Status:
COMPLETED
Investigation of Efficacy and Safety of PPC-5650 to Experimental Induced Sensation and Pain in the Rectosigmoid
Lead Sponsor:
Aros Pharma ApS
Conditions:
Pain
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief 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 m...
Detailed Description
Clinical pain and especially visceral pain is diffuse and widespread, and normally associated with many autonomic symptoms that may blur the characterization of disease in clinical practice. When trea...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01449487
Start Date
January 1 2012
End Date
May 1 2013
Last Update
May 21 2014
Active Locations (1)
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1
Department of Gastroenterology
Gothenburg, Sweden, SE-413 45