A Study of the Effect of ONO-8539 on Oesophageal Pain Hypersensitivity in Patients With Non-erosive Reflux Disease
This study is currently recruiting participants.
Verified October 2012 by Ono Pharmaceutical Co. Ltd
Sponsor:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier:
NCT01707901
First received: October 10, 2012
Last updated: May 1, 2013
Last verified: October 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
A random controlled study to investigate the effect of a new drug, ONO-8539, on oesophageal pain hypersensitivity in patients with gastric reflux disease
| Condition | Intervention | Phase |
|---|---|---|
|
GERD |
Drug: ONO-8539 Other: Placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Randomised, Double-blind, Placebo-controlled, Two-period Crossover Study to Investigate the Effect of ONO-8539 on Oesophageal Pain Hypersensitivity in Patients With Non-erosive Reflux Disease |
Resource links provided by NLM:
Further study details as provided by Ono Pharmaceutical Co. Ltd:
Primary Outcome Measures:
- To evaluate the effect of ONO-8539 on oesophageal pain hypersensitivity to acid perfusion [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]Daily, through a pain assessment score chart
Secondary Outcome Measures:
- To evaluate the effect of ONO-8539 on subject-reported symptoms of GERD [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]Daily, by observation
- To assess the tolerability of ONO-8539 [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]Daily, through observation and a pain score chart
- To investigate the effect of ONO-8539 on oesophageal pain hypersensitivity to electrical stimulation [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]Daily, through observation and a pain score chart
- To evaluate the effect of ONO-8539 on quality of life [ Time Frame: 30 Days ] [ Designated as safety issue: No ]Daily, through Quality of life assessment questionnaires
- To investigate the pharmacokinetics of ONO-8539 [ Time Frame: 30 Days ] [ Designated as safety issue: No ]AUC, Cmax, Tmax
- To investigate the association among the changes in pharmacodynamics of ONO-8539 [ Time Frame: 30 Days ] [ Designated as safety issue: No ]Daily observation and through Quality of life assessment questionnaires
- To investigate the association between the changes in pharmacodynamic parameters of ONO-8539 and the plasma concentrations of ONO-8539 [ Time Frame: 30 Days ] [ Designated as safety issue: No ]Correlation between pharmacokinetic results and study specific procedure results
- To evaluate the use of antacid in each treatment group [ Time Frame: 30 Days ] [ Designated as safety issue: No ]Daily record of frequency of use
- To assess the safety of ONO-8539 [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
- To investigate the association among the changes in psychological parameters of ONO-8539 [ Time Frame: 30 days ] [ Designated as safety issue: No ]Quality of life assessment
| Estimated Enrollment: | 30 |
| Study Start Date: | December 2012 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: ONO-8539
ONO-8539
|
Drug: ONO-8539
Treatment
Other Name: Experimental
|
|
Placebo Comparator: Placebo
Placebo
|
Other: Placebo
Placebo
|
Detailed Description:
This is a Randomised, Double-blind, Placebo-controlled, Two-period Crossover Study to Investigate the Effect of ONO-8539 on Oesophageal Pain Hypersensitivity in Patients With Non-erosive Reflux Disease
Eligibility| Ages Eligible for Study: | 18 Years to 64 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male and female subjects aged 18-64 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 double dose of proton pump inhibitors and demonstrate oesophageal hypersensitivity following distal oesophageal acid perfusion.
Exclusion Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01707901
Contacts
| Contact: Ono Pharma UK Ltd | +44 (0)2074214920 | |
| Contact: Study Director |
Locations
| Belgium | |
| Leuven Clinical site | Not yet recruiting |
| Leuven, Belgium, B-3000 | |
| United Kingdom | |
| London Clinical site | Recruiting |
| London, United Kingdom, E1 2AJ | |
Sponsors and Collaborators
Ono Pharmaceutical Co. Ltd
Investigators
| Study Director: | Study Director | Clinical Department, Ono Pharmaceutical Co. Ltd |
More Information
No publications provided
| Responsible Party: | Ono Pharmaceutical Co. Ltd |
| ClinicalTrials.gov Identifier: | NCT01707901 History of Changes |
| Other Study ID Numbers: | ONO-8539POE011 |
| Study First Received: | October 10, 2012 |
| Last Updated: | May 1, 2013 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency Belgium: Federal Agency for Medicinal Products and Health Products |
Additional relevant MeSH terms:
|
Hypersensitivity Gastroesophageal Reflux Immune System Diseases Esophageal Motility Disorders |
Deglutition Disorders Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013