HemorrhoidsPhase 2NCT01483833
Efficacy Study of Iferanserin to Treat Hemorrhoids
A Phase 2 study testing Iferanserin in people with Hemorrhoids, run by Ventrus Biosciences, Inc at 1 site in Germany.
Trial summary
To evaluate the safety and efficacy of topical 0.5% S-MPEC cream vs. placebo cream (applied twice daily for 14 days) in the treatment of Grade I - III hemorrhoids. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemorrhoids
- What is being tested?
- Iferanserin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 121 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2001to Aug 2002
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Diagnosis of grade I - III hemorrhoids with bleeding episodes of at least every other day during the last two weeks before enrollment in the study.
- Patients signing the Informed Consent form.
Who cannot join
- Patients with protruding or irreducible hemorrhoids (grade IV).
- Patients with anal fistulas, periproctitis or hemorrhagic diathesis
- Patients with current history of Type I or Type II diabetes mellitus.
- Patients with severe hepatic, renal or cardiovascular disorders.
- Patients with any type of infectious disease.
- Patients who have been involved with another experimental drug trial within the past 30 days.
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- Patients presently diagnosed with cancer.
- Patients who have known alcohol and drug abuse.
- Patients who require the use of suppositories.
- Patients with blood or urine laboratory values outside the normal limits or those with values considered abnormal in the opinion of the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Protocol for the Study of the Effects of S-MPEC (Iferanserin) in Patients With Hemorrhoids
To evaluate the safety and efficacy of topical 0.5% S-MPEC cream vs. placebo cream (applied twice daily for 14 days) in the treatment of Grade I - III hemorrhoids.
- Conditions
- Hemorrhoids
- Being tested
- Iferanserin, Placebo
- Medical subject headings
- Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IferanserinDrug
Also called VEN309
Iferanserin 0.5% ointment applied intra-anally twice daily for 14 days
PlaceboDrug
Placebo ointment applied intra-anally twice daily for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Iferanserin | Active comparator | Iferanserin administration intra-anally twice daily for 14 days Receives: Drug: Iferanserin |
| Placebo | Placebo comparator | Placebo administration intra-anally twice daily for 14 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of hemorrhoid bleeding
Change from pre-treatment in patient assessment of hemorrhoid bleeding (10-point scale: 1=Not at all, 10=Extremely) at the end of one- and two-weeks of treatment are the primary efficacy endpoints for the study.
Measured: Day 7 and 14
Secondary outcomes (1)
Assessment of bleeding, hemorrhoid size, other hemorrhoid symptoms, and physician evaluation of hemorrhoids.
Change from pre-treatment in patient assessment of bleeding on other treatment days, change from pre-treatment in hemorrhoid size, change from pre-treatment in patient assessment of other hemorrhoid symptoms/conditions on all treatment days, and physician evaluation of hemorrhoids at the end of treatment.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2011 (estimated)
- Study startSep 2001
- Primary completionAug 2002
- Study completionAug 2002
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 HemorrhoidsStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ventrus Biosciences, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01483833
- Sponsor's protocol ID
- VEN309-SMPEC-001
- Status last verified
- Nov 2011
- First submitted
- 22 Nov 2011
- Last updated
- 21 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Herold A, Dietrich J, Aitchison R. Intra-anal Iferanserin 10 mg BID for hemorrhoid disease: a prospective, randomized, double-blind, placebo-controlled trial. Clin Ther. 2012 Feb;34(2):329-40. doi: 10.1016/j.clinthera.2011.12.012. Epub 2012 Jan 11.
PubMed 22244049
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol for the Study of the Effects of S-MPEC (Iferanserin) in Patients With Hemorrhoids
- ClinicalTrials.gov ID
- NCT01483833
- Acronym / sponsor ID
- VEN309-SMPEC-001
- Conditions
- Hemorrhoids
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Ventrus Biosciences, IncIndustry (pharma, biotech, devices)
- Study start
- Sep 2001
- Primary completion
- Aug 2002 (actual)
- Study completion
- Aug 2002 (actual)
- First posted
- 1 Dec 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.
To evaluate the safety and efficacy of topical 0.5% S-MPEC cream vs. placebo cream (applied twice daily for 14 days) in the treatment of Grade I - III hemorrhoids.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iferanserin | Active comparator | Drug: IferanserinIferanserin administration intra-anally twice daily for 14 days |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo administration intra-anally twice daily for 14 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years or older
- Diagnosis of grade I - III hemorrhoids with bleeding episodes of at least every other day during the last two weeks before enrollment in the study.
- Patients signing the Informed Consent form.
Key exclusion criteria (10 listed)
- Patients with protruding or irreducible hemorrhoids (grade IV).
- Patients with anal fistulas, periproctitis or hemorrhagic diathesis
- Patients with current history of Type I or Type II diabetes mellitus.
- Patients with severe hepatic, renal or cardiovascular disorders.
- Patients with any type of infectious disease.
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 |
|---|---|---|
| IferanserinAlso: VEN309Iferanserin 0.5% ointment applied intra-anally twice daily for 14 days | Drug | Iferanserin |
| PlaceboPlacebo ointment applied intra-anally twice daily for 14 days | Drug | Placebo |
Primary outcome
Assessment of hemorrhoid bleeding
Time frame: Day 7 and 14
Change from pre-treatment in patient assessment of hemorrhoid bleeding (10-point scale: 1=Not at all, 10=Extremely) at the end of one- and two-weeks of treatment are the primary efficacy endpoints for the study.
1 secondary outcome
Assessment of bleeding, hemorrhoid size, other hemorrhoid symptoms, and physician evaluation of hemorrhoids.
Time frame: 14 days
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 21 Aug 2013.
- Derived from this study: PubMed 22244049Herold A, Dietrich J, Aitchison R. Intra-anal Iferanserin 10 mg BID for hemorrhoid disease: a prospective, randomized, double-blind, placebo-controlled trial. Clin Ther. 2012 Feb;34(2):329-40. doi: 10.1016/j.clinthera.2011.12.012. Epub 2012 Jan 11.
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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 2 study testing Iferanserin in people with Hemorrhoids, run by Ventrus Biosciences, Inc at 1 site in Germany.
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 3 inclusion and 10 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 21 Aug 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 Germany. 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 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?
Assessment of hemorrhoid bleeding (time frame: Day 7 and 14). 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 NCT01483833, 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 21 Aug 2013.