NCT01019928

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2009

Shorter than P25 for phase_2

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

November 20, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 25, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

November 9, 2012

Completed
Last Updated

November 9, 2012

Status Verified

October 1, 2012

Enrollment Period

1.2 years

First QC Date

November 20, 2009

Results QC Date

January 27, 2012

Last Update Submit

October 10, 2012

Conditions

Sensitivity in Esophagus

Keywords

GERDpatientesophaguspain

Outcome Measures

Primary Outcomes (1)

  • Time to Visual Analogue Scale 7 (VAS7) During Thermal Stimulation at 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

Secondary Outcomes (17)

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

    0.5 hours post dose

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

    2.5 hours post dose

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

    0.5 hours post dose

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

    1.5 hours post dose

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

    2.5 hours post dose

  • +12 more secondary outcomes

Study Arms (2)

First AZD1386, then washout, then placebo

EXPERIMENTAL
Drug: AZD1386Drug: Placebo to AZD1386

First placebo, then washout, then AZD1386

EXPERIMENTAL
Drug: AZD1386Drug: Placebo to AZD1386

Interventions

AZD1386DRUG

95 mg, oral solution, single dose

First AZD1386, then washout, then placeboFirst placebo, then washout, then AZD1386
Placebo to AZD1386DRUG

Placebo, oral solution, single dose

First AZD1386, then washout, then placeboFirst placebo, then washout, then AZD1386

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Provision of signed informed consent form
  • BMI 18.5-35.0, inclusive
  • Continuous PPI treatment for GERD during the last 4 weeks

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Research Site

Århus C, Denmark

Location

Research Site

Gothenburg, Västra Götaland County, Sweden

Location

Related Publications (1)

  • Krarup AL, Ny L, Gunnarsson J, Hvid-Jensen F, Zetterstrand S, Simren M, Funch-Jensen P, Hansen MB, Drewes AM. Randomized clinical trial: inhibition of the TRPV1 system in patients with nonerosive gastroesophageal reflux disease and a partial response to PPI treatment is not associated with analgesia to esophageal experimental pain. Scand J Gastroenterol. 2013 Mar;48(3):274-84. doi: 10.3109/00365521.2012.758769. Epub 2013 Jan 16.

    PMID: 23320520DERIVED

MeSH Terms

Conditions

Gastroesophageal RefluxPain

Interventions

AZD1386

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Gerard Lynch
Organization
AstraZeneca
aztrial_results_posting@astrazeneca.com
+44 1625 518062

Study Officials

  • Marie Sundin

    AstraZeneca R&D, Mölndal, Sweden

    STUDY DIRECTOR

  • Peter Funch-Jensen,, MD, PhD

    Aarhus Hospital, Dept of Surgical Gastroenterology, Aarhus, Denmark

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2009

First Posted

November 25, 2009

Study Start

November 1, 2009

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

November 9, 2012

Results First Posted

November 9, 2012

Record last verified: 2012-10

Locations

SE(1)DK(1)