Rectal CancerPhase 3NCT02266849
Loperamide vs. Placebo's Effect on Ileostomy Output: A Clinical Randomized Blinded Cross-over Study
A Phase 3 study testing Loperamide in people with Rectal Cancer and Ulcerative Colitis, run by Odense University Hospital at 1 site in Denmark.
Trial summary
Clinical experience show limited effect of the drug Loperamide used to decrease output in stoma patients. Therefore the investigators see the need for a randomized blinded clinical trial to determine the effect of Loperamide opposite Placebo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer, Ulcerative Colitis, Short Bowel Syndrome
- What is being tested?
- Loperamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2014to Aug 2015
- 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
- Operation for rectal cancer or ulcerative colitis an ileostomy (loop or end ileostomy within the last 7 days) OR
- ileostomy patient with contact to the stoma clinic OR
- Short bowel syndrome with a permanent ileostomy
- signed consent form
Who cannot join
- Complications associated with surgery
- Non-radical surgery
- Chemotherapy
- Poor compliance
- Other serious illness
Trial locations and contacts
1 site in 1 country.
About this study
Clinical experience show limited effect of the drug Loperamide used to decrease output in stoma patients. Therefore the investigators see the need for a randomized blinded clinical trial to determine the effect of Loperamide opposite Placebo.
Loperamide will be evaluated in relation to the following parameters
- Change in ileostomy output in g/day in relation to oral intake
- Quantification of the change in intestinal transit time using a radiopaque marker
- The patient´s own assessment on which period they received Loperamide or Placebo
Read the detailed description
The aim of this study is to quantify the effect of Loperamide on ileostomy output in patients operated for rectal cancer, ulcerative colitis and in patients with short bowl syndrome. These patients are recruited through The Department of Surgery and The Department of Gastroenterology, University Hospital Odense. The effect of Loperamide will be evaluated against Placebo in relation to the following parameters:
- Change in ileostomy output in g/day in relation to oral intake
- Quantification of the change in intestinal transit time using a radiopaque marker
- The patient´s own assessment on which period they received Loperamide or Placebo
Construction of a stoma is a frequently used part of the surgical treatment of intestinal cancer and chronic intestinal inflammation. More than 60% of patients with an ileostomy develop dehydration and loss of salts and minerals, due to an excessive stoma output. The most common method used to reduce stoma output is Imodium® ( Loperamide ). The effect has never been studied extensively, probably because it is an over the counter medicine. The treatment is relatively expensive and also subject to side effects, even if they are mild. Therefore, the investigators found it relevant to perform a clinical study to determine the effect. The results will be important for future patient treatment.
The study is a clinical blinded randomized crossover study. The study includes three types of patients. Patients operated for rectal cancer or ulcerative colitis with a temporary or permanent ileostomy, and patients with short bowel syndrome with a permanent ileostomy. The first two types of patients will be recruited through two ways.
- During hospitalization in connection to their operation at The Department of Surgery, University Hospital Odense. The patients are offered inclusion into the study either before or after surgery depending upon the clinical situation. For those who consent and fulfills the inclusion criteria, the study starts up on 7th day after surgery.
- Through their regular controls in the stoma clinic.
Patients with short bowel syndrome are offered inclusion through their contact with The Department of Gastroenterology, University Hospital Odense, if they meet the criteria for inclusion.
Patients will undergo to periods during the study. They will be randomized to start with either Loperamide or Placebo. Each period consists of 3 days.
Day 1 - Uploading of the drug
Day 2 - Collecting of stoma output when necessary
Day 3 - Radiopaque marker and collection of stoma output every two hours
After 7 days without medicine intake the patient starts the second period with the opposite drug.
During day 2-3 the patient will register and weigh all food and fluid intake.
- Conditions
- Rectal Cancer, Ulcerative Colitis, Short Bowel Syndrome
- Being tested
- Loperamide, Placebo
- Medical subject headings
- Rectal Neoplasms, Colitis, Ulcerative, Short Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LoperamideDrug
Also called Imodium
12 mg Loperamide each day for three days
PlaceboDrug
6 tablets daily for three days
| Study group | Role | What they receive |
|---|---|---|
| Loperamide | Active comparator | Patients will take the drug for three days. Day 1 - uploading with the drug Day 2 - collecting output when necessary Day 3 - radiopaque marker and collection of output every two hours Receives: Drug: Loperamide |
| Placebo | Placebo comparator | Patients will take the drug for three days. Day 1 - uploading with the drug Day 2 - collecting output when necessary Day 3 - radiopaque marker and collection of output every two hours Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Output weight
Collection af output for two days to compare between the two periods
Measured: 2 days
Secondary outcomes (1)
Gastrointestinal transit time
Patients swallow a pill with radiopaque markers and collect stoma output every two hours
Measured: 10 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionAug 2015
- Study completionAug 2015
Why it stopped: Insuficcient recruiting
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Niels Qvist, Odense University Hospital
- Investigators
- Niels Qvist, MD, DMsc, Study director, Odense University Hospital, Department of Surgery A, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02266849
- Sponsor's protocol ID
- s-20140081
- Status last verified
- Oct 2016
- First submitted
- 8 Oct 2014
- Last updated
- 11 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kristensen K, Qvist N. The Acute Effect of Loperamide on Ileostomy Output: A Randomized, Double-Blinded, Placebo-Controlled, Crossover Study. Basic Clin Pharmacol Toxicol. 2017 Dec;121(6):493-498. doi: 10.1111/bcpt.12830. Epub 2017 Jul 10.
