Anal FissurePhase 1NCT02667535
PK, PD and Safety Comparative Trial of Isosorbide Mononitrate Gel in Healthy Participants and With Anal Fissure
A Phase 1 study testing Isosorbide Mononitrate in people with Anal Fissure, run by Biolab Sanus Farmaceutica.
Trial summary
This is a Phase I trial to evaluate Pharmacokinetics, Pharmacodynamics and Safety of Isosorbide Mononitrate gel for usage in participants with anal fissure and healthy volunteers. Three doses will be used in patients with anal fissure (0.5%, 1.0% or 2.0%) and healthy volunteers will receive 2.0% dose. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anal Fissure
- What is being tested?
- Isosorbide Mononitrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2017to Nov 2017
- Phase
- Phase 1
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female subjects aged ≥ 18 years-old;
- Body mass index (BMI) ≥ 19 Kg/m2 and ≤ 35 Kg/m2;
- For healthy volunteers: good health conditions or without significant diseases, according to best medical judgement, according to protocol requirements and study evaluations: medical history, blood pressure and heart rate measurements, physical examination, electrocardiogram (ECG) and screening laboratory tests;
- For participants with the condition under study: anal fissure;
- Ability to understand the nature and objectives of the trial, including risks and adverse events; willingness to cooperate with the researcher and proceed according to all study requirements, which shall be confirmed by Informed Consent Form signature.
Who cannot join
- Known hypersensitivity to the investigational products (naproxen or rebamipide) or chemically related compounds; history of serious adverse reactions or hypersensitivity to any drug;
- Chronic therapy with any drugs, except oral contraceptives and medication authorized by principal investigator (each case to be individually evaluated);
- History of hepatic, kidney, lungs, gastrointestinal, epileptic, hematologic or psychiatric disease; hypotension or hypertension, or any other co-morbidity that requires priority immediate treatment ot that, at principal investigator discretion, might interfere with study participation or expose study participant to risks other than predicted;
- Deviations on screening laboratory results that are considered as clinically relevant by the principal investigator;
- Smoking;
- History of drugs and alcohol addiction or excessive alcohol consumption (> 35 g/ day);
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- Use of regular medications within 2 weeks prior study enrollment or use of any medications within one week prior to study enrollment, except oral contraceptives or cases which, based on drug's or metabolite's half-life, complete elimination can be assumed;
- Treatment, within 6 months before the trial, with any drugs known to have a well established toxic potential to major organs;
- Participation in any other experimental research or administration of any experimental drug within six months before this trial;
- Donation or loss of 450 mL of blood (or more) within 3 months before the trial, or 4 donations within 12 months before the trial;
- Any condition, according to investigator's best judgement, that prevents the subject to participate in the trial;
- Pregnancy, labor or miscarriage with 12 weeks before admission predicted date.
About this study
Official title: Pharmacokinetics, Pharmacodynamics and Safety Comparative Trial of Isosorbide Mononitrate Gel in Participants With Anal Fissure and Healthy Volunteers.
This is a Phase I trial to evaluate Pharmacokinetics, Pharmacodynamics and Safety of Isosorbide Mononitrate gel for usage in participants with anal fissure and healthy volunteers. Three doses will be used in patients with anal fissure (0.5%, 1.0% or 2.0%) and healthy volunteers will receive 2.0% dose. All treatment will last 7 days.
Read the detailed description
This is a Phase I, open-label, parallel trial to evaluate Pharmacokinetics, Pharmacodynamics and Safety of Isosorbide Mononitrate gel for usage in participants with anal fissure and healthy volunteers.
Investigational product will be randomly assigned as follows:
- healthy volunteers will receive 2g (2.0%) of investigational product at a single dose, and will undergo a washout period of 7 days; subsequently, they will receive 2g of investigational product once daily, for 7 consecutive days;
- participants with anal fissure will receive 2g of investigational product, either at 0.5%, 1.0% or 2.0%, at a single dose, and will undergo a washout period of 7 days; subsequently, they will receive 2g of investigational product, either at 0.5%, 1.0% or 2.0%, once daily, for 7 consecutive days.
