Proctological DisordersNCT03833076
A New Class IIb MD in Proctological Disorders
A study testing Medical device Procto in people with Proctological Disorders, run by Nathura S.p.A at 1 site in Italy.
Trial summary
The aim of this study is primarily to investigate the performance of a new medical device not yet CE marked in comparison with placebo, in relieving proctological symptomatology in adult patients reporting symptoms of hemorrhoids (grade 1-3), anal fissures and proctitides. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Proctological Disorders
- What is being tested?
- Medical device Procto
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 118 participants
- Where
- 1 siteItaly
- Study dates
- 22 Aug 2019to 27 Nov 2020
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of both sexes aged between 18 and 75 years.
- Patients reporting symptoms of haemorrhoids (grade 1-3*), anal fissures and proctitides or already diagnosed with haemorrhoids (grade 1-3), anal fissures and proctitides; diagnosis confirmed by proctological examination at Screening Visit.
- Grade 1 - Haemorrhoid protrudes into the anal canal but does not prolapse outside the anus.
- Grade 2 - Haemorrhoid protrudes through the anus during straining or evacuation but returns spontaneously.
- Grade 3 - Haemorrhoid protrudes through the anus during straining or evacuation but needs to be manually returned to position.
- Grade 4 - Haemorrhoid remains prolapsed outside of the anus.
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- Patients agreeing not to use any other systemic or topic medicinal / product to treat haemorrhoids, anal fissures and proctitides during the study and not to modify their personal hygiene products.
- Female patients of childbearing potential following a reliable contraceptive method (according to Investigator's opinion).
- Willingness to participate in the study and to sign an informed consent form.
Who cannot join
- Patients presenting infective anal or rectal pathologies (in particular bacterial infections associated with proctitides or proctitides caused by viral infections).
- Patients presenting complicated haemorrhoids.
- Patients with Crohn's disease or malignancy.
- Patients presenting undiagnosed abnormal rectal bleeding.
- Patients with known or suspected rectal hypersensitivity.
- Patients presenting coagulation disorders or on anticoagulant drug therapy (except clopidogrel or acetylsalicylic acid).
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- Patients in treatment with topic or systemic medications / products to treat haemorrhoids, fissures and proctitides, currently or in the 2 weeks prior to Screening Visit.
- Patients using laxatives or stool softener currently or in the 2 weeks prior to Screening Visit.
- Patients pregnant or breastfeeding.
- Patients reporting past or present narcotic addiction or alcoholism.
- Patients that participated in any other clinical trial during the last month or participating in any clinical trial while participating in this trial.
- Patients reporting allergy or intolerance to any component of test product, placebo or rescue product.
- Patients who in the opinion of the principal Investigator are at risk of non-compliance to the study procedures or who are otherwise not appropriate to include in this clinical trial.
- Patients presenting contraindications to Proktis-M (rescue product), according to concerning leaflet.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Performance and Safety of a New Medical Device Class IIb Not Yet CE Marked in Proctological Disorders: a Randomised, Double-blind, Parallel-groups, Multicentric, Placebo-controlled, Prospective Clinical Study.
The aim of this study is primarily to investigate the performance of a new medical device not yet CE marked in comparison with placebo, in relieving proctological symptomatology in adult patients reporting symptoms of hemorrhoids (grade 1-3), anal fissures and proctitides.
- Conditions
- Proctological Disorders
- Being tested
- Medical device Procto, Matching placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical device ProctoDevice
Medical device Procto presents itself as a translucent green gel with a typical smell.
Matching placeboDevice
IP placebo presents itself as a translucent green gel with a typical smell.
| Study group | Role | What they receive |
|---|---|---|
| GROUP A: Medical Device Procto | Experimental | Medical device Procto presents itself as a translucent green gel with a typical smell; it is intended for topical use.
Posology: external or internal use by means of the provided rectal applicator and following the instructions on the package insert. It can be applied when needed, after intimate cleansing, at any time. Receives: Device: Medical device Procto |
| GROUP B: Matching placebo | Placebo comparator | Investigational Product (IP) placebo presents itself as a translucent green gel with a typical smell; it is intended for topical use.
Posology: external or internal use by means of the provided rectal applicator and following the instructions on the package insert. It can be applied when needed, after intimate cleansing, at any time. Receives: Device: Matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of symptoms according to the Proctological Symptom Scale (PSS)
Assessment of symptoms according to the Proctological Symptom Scale - PSS (according to 100 mm Visual Analogue Scales; from "no symptoms" to "overwhelming symptoms); comparison between groups, from Day 0 to Day 14
Measured: from Day 0 to Day 14
Secondary outcomes (7)
Investigator's assessment of signs
Investigator's assessment of signs: anal pain, inflammation and visible bleeding, categorized as none, mild, moderate, or severe (corresponding to a score of 0, 1, 2 or 3, respectively); comparison between groups, from Day 0 to Day 14.
Measured: from Day 0 to Day 14
Assessments done by Investigator of overall improvement
Assessments done by Investigator of overall improvement by means of Global Assessment of Improvement (GAI - according to a 7-grade scoring system, 0-6); comparison between groups, at Day 14.
Measured: from Day 0 to Day 14
Self-assessment of subjective symptoms
Self-assessment of subjective symptoms (anal pain, pain or discomfort during evacuation, itching, irritation or inflammation, bleeding) by means of 100 mm Visual Analogue Scales (from "no symptoms" to "overwhelming symptoms"); comparison between groups, from Day 0 to Day 14.
