Fecal IncontinencePhase 1/2NCT02299557
The Effect of Oxymetazoline Gel on Anal Pressure and Incontinence in Spinal Cord Injury Patients
A Phase 1/2 study testing Oxymetazoline gel in people with Fecal Incontinence and Spinal Cord Injury, run by RDD Pharma Ltd at 1 site in Hungary.
Trial summary
This is an double blinded, cross-over study to determine the effect of Oxymetazoline gel on anal resting pressure and fecal incontinence in patients with spinal cord injury. Approximately 17 subjects are expected to complete this 10 weeks study that will include two treatment periods of 4 weeks each, and one 2 weeks… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Fecal Incontinence, Spinal Cord Injury
- What is being tested?
- Oxymetazoline gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteHungary
- Study dates
- Nov 2014to Jul 2015
- 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 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 Injury that occurred at least 3 months from randomization day and less than 3 years from randomization day.
- At least 4 unwanted/unexpected incontinent events/week
Who cannot join
- Known allergy to Oxymetazoline or silicone.
- Pregnancy or lactation.
- Active 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;
- Insulin treated type 2 diabetes mellitus;
- Renal insufficiency.
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- Liver insufficiency.
- Malignant disease within 5 years of screening;
- History of rectal surgery.
- History of HIV, hepatitis B, hepatitis C.
- Has upon physical examination a rectal deformation or signs of rectal disease such as fissure, bleeding hemorrhoids, fistula, infection or space occupying lesion.
- Has used, in the last 1 week, drugs that may affect blood coagulation, such as Aspirin (at a dose above 500 mg/day), Warfarin, Sintrom, Enoxaparin, Nadroparin, Heparin, Clopidogrel, Ticlopidine.
- Hypertension (blood pressure over 150/105 mm Hg in screening visit)
- Unable to understand the use instruction, as judged by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double Blind Study to Examine the Effect of Oxymetazoline Gel on Anal Pressure and Incontinence in Spinal Cord Injury Patients
This is an double blinded, cross-over study to determine the effect of Oxymetazoline gel on anal resting pressure and fecal incontinence in patients with spinal cord injury. Approximately 17 subjects are expected to complete this 10 weeks study that will include two treatment periods of 4 weeks each, and one 2 weeks wash out period.
- Conditions
- Fecal Incontinence, Spinal Cord Injury
- Being tested
- Oxymetazoline gel, Placebo gel
- Medical subject headings
- Fecal Incontinence, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxymetazoline gelDrug
Oxymetazoline gel applied intra-anally once daily
Placebo gelDrug
Placebo gel applied intra-anally once daily
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Intra-anal Oxymetazoline gel once daily Receives: Drug: Oxymetazoline gel |
| Placebo | Placebo comparator | Intra-anal Placebo gel once daily Receives: Drug: Placebo gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
To examine the effect of Oxymetazoline gel on fecal incontinence episodes in the 8 hours following application.
Measured: 4 weeks
Secondary outcomes (2)
Pharmacokinetics (area under the curve [AUC]), peak concentration and half life time (T 1/2) of Oxymetazoline;
Measured: 4 weeks
Number of participants with adverse events
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionJun 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- RDD Pharma Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02299557
- Sponsor's protocol ID
- RDD 116
- Status last verified
- Jul 2015
- First submitted
- 17 Nov 2014
- Last updated
- 28 Jul 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind Study to Examine the Effect of Oxymetazoline Gel on Anal Pressure and Incontinence in Spinal Cord Injury Patients
- ClinicalTrials.gov ID
- NCT02299557
- Acronym / sponsor ID
- RDD 116
- Conditions
- Fecal Incontinence, Spinal Cord Injury
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- RDD Pharma LtdIndustry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 24 Nov 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.
This is an double blinded, cross-over study to determine the effect of Oxymetazoline gel on anal resting pressure and fecal incontinence in patients with spinal cord injury. Approximately 17 subjects are expected to complete this 10 weeks study that will include two treatment periods of 4 weeks each, and one 2 weeks wash out 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: Oxymetazoline gelIntra-anal Oxymetazoline gel once daily |
| Placebo | Placebo comparator | Drug: Placebo gelIntra-anal Placebo gel once daily |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Signed written informed consent.
- Male or female subjects 18 to 55 years of age;
- Spinal Cord Injury that occurred at least 3 months from randomization day and less than 3 years from randomization day.
- At least 4 unwanted/unexpected incontinent events/week
Key exclusion criteria (14 listed)
- Known allergy to Oxymetazoline or silicone.
- Pregnancy or lactation.
- Active 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;
- Insulin treated type 2 diabetes mellitus;
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 |
|---|---|---|
| Oxymetazoline gelOxymetazoline gel applied intra-anally once daily | Drug | Treatment |
| Placebo gelPlacebo gel applied intra-anally once daily | Drug | Placebo |
Primary outcome
To examine the effect of Oxymetazoline gel on fecal incontinence episodes in the 8 hours following application.
Time frame: 4 weeks
2 secondary outcomes
Pharmacokinetics (area under the curve [AUC]), peak concentration and half life time (T 1/2) of Oxymetazoline;
Time frame: 4 weeks
Number of participants with adverse events
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2015.
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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.
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 1/2 study testing Oxymetazoline gel in people with Fecal Incontinence and Spinal Cord Injury, run by RDD Pharma Ltd at 1 site in Hungary.
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 14 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: finished, as of the sponsor's last update on 28 Jul 2015. 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 Hungary. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To examine the effect of Oxymetazoline gel on fecal incontinence episodes in the 8 hours following application. (time frame: 4 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 28 Jul 2015.