DiarrheaPhase 3LoopNCT00444093
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 -
A Phase 3 study testing Opii normata treatment and Loperamid Treatment in people with Diarrhea and Enteritis, run by Philipps University Marburg.
Trial 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 in multimodal cancer therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Opii normata treatment and Loperamid Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- 5 Mar 2007to 29 Feb 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 23Show fewer
- 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
About this study
Official title: 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
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 in multimodal cancer therapy. We investigate the therapeutic effect of either loperamide or tinctura opii in therapy- associated diarrhea in patients who receive radiation therapy of the small pelvis with or without chemotherapy.
- Being tested
- Opii normata treatment, Loperamid Treatment
- Keywords
- radiation therapy, diarrhea, enteritis, supportive therapy, therapy associated diarrhea, therapy associated enteritis, radiation therapy of the small pelvis
- Medical subject headings
- Diarrhea, Enteritis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opii normata treatmentDrug
After beginning of diarrhea grade 1:
5 drops tincture of opium three times a day
After beginning of diarrhea grade 2:
Intensive therapy with 15 drops tincture of opium three times a day.
Loperamid TreatmentDrug
All patients who receive as a result of randomisation loperamide
After beginning of diarrhea grade 1:
Initial 4mg and 2mg after any unformed stool. The maximum dose amounts to16mg per day.
After beginning of diarrhea grade 2:
Intensive therapy with 2mg loperamide every 2 h. The maximum dose amounts to 16mg per day.
| Study group | Role | What they receive |
|---|---|---|
| Opii normata treatment | Experimental | Treamtment with opii normata in case of diarrhea Receives: Drug: Opii normata treatment |
| Loperamid Treatment | Experimental | Treatment with Loperamid in case of diarrhea Receives: Drug: Loperamid Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Efficacy
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.
Measured: 90 days
Secondary outcomes (2)
Quality of life EORTC-QLQ C30
Quality of life will be assessed with the EORTC-QLQ C30 questionnaire
Measured: 90 days
Diarrhea Assessment
The quality and quantity of diarrhea will be assessed with a questionnaire
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2007 (estimated)
- Study start5 Mar 2007
- Primary completion29 Feb 2008
- Study completion29 Feb 2008
Why it stopped: bad recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiarrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparision between treatment with Tinctura Opii normata and Loperamid in patients with therapy-associated diarrhea during radiaton therapy of small pelvis
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philipps University Marburg
- Sponsor type
- University, hospital or other
- Collaborators
- Maros Arznei GmbH
- Responsible party
- Sponsor
- Investigators
- Michael Bieker, MD, Principal investigator, center of radiology, departement of radiation therapy, clinical center Giessen and Marburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00444093
- Sponsor's protocol ID
- 2006-002948-28
- Other IDs
- KKS-73-05
- Acronym
- Loop
- Status last verified
- Apr 2018
- First submitted
- 6 Mar 2007
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00444093
- Acronym / sponsor ID
- Loop / 2006-002948-28
- Keywords
- radiation therapy, diarrhea, enteritis, supportive therapy, therapy associated diarrhea, therapy associated enteritis, radiation therapy of the small pelvis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: bad recruitment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Philipps University MarburgUniversity, hospital or other
- Collaborators
- Maros Arznei GmbH
- Study start
- 5 Mar 2007 (actual)
- Primary completion
- 29 Feb 2008 (actual)
- Study completion
- 29 Feb 2008 (actual)
- First posted
- 7 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 in multimodal cancer therapy. We investigate the therapeutic effect of either loperamide or tinctura opii in therapy- associated diarrhea in patients who receive radiation therapy of the small pelvis with or without chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Comparision between treatment with Tinctura Opii normata and Loperamid in patients with therapy-associated diarrhea during radiaton therapy of small pelvis
| Arm | Type | Receives |
|---|---|---|
| Opii normata treatment | Experimental | Drug: Opii normata treatmentTreamtment with opii normata in case of diarrhea |
| Loperamid Treatment | Experimental | Drug: Loperamid TreatmentTreatment with Loperamid in case of diarrhea |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Opii normata treatmentAfter beginning of diarrhea grade 1: 5 drops tincture of opium three times a day After beginning of diarrhea grade 2: Intensive therapy with 15 drops tincture of opium three times a day. | Drug | Opii normata treatment |
| Loperamid TreatmentAll patients who receive as a result of randomisation loperamide After beginning of diarrhea grade 1: Initial 4mg and 2mg after any unformed stool. The maximum dose amounts to16mg per day. After beginning of diarrhea grade 2: Intensive therapy with 2mg loperamide every 2 h. The maximum dose amounts to 16mg per day. | Drug | Loperamid Treatment |
Primary outcome
Treatment Efficacy
Time frame: 90 days
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.
2 secondary outcomes
Quality of life EORTC-QLQ C30
Time frame: 90 days
Diarrhea Assessment
Time frame: 90 days
Results and safety
The study was stopped early (reason given: bad recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Bieker, MD principal investigator
center of radiology, departement of radiation therapy, clinical center Giessen and Marburg
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Opii normata treatment and Loperamid Treatment in people with Diarrhea and Enteritis, run by Philipps University Marburg.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: bad recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Efficacy (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2023; AzTrials last refreshed its copy on 7 Nov 2026.