- Conditions
- Anal Fissure
- Being tested
- Isosorbide Mononitrate
- Medical subject headings
- Fissure in Ano
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isosorbide MononitrateDrug
Healthy volunteers will receive 2g (2.0%) of investigational product at a single dose, and will undergo a washout period of 7 days; subsequently, they will receive 2g of investigational product once daily, for 7 consecutive days.
Participants with anal fissure will receive 2g of investigational product, either at 0.5%, 1.0% or 2.0%, at a single dose, and will undergo a washout period of 7 days; subsequently, they will receive 2g of investigational product, either at 0.5%, 1.0% or 2.0%, once daily, for 7 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Isosorbide Mononitrate 2.0% healthy | Experimental | Isosorbide Mononitrate gel 2.0% - 2g Anorectal usage Once daily Healthy volunteers Receives: Drug: Isosorbide Mononitrate |
| Isosorbide Mononitrate 0.5% anal fissure | Experimental | Isosorbide Mononitrate gel 0.5% - 2g Anorectal usage Once daily Participants with anal fissure Receives: Drug: Isosorbide Mononitrate |
| Isosorbide Mononitrate 1.0% anal fissure | Experimental | Isosorbide Mononitrate gel 1.0% - 2g Anorectal usage Once daily Participants with anal fissure Receives: Drug: Isosorbide Mononitrate |
| Isosorbide Mononitrate 2.0% anal fissure | Experimental | Isosorbide Mononitrate gel 2.0% - 2g Anorectal usage Once daily Participants with anal fissure Receives: Drug: Isosorbide Mononitrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics, area under the curve time zero - last (AUC t0-last)
Measured: 7 days
Pharmacokinetics, area under the curve time zero - infinite (AUC t0-inf)
Measured: 7 days
Pharmacokinetics, constant of elimination (Ke)
Measured: 7 days
Pharmacokinetics, half-life (t1/2)
Measured: 7 days
Secondary outcomes (3)
Safety, by number of adverse events
Measured: 7 days
Safety, by blood pressure measurement
Measured: 7 days
Anorectal muscle contractility, by anorectal manometry
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2016 (estimated)
- Study startJul 2017 (estimated)
- Primary completionOct 2017 (estimated)
- Study completionNov 2017 (estimated)
Why it stopped: Study has been cancelled and it has not been initiated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal FissureStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biolab Sanus Farmaceutica
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilberto De Nucci, PhD, Principal investigator, Galeno Desenvolvimento de Pesquisas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02667535
- Sponsor's protocol ID
- GDN 001/16
- Status last verified
- Jul 2017
- First submitted
- 26 Jan 2016
- Last updated
- 17 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics, Pharmacodynamics and Safety Comparative Trial of Isosorbide Mononitrate Gel in Participants With Anal Fissure and Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT02667535
- Acronym / sponsor ID
- GDN 001/16
- Conditions
- Anal Fissure
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study has been cancelled and it has not been initiated.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Biolab Sanus FarmaceuticaIndustry (pharma, biotech, devices)
- Study start
- Jul 2017 (estimated)
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 29 Jan 2016 (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 a Phase I trial to evaluate Pharmacokinetics, Pharmacodynamics and Safety of Isosorbide Mononitrate gel for usage in participants with anal fissure and healthy volunteers. Three doses will be used in patients with anal fissure (0.5%, 1.0% or 2.0%) and healthy volunteers will receive 2.0% dose. All treatment will last 7 days.
Detailed description
This is a Phase I, open-label, parallel trial to evaluate Pharmacokinetics, Pharmacodynamics and Safety of Isosorbide Mononitrate gel for usage in participants with anal fissure and healthy volunteers.
