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Clinical Trial Details

Overview

Research Study Summary

A clinical research study of PPC-5650 and Placebo for the treatment of Pain

Research Study Title

A Randomized, Double-blind, Cross-over Trial in Patients With Irritable Bowel Syndrome Investigating the Efficacy and Safety of PPC-5650 on Sensation and Pain During Standardized Stimulation of the Rectosigmoid

Purpose

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.

To Learn more
Phase

1

Gender

Both Male and Female

Age

18 to 70 Years

Overall Status

Recruiting

Lead Sponsor

Aros Pharma ApS

Duration

9 Months

Facility Type

N/A

Eligibility

Both Male and Female ages 18 Years to 70 Years

Inclusion Criteria:

  • Signed informed consent

  • Postmenopausal women or women who have undergone hysterectomy, and males between 18 and 70 years of age

  • Pain intensity during pain attack should be > 5 on the GSRS questionnaire

  • Hypersensitivity within the last 2 years measured with the barostat

  • Patients able to co-operate and tolerate the experimental procedures (as assessed in the training visit)

  • Patients on stable medication

  • Only patients that do not take over the counter medication 24h before the two study sessions

Exclusion Criteria:

  • Any history of, or current condition or medication that, as judged by the investigator, may affect gastrointestinal function and the interpretation of the clinical data

  • Any clinically relevant abnormal values from the laboratory tests on hematology, clinical chemistry, urine analyses and/or faeces testing, as judged by the investigator.

  • Chronic extraintestinal pain dominating the clinical history

  • Any known biochemical or structural abnormality of the digestive tract such as gluten enteropathy, bile acid diarrhea, lymphocytic colitis and/or collagenous colitis, Chronic inflammatory bowel diseases, chronic pancreatitis

  • Major intra-abdominal surgery; appendectomy and minor laparoscopic gynecological surgery acceptable.

  • Any planned surgical intervention within the duration of the trial.

  • Any abdominal surgery

  • Participation in any other clinical trial within three months prior to the pre-screening visit.

  • Alcohol or drug abuse.

Site Locations (1)

Country State City Zip Facility and Contact
Sweden Gothenburg SE-413 45 Department of Gastroenterology
Magnus Simrén, Professor
0046-31-342 8107
magnus.simren@medicin.qu.se

Magnus Simrén, Professor
Principal Investigator

NCT ID: NCT01449487

Date Last Changed: January 19, 2012

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