Idiopathic Fecal IncontinencePhase 1/2NCT01421823
A Double Blinded Study to Examine the Effect of Alpha Agonist Ointment on Fecal Incontinence in Patients With Idiopathic Fecal Incontinence
A Phase 1/2 study testing alpha agonist ointment in people with Idiopathic Fecal Incontinence, run by RDD Pharma Ltd at 1 site in Israel.
Trial summary
The purpose of this study is to assess the effect and safety of alpha agonist ointment on fecal incontinence severity in patients with idiopathic fecal incontinence. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Idiopathic Fecal Incontinence
- What is being tested?
- alpha agonist ointment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2011to Apr 2012
- Phase
- Phase 1/2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consent.
- Male or female subjects 18 to 65 years of age.
- Fecal incontinence score over 8.
- The patient is able to understand the treatment and is willing to comply with the prescribed regimen.
Who cannot join
- Has a clinically significant history or presence of any of the following conditions:
- Known allergy to the API.
- Porphyria.
- 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;
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- Type 1 diabetes mellitus;
- Insulin treated type 2 diabetes mellitus.
- Renal insufficiency.
- Liver insufficiency.
- Malignant disease within 5 years of screening;
- Has hypertension (sitting blood pressure over 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 inhibitors.
- 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 ointment, as judged by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to assess the effect and safety of alpha agonist ointment on fecal incontinence severity in patients with idiopathic fecal incontinence.
Read the detailed description
This is a double blinded cross over study. Approximately 40 subjects will be participating in this 4 weeks study. A screening visit will be used to determine eligibility for the study. Patients found eligible will receive alpha agonist ointment or placebo ointment for 2 weeks. This will be followed by a second 2 weeks treatment cycle in which:
- patients previously treated with alpha agonist will be treated with placebo.
- patients previously treated with placebo will be treated with alpha agonist.
- Conditions
- Idiopathic Fecal Incontinence
- Being tested
- alpha agonist ointment, Placebo
- Keywords
- Fecal Incontinence, Alpha agonist
- Medical subject headings
- Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alpha agonist ointmentDrug
2 weeks local treatment with alpha agonist ointment
PlaceboDrug
2 weeks local treatment with placebo ointment
| Study group | Role | What they receive |
|---|---|---|
| alpha agonist ointment | Experimental | Not described Receives: Drug: alpha agonist ointment |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fecal Incontinence
number of unwanted/unexpected bowel movements in the time period after use of alpha agonist ointment
Measured: After 2 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionApr 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Fecal IncontinenceStudies 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 1/2
- 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)
- Responsible party
- Sponsor
- Investigators
- Yehiel Ziv, MD, Principal investigator, RDD Pharma Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01421823
- Sponsor's protocol ID
- RDD 111
- Status last verified
- Dec 2013
- First submitted
- 21 Aug 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 Alpha Agonist Ointment on Fecal Incontinence in Patients With Idiopathic Fecal Incontinence
- ClinicalTrials.gov ID
- NCT01421823
- Acronym / sponsor ID
- RDD 111
- Conditions
- Idiopathic Fecal Incontinence
- Keywords
- Fecal Incontinence, Alpha agonist
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- RDD Pharma LtdIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Apr 2012 (estimated)
- First posted
- 23 Aug 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.
The purpose of this study is to assess the effect and safety of alpha agonist ointment on fecal incontinence severity in patients with idiopathic fecal incontinence.
Detailed description
This is a double blinded cross over study. Approximately 40 subjects will be participating in this 4 weeks study. A screening visit will be used to determine eligibility for the study. Patients found eligible will receive alpha agonist ointment or placebo ointment for 2 weeks. This will be followed by a second 2 weeks treatment cycle in which:
- patients previously treated with alpha agonist will be treated with placebo.
- patients previously treated with placebo will be treated with alpha agonist.
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 |
|---|---|---|
| alpha agonist ointment | Experimental | Drug: alpha agonist ointment |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed written informed consent.
- Male or female subjects 18 to 65 years of age.
- Fecal incontinence score over 8.
- The patient is able to understand the treatment and is willing to comply with the prescribed regimen.
Key exclusion criteria (18 listed)
- Has a clinically significant history or presence of any of the following conditions:
- Known allergy to the API.
- Porphyria.
- Glaucoma.
- Pregnancy or lactation.
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 |
|---|---|---|
| alpha agonist ointment2 weeks local treatment with alpha agonist ointment | Drug | alpha agonist ointment |
| Placebo2 weeks local treatment with placebo ointment | Drug | Placebo |
Primary outcome
Fecal Incontinence
Time frame: After 2 weeks of treatment
number of unwanted/unexpected bowel movements in the time period after use of alpha agonist ointment
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.
Related trials for Idiopathic Fecal Incontinence
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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.
Yehiel Ziv, MD principal investigator
RDD Pharma Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing alpha agonist ointment in people with Idiopathic Fecal Incontinence, 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 4 inclusion and 18 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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: After 2 weeks of treatment). 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.