Irritable Bowel Disease
Conditions
Interventions
Product Name: LY307161
Product Code: LY307161
Pharmaceutical Form: Powder for injection*
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous
Sponsors
Gastrotech Pharma A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed Informed Consent 2. Females and males 18-70 years of age 3. Patients suffering from IBS according to Rome II criteria. 4. Ambulatory treated patients. 5. Frequency of abdominal pain attacks > 4 per month for > 2 month. 6. Pain intensity during pain attack should be >40 mm on a 100 mm VAS scale. 7. Patients able to co-operate and tolerate the subcutaneous injection administration technique. 8. Pain duration for at least 2 hours/attack. 9. Ability and willingness to visit the study site within 1 hour from pain attack initiation.* * Allowing the 2-hour evaluation after drug administration to be concluded within the average time frame of a pain attack. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. 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, not violating the restrictions under section 13.2.(see protocol) 2. Any clinically relevant abnormal values from the laboratory tests on hematology, clinical chemistry, urine analyses and/or faeces testing, as judged by the Investigator. 3. Any known or suspected allergy or hypersensitivity that may interfere with the study objectives, as judged by the Investigator. 4. Any chronic pain syndrome, other than IBS related abdominal pain. 5. Any known biochemical or structural abnormality of the digestive tract.* *Such as gluten enteropathy, bile acid diarrhea, lymphocytic colitis and/or collagenous colitis, Crohn´s disease, ulcerative colitis, lactose intolerance, pancreatis cholecystectomy ventricular resection and other large intraintraperitoneal surgery. Smaller abdominal surgeries such as appendectomy or laparascopic gynecological interventions are not included in this group. 6. Any planned surgical intervention within the duration of the trial. 7. Any abdominal surgery within 6 month before study start. 8. Pregnant (positive U-HCG), or nursing women. 9. Fertile women not using reliable contraceptive methods. 10. Drug abuse within the last 2 years. 11. Alcohol abuse, defined as consumption >60 cl liqueur per week (= 3 bottles, 75 cl of 12% wine) within the last 2 years. 12. Participation in any other clinical trial within one month prior to the screening visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To test the hypothesis that LY307161, will reduce the acute abdominal pain attacks in patients suffering from irritable bowel syndrome (IBS). The primary endpoint will be the proportion of responders after each treatment, as estimated from pain relief ratings.;Secondary Objective: To compare other measures of pain relief; to describe onset and duration of pain relief; to compare different measures of pain intensity; to explore whether the proportion of Pain Relief Response differs between subgroups of patients (e.g. patients with predominantly diarrhea or predominantly constipation), gender, food intake induced pain; to compare patient global impressions; and to evaluate the safety of LY307161.;Primary end point(s): The primary efficacy endpoint is Response, defined as a patient that shows an area under the pain relief curve >50% of the maximum possible Total Pain Relief (TOTPAR) during 10-60 minutes after one study drug administration (Pain Relief Response = >50% TOTPAR). | — |
Countries
Germany
Outcome results
None listed