E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Therapy-associated diarrhea during radiaton therapy of small pelvis (including enteritis as a result of radiation therapy and enteritis as a result of radiation- and chemotherapy). |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10012735 |
E.1.2 | Term | Diarrhoea |
|
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 |
In this study efficacy of loperamide and tincture of opium is linked to the respective proportions of patients where diarrhoea of grade > 2 is successfully averted during (cancer) therapy. Should diarrhoea of grade > 2 occur despite the respective drug treatment, the corresponding drug treatment is assessed as ineffective in that case und the patient is defined as non-respomder.
|
|
E.2.2 | Secondary objectives of the trial |
- Scores from the EORTC-QLQ-C30 - Body composition data (BMI, proportions of fat and water)
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• age ≥ 18 years • patients who will undergo a percutaneous radiation therapy in the area of the small pelvis. This includes patients with following malignancies: rectal carcinoma, prostate carcinoma, endometrial carcinoma, cervix carcinoma. • Diarrhea grade 1 and grade 2 (Classification NCI-CTCAE Version 3.0) • ECOG-Grade 0-2 • Enlightenment and written declaration of consent to the participation.
|
|
E.4 | Principal exclusion criteria |
• Pregnant patients or patients in lactation period. • Severe dysfunction of liver or kidneys • Injury or illness of brain e.g. increased intracranial pressure, cerebral arteriosclerosis • Epilepsy • Hypersensitivity to components of loperamide or tincture of opium • Ileus • Toxic megacolon • Pseudmembraneous colitis/ antibiotic-associated colitis • Diarrhea associated with fever and bloody stools • Acute increase of colitis ulcerosa or bacterial colitis caused by invasive pathogenes • Severe respiratory dysfunction or severely limited lung function e.g. bronchial asthma, bronchitis • Dysfunctional draining of biliary area, biliary colics. • Concomitant or earlier addiction of alcohol or opiates • Severe heart disease • Pheochromocytoma • Acute hepatic porphyria • Cor pulmonale • Morbus Addison • Severe hypothyreoidism • Organisational problems or circumstances which prevent a complete collection of required data • artificial anus • participation in a clinical trial within the last 30 days before inclusion
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Primary Endpoint: In this study efficacy of loperamide and tincture of opium is linked to the respective proportions of patients where diarrhea of grade > 2 is successfully averted during (cancer) therapy. Should diarrhoea of grade > 2 occur despite the respective drug treatment, the corresponding drug treatment is assessed as ineffective in that case und the patient is defined as non-responder.
Secondary Endpoints: - Scores from the EORTC-QLQ-C30 - Body composition data (BMI, proportions of fat and water)
|
|
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 | Yes |
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 | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
loperamide (Imodium® capsulate). |
|
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
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 | No |
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
|
The observation period covers from five weeks following the first day of radiation therapy. After beginning of first diarrhea grade ≥ II the patient receive the randomised treatment. Also after amelioration of symptoms the application will be recommended during the period of radiation therapy. An observation on day 90 is scheduled
|
|
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 | 18 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 18 |