Measured: from Day 0 to Day 14
Self-assessment of overall treatment
Self-assessment of overall treatment by means of Overall Treatment Evaluation (OTE - according to a 15-point scale; from -7 to -1 = worse; 0 = no change; from +1 to +7 = better); comparison between groups, at Day 14.
Measured: from Day 0 to Day 14
Patient willingness
Patient willingness to use the product in the future, assessed on 1 - 4 points scale (strongly disagree=1, disagree=2, agree=3, strongly agree=4); comparison between groups, at Day 14.
Measured: from Day 0 to Day 14
Assessment of rescue product
Assessment of rescue product use (starting date the rescue product was used); comparison among groups, at Day 14.
Measured: from Day 0 to Day 14
Assessment of rescue product
Assessment of rescue product use (number of times the rescue product was used); comparison among groups, at Day 14.
Measured: from Day 0 to Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2019
- Study start22 Aug 2019
- Primary completion27 Nov 2020
- Study completion27 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proctological DisordersStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- a randomised, double-blind, parallel-groups, multicentric, placebo-controlled, prospective clinical study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nathura S.p.A
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Evidilya S.r.l.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03833076
- Sponsor's protocol ID
- ProctoMD01
- Status last verified
- Dec 2020
- First submitted
- 1 Feb 2019
- Last updated
- 23 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Performance and Safety of a New Medical Device Class IIb Not Yet CE Marked in Proctological Disorders: a Randomised, Double-blind, Parallel-groups, Multicentric, Placebo-controlled, Prospective Clinical Study.
- ClinicalTrials.gov ID
- NCT03833076
- Acronym / sponsor ID
- ProctoMD01
- Conditions
- Proctological Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Nathura S.p.AIndustry (pharma, biotech, devices)
- Collaborators
- Evidilya S.r.l.
- Study start
- 22 Aug 2019 (actual)
- Primary completion
- 27 Nov 2020 (actual)
- Study completion
- 27 Nov 2020 (actual)
- First posted
- 6 Feb 2019 (actual)
- 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 aim of this study is primarily to investigate the performance of a new medical device not yet CE marked in comparison with placebo, in relieving proctological symptomatology in adult patients reporting symptoms of hemorrhoids (grade 1-3), anal fissures and proctitides.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- a randomised, double-blind, parallel-groups, multicentric, placebo-controlled, prospective clinical study
| Arm | Type | Receives |
|---|---|---|
| GROUP A: Medical Device Procto | Experimental | Device: Medical device ProctoMedical device Procto presents itself as a translucent green gel with a typical smell; it is intended for topical use. Posology: external or internal use by means of the provided rectal applicator and following the instructions on the package insert. It can be applied when needed, after intimate cleansing, at any time. |
| GROUP B: Matching placebo | Placebo comparator | Device: Matching placeboInvestigational Product (IP) placebo presents itself as a translucent green gel with a typical smell; it is intended for topical use. Posology: external or internal use by means of the provided rectal applicator and following the instructions on the package insert. It can be applied when needed, after intimate cleansing, at any time. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients of both sexes aged between 18 and 75 years.
- Patients reporting symptoms of haemorrhoids (grade 1-3*), anal fissures and proctitides or already diagnosed with haemorrhoids (grade 1-3), anal fissures and proctitides; diagnosis confirmed by proctological examination at Screening Visit.
- Grade 1 - Haemorrhoid protrudes into the anal canal but does not prolapse outside the anus.
- Grade 2 - Haemorrhoid protrudes through the anus during straining or evacuation but returns spontaneously.
- Grade 3 - Haemorrhoid protrudes through the anus during straining or evacuation but needs to be manually returned to position.
Key exclusion criteria (14 listed)
- Patients presenting infective anal or rectal pathologies (in particular bacterial infections associated with proctitides or proctitides caused by viral infections).
- Patients presenting complicated haemorrhoids.
- Patients with Crohn's disease or malignancy.
- Patients presenting undiagnosed abnormal rectal bleeding.
- Patients with known or suspected rectal hypersensitivity.
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 |
|---|---|---|
| Medical device ProctoMedical device Procto presents itself as a translucent green gel with a typical smell. | Device | GROUP A: Medical Device Procto |
| Matching placeboIP placebo presents itself as a translucent green gel with a typical smell. | Device | GROUP B: Matching placebo |
Primary outcome
Assessment of symptoms according to the Proctological Symptom Scale (PSS)
Time frame: from Day 0 to Day 14
Assessment of symptoms according to the Proctological Symptom Scale - PSS (according to 100 mm Visual Analogue Scales; from "no symptoms" to "overwhelming symptoms); comparison between groups, from Day 0 to Day 14
7 secondary outcomes
Investigator's assessment of signs
Time frame: from Day 0 to Day 14
Assessments done by Investigator of overall improvement
Time frame: from Day 0 to Day 14
Self-assessment of subjective symptoms
Time frame: from Day 0 to Day 14
Self-assessment of overall treatment
Time frame: from Day 0 to Day 14
Patient willingness
Time frame: from Day 0 to Day 14
Assessment of rescue product
Time frame: from Day 0 to Day 14
Assessment of rescue product
Time frame: from Day 0 to Day 14
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 23 Dec 2020.
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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 study testing Medical device Procto in people with Proctological Disorders, run by Nathura S.p.A at 1 site in Italy.
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 9 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 23 Dec 2020. 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 Italy. 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.
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 symptoms according to the Proctological Symptom Scale (PSS) (time frame: from Day 0 to Day 14). 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 23 Dec 2020.