Status:
TERMINATED
Prospective Randomized Open Label Study of the Treatment of Therapy-associated Diarrhea During Percutaneous Radiation Therapy of the Small Pelvis. - Comparison of Loperamide and Tincture of Opium -
Lead Sponsor:
Philipps University Marburg
Collaborating Sponsors:
Maros Arznei GmbH
Conditions:
Diarrhea
Enteritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Therapy-associated diarrhea during radiation therapy of small pelvis (including enteritis as a result of radiation therapy and enteritis as a result of radiation- and chemotherapy) is a common problem...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
- Pseudomembranous colitis/ antibiotic-associated colitis
- Diarrhea associated with fever and bloody stools
- Acute increase of colitis ulcerous 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 hypothyroidism
- 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 involvement
- Participation in an other clinical trial at the same time
Key Trial Info
Start Date :
March 5 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 29 2008
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00444093
Start Date
March 5 2007
End Date
February 29 2008
Last Update
May 11 2023
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