematology and urinalysis parameters)

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Nov 25, 2009
Registry last updated
Nov 9, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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