Fecal IncontinenecePhase 2NCT01297608
A Double Blinded Study to Examine the Effect of Coated Suppositories on Fecal Incontinence in Patients With Spinal Cord Injury
A Phase 2 study testing caoted suppository and coated suppository in people with Fecal Incontinenece, run by RDD Pharma Ltd at 1 site in Israel.
Trial summary
This is a double blinded cross over study. Approximately 20 spinal cord injury patients will be participating in this 4 weeks study.The primary outcome is difference in fecal incontinence as recorded in diaries, between the treatment period and the treatment period. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Fecal Incontinenece
- What is being tested?
- caoted suppository and coated suppository
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2011to Sep 2011
- Phase
- Phase 2
- 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Signed written informed consent; Male or female subjects 18 to 55 years of age; Spinal cord lesion/disease/injury at any level at least 3 months from injury. FISI (Fecal Incontinence Severity Index) > 8 units. The patient is able to understand the treatment and is willing to comply with the prescribed regimen
Who cannot join
- Known allergy to experimental drug..
- Porphiria.
- Glaucoma.
- Pregnancy or lactation.
- Active or past history of cardiovascular or cerebrovascular disease including unstable angina, myocardial infarction, transient ischemic attacks/stroke, clinically significant arrhythmia, congestive heart failure, or cardiac valve abnormalities;
- Type 1 diabetes mellitus;
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- Insulin treated type 2 diabetes mellitus.
- Renal insufficiency.
- Liver insufficiency.
- Malignant disease within 5 years of screening;
- Has hypertension (sitting blood pressure > 140/90 mmHg at screening)
- History of rectal surgery.
- History of HIV, hepatitis B, hepatitis.
- Has used, in the last four weeks, drugs that may affect blood coagulation, such as Aspirin (at a dose above 250 mg/day), Warfarin, Sintrom, Enoxaparin, Nadroparin, Heparin, Clopidogrel, Ticlopidine.
- Use of tricyclic or monoamine-oxidase inhibors.
- Has upon physical examination a rectal deformation or signs of rectal disease such as fissure, bleeding hemorrhoids, fistula, infection or space occupying lesion.
- Unable to understand the use instruction for the coated suppository, as judged by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
This is a double blinded cross over study. Approximately 20 spinal cord injury patients will be participating in this 4 weeks study.The primary outcome is difference in fecal incontinence as recorded in diaries, between the treatment period and the treatment period.
- Conditions
- Fecal Incontinenece
- Being tested
- caoted suppository, coated suppository
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
caoted suppositoryDrug
coated suppository with active drug
coated suppositoryDrug
coated suppository with placebo
| Study group | Role | What they receive |
|---|---|---|
| treatment | Experimental | Not described Receives: Drug: caoted suppository; Drug: coated suppository |
| placebo | Placebo comparator | Not described Receives: Drug: coated suppository |
What is being measured
The primary outcome is the main question the study is designed to answer.
fecal incontinence
Measured: 2 weeks
Secondary outcomes (1)
quality of life
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2011 (estimated)
- Study startApr 2011
- Primary completionAug 2011 (estimated)
- Study completionSep 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fecal IncontineneceStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- RDD Pharma Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01297608
- Sponsor's protocol ID
- RDD 106
- Status last verified
- Dec 2013
- First submitted
- 15 Feb 2011
- Last updated
- 12 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blinded Study to Examine the Effect of Coated Suppositories on Fecal Incontinence in Patients With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT01297608
- Acronym / sponsor ID
- RDD 106
- Conditions
- Fecal Incontinenece
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- RDD Pharma LtdIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Aug 2011 (estimated)
- Study completion
- Sep 2011 (estimated)
- First posted
- 17 Feb 2011 (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.
This is a double blinded cross over study. Approximately 20 spinal cord injury patients will be participating in this 4 weeks study.The primary outcome is difference in fecal incontinence as recorded in diaries, between the treatment period and the treatment period.
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 |
|---|---|---|
| treatment | Experimental | Drug: caoted suppository, Drug: coated suppository |
| placebo | Placebo comparator | Drug: coated suppository |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Signed written informed consent; Male or female subjects 18 to 55 years of age; Spinal cord lesion/disease/injury at any level at least 3 months from injury. FISI (Fecal Incontinence Severity Index) > 8 units. The patient is able to understand the treatment and is willing to comply with the prescribed regimen
Key exclusion criteria (17 listed)
- Known allergy to experimental drug..
- Porphiria.
- Glaucoma.
- Pregnancy or lactation.
- Active or past history of cardiovascular or cerebrovascular disease including unstable angina, myocardial infarction, transient ischemic attacks/stroke, clinically significant arrhythmia, congestive heart failure, or cardiac valve abnormalities;
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 |
|---|---|---|
| caoted suppositorycoated suppository with active drug | Drug | treatment |
| coated suppositorycoated suppository with placebo | Drug | placebo, treatment |
Primary outcome
fecal incontinence
Time frame: 2 weeks
1 secondary outcome
quality of life
Time frame: 2 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2013.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing caoted suppository and coated suppository in people with Fecal Incontinenece, run by RDD Pharma Ltd at 1 site in Israel.
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 1 inclusion and 17 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: withdrawn, as of the sponsor's last update on 12 Dec 2013. 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 Israel. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 withdrawn before enrolling participants, so there are no results.
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?
fecal incontinence (time frame: 2 weeks). 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 12 Dec 2013.