IncontinencePhase 1/2NCT00972998
Study to Examine the Effect of Coated Phenylephrine Suppositories on Anal Pressure in Healthy Subjects
A Phase 1/2 study testing Phenyephrine in people with Incontinence, run by RDD Pharma Ltd at 1 site in Israel.
Trial summary
This is an open label, dose-finding study. Approximately 8 healthy subjects will be participating in this study. A screening will be used to determine subject suitability for inclusion in the trial. Subjects who meet all inclusion criteria and none of the exclusion criteria will enter a one day treatment period. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Incontinence
- What is being tested?
- Phenyephrine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2009to Dec 2009
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed written informed consent.
- Male or female subjects 18 to 55 years of age.
Who cannot join
- Active or chronic disease.
- In need of chronic use of medication, with the exception of birth control medications.
- Currently uses medication for acute illness.
- Has used, in the last four weeks, drugs that may affect blood coagulation, such as Aspirin, Warfarin, Sintrom, Enoxaparin, Nadroparin, Heparin, Clopidogrel, Ticlopidine.
- Has upon physical examination a rectal deformation or signs of rectal disease such as fissure, bleeding hemorrhoids, fistula., infection or space occupying lesion.
- Receipt of any investigational treatment (drug or device) within 90 days prior to screening.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Dept of Gastroeneterology, Asaf Harofe Medical Center
Zrifin, 70300
About this study
Official title: An Open Label Study to Examine the Effect of Coated Phenylephrine Suppositories on Anal Pressure in Healthy Subjects
This is an open label, dose-finding study. Approximately 8 healthy subjects will be participating in this study.
A screening will be used to determine subject suitability for inclusion in the trial. Subjects who meet all inclusion criteria and none of the exclusion criteria will enter a one day treatment period. During this period, 4 anal manometric studies will take place. Study medication (Coated Phenylephrine suppositories at various doses) will be administered at pre-determined intervals.
Read the detailed description
This is an open label, dose-finding study. Approximately 8 healthy subjects will be participating in this study. A screening will be used to determine subject suitability for inclusion in the trial. Within one week after the screening visit, subjects who meet all inclusion criteria and none of the exclusion criteria will enter a one day treatment period. During this period, 4 anal manometric studies will take place. Study medication (Coated Phenylephrine suppositories at various doses) will be administered at pre-determined intervals. During the study, blood samples will be obtained for plasma Phenylephrine analysis.After determining baseline resting anal pressure with a manometric test, coated Suppositories will be administered intra rectally. Subjects will take rectally a total of 1 Coated Suppository per study. 60, 120 and 240 minutes after the coated suppository insertion amnometric studies will be performed: The first 2 subjects in the study will receive 40 mg phenyephrine coated suppositories. If significant (> 15%) increase in the resting anal pressure will occur with this dose, the rest of the study subjects will receive the same dose. If the raise in the resting anal pressure will not be significant AND no adverse events was observed, than the following subjects will receive 80 mg phenylehprine coated suppositories.
- Conditions
- Incontinence
- Being tested
- Phenyephrine
- Keywords
- anal sphincter pressure, phenyephrine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhenyephrineDrug
Phenyephrine coated suppositories
| Study group | Role | What they receive |
|---|---|---|
| Healthy individuals | Experimental | Not described Receives: Drug: Phenyephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy parameter is change in Resting Anal Pressure from baseline.
Measured: 8 hours
Secondary outcomes (3)
The ratio of change in anal pressure to plasma Phenylephrine level.
Measured: 8 hours
The ratio of change in anal pressure to change in blood pressure.
Measured: 8 hours
The ratio of change in anal pressure to change in heart rate.
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- RDD Pharma Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Shlomo Shapiro, MD, Principal investigator, Dept of gastroeneterology, asaf harofe medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00972998
- Sponsor's protocol ID
- RDD 105
- Status last verified
- Dec 2009
- First submitted
- 17 Aug 2009
- Last updated
- 29 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Study to Examine the Effect of Coated Phenylephrine Suppositories on Anal Pressure in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00972998
- Acronym / sponsor ID
- RDD 105
- Conditions
- Incontinence
- Keywords
- anal sphincter pressure, phenyephrine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- RDD Pharma LtdIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 9 Sep 2009 (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 open label, dose-finding study. Approximately 8 healthy subjects will be participating in this study.
A screening will be used to determine subject suitability for inclusion in the trial. Subjects who meet all inclusion criteria and none of the exclusion criteria will enter a one day treatment period. During this period, 4 anal manometric studies will take place. Study medication (Coated Phenylephrine suppositories at various doses) will be administered at pre-determined intervals.
Detailed description
This is an open label, dose-finding study. Approximately 8 healthy subjects will be participating in this study. A screening will be used to determine subject suitability for inclusion in the trial. Within one week after the screening visit, subjects who meet all inclusion criteria and none of the exclusion criteria will enter a one day treatment period. During this period, 4 anal manometric studies will take place. Study medication (Coated Phenylephrine suppositories at various doses) will be administered at pre-determined intervals. During the study, blood samples will be obtained for plasma Phenylephrine analysis.After determining baseline resting anal pressure with a manometric test, coated Suppositories will be administered intra rectally. Subjects will take rectally a total of 1 Coated Suppository per study. 60, 120 and 240 minutes after the coated suppository insertion amnometric studies will be performed: The first 2 subjects in the study will receive 40 mg phenyephrine coated suppositories. If significant (> 15%) increase in the resting anal pressure will occur with this dose, the rest of the study subjects will receive the same dose. If the raise in the resting anal pressure will not be significant AND no adverse events was observed, than the following subjects will receive 80 mg phenylehprine coated suppositories.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy individuals | Experimental | Drug: Phenyephrine |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Signed written informed consent.
- Male or female subjects 18 to 55 years of age.
Key exclusion criteria (6 listed)
- Active or chronic disease.
- In need of chronic use of medication, with the exception of birth control medications.
- Currently uses medication for acute illness.
- Has used, in the last four weeks, drugs that may affect blood coagulation, such as Aspirin, Warfarin, Sintrom, Enoxaparin, Nadroparin, Heparin, Clopidogrel, Ticlopidine.
- Has upon physical examination a rectal deformation or signs of rectal disease such as fissure, bleeding hemorrhoids, fistula., infection or space occupying lesion.
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 |
|---|---|---|
| PhenyephrinePhenyephrine coated suppositories | Drug | Healthy individuals |
Primary outcome
The primary efficacy parameter is change in Resting Anal Pressure from baseline.
Time frame: 8 hours
3 secondary outcomes
The ratio of change in anal pressure to plasma Phenylephrine level.
Time frame: 8 hours
The ratio of change in anal pressure to change in blood pressure.
Time frame: 8 hours
The ratio of change in anal pressure to change in heart rate.
Time frame: 8 hours
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 29 Dec 2009.
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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.
Shlomo Shapiro, MD principal investigator
Dept of gastroeneterology, asaf harofe medical center
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 Phenyephrine in people with 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 2 inclusion and 6 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 29 Dec 2009. 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. 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?
The primary efficacy parameter is change in Resting Anal Pressure from baseline. (time frame: 8 hours). 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 29 Dec 2009; AzTrials last refreshed its copy on 6 Nov 2026.