Investigation of Efficacy and Safety of PPC-5650 to Experimental Induced Sensation and Pain in the Rectosigmoid

NCT01449487 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2014-05-21

No results posted yet for this study

Summary

Irritable Bowel Syndrome (IBS) is a gastrointestinal disorder characterized by chronic abdominal pain and altered bowel habits in the absence of any organic cause. Patients with IBS visit the doctor more frequently, use more diagnostic tests, consume more medications, miss more workdays, and consume more overall direct costs than patients without IBS. More specific treatment of the localized symptoms of IBS is therefore needed, why the present study will investigate the effect and mechanisms of PPC-5650. PPC-5650 is a new chemical entity that can negatively modulate the activity of Acid sensing ion channels (ASICs). It is a potent low molecular weight inhibitor for this class of ion channels described to date.

It is hypothesized that safety, efficacy and mechanisms of local administration in the rectum of PPC-5650 can be evaluated by use of experimental induced sensation and pain in the rectum.

Conditions

Pain

Interventions

DRUG

PPC-5650

Solution for administration in the rectum Single dose of 25µg/ml at a volume of 50ml

DRUG

Placebo

Solution for administration in the rectum Identical tp active solution but without active drug

Sponsors & Collaborators

Aros Pharma ApS
lead INDUSTRY

Principal Investigators

Asbjørn M Drewes, Professor · Mech-Sense, Aalborg Hospital, Aalborg, Denmark

Study Design

Allocation: RANDOMIZED
Purpose: BASIC_SCIENCE
Masking: DOUBLE
Model: CROSSOVER

Eligibility

Min Age: 18 Years
Max Age: 70 Years
Sex: ALL
Healthy Volunteers: No

Timeline & Regulatory

Start: 2012-01-31
Primary Completion: 2013-05-31
Completion: 2013-05-31

Countries

Sweden

Study Locations

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Entities

Drugs

Placebo

Diseases

Pain