E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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.
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | 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). |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |