NCT01707901

Brief Summary

A random controlled study to investigate the effect of a new drug, ONO-8539, on oesophageal pain hypersensitivity in patients with gastric reflux disease

Trial Health

85
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_1

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

First Submitted

Initial submission to the registry

October 10, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 16, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Last Updated

October 14, 2015

Status Verified

October 1, 2015

Enrollment Period

1.8 years

First QC Date

October 10, 2012

Last Update Submit

October 13, 2015

Conditions

GERD

Keywords

GERD

Outcome Measures

Primary Outcomes (1)

  • To evaluate the effect of ONO-8539 on oesophageal pain hypersensitivity to acid perfusion

    Daily, through a pain assessment score chart

    28 Days

Secondary Outcomes (10)

  • To evaluate the effect of ONO-8539 on subject-reported symptoms of GERD

    28 Days

  • To assess the tolerability of ONO-8539

    28 Days

  • To investigate the effect of ONO-8539 on oesophageal pain hypersensitivity to electrical stimulation

    28 Days

  • To evaluate the effect of ONO-8539 on quality of life

    28 Days

  • To investigate the pharmacokinetics of ONO-8539

    28 Days

  • +5 more secondary outcomes

Study Arms (2)

ONO-8539

EXPERIMENTAL

ONO-8539

Drug: ONO-8539

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

ONO-8539DRUG

Treatment

Also known as: Experimental
ONO-8539
PlaceboOTHER

Placebo

Placebo

Eligibility Criteria

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

You may qualify if:

  • Male and female subjects aged 18-70 years inclusive with confirmed GERD and normal oesophageal mucosa will be enrolled in this study. Subjects demonstrate moderate intensity heartburn while being on a stable dose of proton pump inhibitor and demonstrate oesophageal hypersensitivity following distal oesophageal acid perfusion.

You may not qualify if:

  • Subjects will be excluded if they have a motility disorder, are not able to tolerate study procedures or have had GI surgery or have a condition that would affect the study results. Subjects with functional heartburn, acute GI symptoms, endoscopic or manometric abnormality or a protocol-specified cardiovascular condition will not be enrolled.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Leuven Clinical site

Leuven, Leuven, B-3000, Belgium

Location

London Clinical site

London, London, E1 2AJ, United Kingdom

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

ONO-8539

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Study Director

    Clinical Department, Ono Pharmaceutical Co. Ltd

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2012

First Posted

October 16, 2012

Study Start

December 1, 2012

Primary Completion

October 1, 2014

Last Updated

October 14, 2015

Record last verified: 2015-10

Locations

BE(1)GB(1)