PubMed 28627732
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Loperamide vs. Placebo's Effect on Ileostomy Output: A Clinical Randomized Blinded Cross-over Study
- ClinicalTrials.gov ID
- NCT02266849
- Acronym / sponsor ID
- s-20140081
- Conditions
- Rectal Cancer, Ulcerative Colitis, Short Bowel Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insuficcient recruiting
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 17 Oct 2014 (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.
Clinical experience show limited effect of the drug Loperamide used to decrease output in stoma patients. Therefore the investigators see the need for a randomized blinded clinical trial to determine the effect of Loperamide opposite Placebo.
Loperamide will be evaluated in relation to the following parameters
- Change in ileostomy output in g/day in relation to oral intake
- Quantification of the change in intestinal transit time using a radiopaque marker
- The patient´s own assessment on which period they received Loperamide or Placebo
Detailed description
The aim of this study is to quantify the effect of Loperamide on ileostomy output in patients operated for rectal cancer, ulcerative colitis and in patients with short bowl syndrome. These patients are recruited through The Department of Surgery and The Department of Gastroenterology, University Hospital Odense. The effect of Loperamide will be evaluated against Placebo in relation to the following parameters:
- Change in ileostomy output in g/day in relation to oral intake
- Quantification of the change in intestinal transit time using a radiopaque marker
- The patient´s own assessment on which period they received Loperamide or Placebo
Construction of a stoma is a frequently used part of the surgical treatment of intestinal cancer and chronic intestinal inflammation. More than 60% of patients with an ileostomy develop dehydration and loss of salts and minerals, due to an excessive stoma output. The most common method used to reduce stoma output is Imodium® ( Loperamide ). The effect has never been studied extensively, probably because it is an over the counter medicine. The treatment is relatively expensive and also subject to side effects, even if they are mild. Therefore, the investigators found it relevant to perform a clinical study to determine the effect. The results will be important for future patient treatment.
The study is a clinical blinded randomized crossover study. The study includes three types of patients. Patients operated for rectal cancer or ulcerative colitis with a temporary or permanent ileostomy, and patients with short bowel syndrome with a permanent ileostomy. The first two types of patients will be recruited through two ways.
- During hospitalization in connection to their operation at The Department of Surgery, University Hospital Odense. The patients are offered inclusion into the study either before or after surgery depending upon the clinical situation. For those who consent and fulfills the inclusion criteria, the study starts up on 7th day after surgery.
- Through their regular controls in the stoma clinic.
Patients with short bowel syndrome are offered inclusion through their contact with The Department of Gastroenterology, University Hospital Odense, if they meet the criteria for inclusion.
Patients will undergo to periods during the study. They will be randomized to start with either Loperamide or Placebo. Each period consists of 3 days.
Day 1 - Uploading of the drug
Day 2 - Collecting of stoma output when necessary
Day 3 - Radiopaque marker and collection of stoma output every two hours
After 7 days without medicine intake the patient starts the second period with the opposite drug.
During day 2-3 the patient will register and weigh all food and fluid intake.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Loperamide | Active comparator | Drug: LoperamidePatients will take the drug for three days. Day 1 - uploading with the drug Day 2 - collecting output when necessary Day 3 - radiopaque marker and collection of output every two hours |
| Placebo | Placebo comparator | Drug: PlaceboPatients will take the drug for three days. Day 1 - uploading with the drug Day 2 - collecting output when necessary Day 3 - radiopaque marker and collection of output every two hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Operation for rectal cancer or ulcerative colitis an ileostomy (loop or end ileostomy within the last 7 days) OR
- ileostomy patient with contact to the stoma clinic OR
- Short bowel syndrome with a permanent ileostomy
- signed consent form
Key exclusion criteria (5 listed)
- Complications associated with surgery
- Non-radical surgery
- Chemotherapy
- Poor compliance
- Other serious illness
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 |
|---|---|---|
| LoperamideAlso: Imodium12 mg Loperamide each day for three days | Drug | Loperamide |
| Placebo6 tablets daily for three days | Drug | Placebo |
Primary outcome
Output weight
Time frame: 2 days
Collection af output for two days to compare between the two periods
1 secondary outcome
Gastrointestinal transit time
Time frame: 10 hours
Results and safety
The study was stopped early (reason given: Insuficcient recruiting). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2016.
- Derived from this study: PubMed 28627732Kristensen K, Qvist N. The Acute Effect of Loperamide on Ileostomy Output: A Randomized, Double-Blinded, Placebo-Controlled, Crossover Study. Basic Clin Pharmacol Toxicol. 2017 Dec;121(6):493-498. doi: 10.1111/bcpt.12830. Epub 2017 Jul 10.
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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.
Niels Qvist, MD, DMsc study director
Odense University Hospital, Department of Surgery A, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Loperamide in people with Rectal Cancer and Ulcerative Colitis, run by Odense University Hospital at 1 site in Denmark.
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 4 inclusion and 5 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 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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: Insuficcient recruiting). 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?
Output weight (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02266849, which also lists 1 linked publication.
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 Oct 2016.