Investigational product will be randomly assigned as follows:
- healthy volunteers will receive 2g (2.0%) of investigational product at a single dose, and will undergo a washout period of 7 days; subsequently, they will receive 2g of investigational product once daily, for 7 consecutive days;
- participants with anal fissure will receive 2g of investigational product, either at 0.5%, 1.0% or 2.0%, at a single dose, and will undergo a washout period of 7 days; subsequently, they will receive 2g of investigational product, either at 0.5%, 1.0% or 2.0%, once daily, for 7 consecutive days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Isosorbide Mononitrate 2.0% healthy | Experimental | Drug: Isosorbide MononitrateIsosorbide Mononitrate gel 2.0% - 2g Anorectal usage Once daily Healthy volunteers |
| Isosorbide Mononitrate 0.5% anal fissure | Experimental | Drug: Isosorbide MononitrateIsosorbide Mononitrate gel 0.5% - 2g Anorectal usage Once daily Participants with anal fissure |
| Isosorbide Mononitrate 1.0% anal fissure | Experimental | Drug: Isosorbide MononitrateIsosorbide Mononitrate gel 1.0% - 2g Anorectal usage Once daily Participants with anal fissure |
| Isosorbide Mononitrate 2.0% anal fissure | Experimental | Drug: Isosorbide MononitrateIsosorbide Mononitrate gel 2.0% - 2g Anorectal usage Once daily Participants with anal fissure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female subjects aged ≥ 18 years-old;
- Body mass index (BMI) ≥ 19 Kg/m2 and ≤ 35 Kg/m2;
- For healthy volunteers: good health conditions or without significant diseases, according to best medical judgement, according to protocol requirements and study evaluations: medical history, blood pressure and heart rate measurements, physical examination, electrocardiogram (ECG) and screening laboratory tests;
- For participants with the condition under study: anal fissure;
- Ability to understand the nature and objectives of the trial, including risks and adverse events; willingness to cooperate with the researcher and proceed according to all study requirements, which shall be confirmed by Informed Consent Form signature.
Key exclusion criteria (12 listed)
- Known hypersensitivity to the investigational products (naproxen or rebamipide) or chemically related compounds; history of serious adverse reactions or hypersensitivity to any drug;
- Chronic therapy with any drugs, except oral contraceptives and medication authorized by principal investigator (each case to be individually evaluated);
- History of hepatic, kidney, lungs, gastrointestinal, epileptic, hematologic or psychiatric disease; hypotension or hypertension, or any other co-morbidity that requires priority immediate treatment ot that, at principal investigator discretion, might interfere with study participation or expose study participant to risks other than predicted;
- Deviations on screening laboratory results that are considered as clinically relevant by the principal investigator;
- Smoking;
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 |
|---|---|---|
| Isosorbide MononitrateHealthy volunteers will receive 2g (2.0%) of investigational product at a single dose, and will undergo a washout period of 7 days; subsequently, they will receive 2g of investigational product once daily, for 7 consecutive days. Participants with anal fissure will receive 2g of investigational product, either at 0.5%, 1.0% or 2.0%, at a single dose, and will undergo a washout period of 7 days; subsequently, they will receive 2g of investigational product, either at 0.5%, 1.0% or 2.0%, once daily, for 7 consecutive days. | Drug | Isosorbide Mononitrate 0.5% anal fissure, Isosorbide Mononitrate 1.0% anal fissure, Isosorbide Mononitrate 2.0% anal fissure, Isosorbide Mononitrate 2.0% healthy |
Primary outcome
Pharmacokinetics, area under the curve time zero - last (AUC t0-last)
Time frame: 7 days
Pharmacokinetics, area under the curve time zero - infinite (AUC t0-inf)
Time frame: 7 days
Pharmacokinetics, constant of elimination (Ke)
Time frame: 7 days
Pharmacokinetics, half-life (t1/2)
Time frame: 7 days
3 secondary outcomes
Safety, by number of adverse events
Time frame: 7 days
Safety, by blood pressure measurement
Time frame: 7 days
Anorectal muscle contractility, by anorectal manometry
Time frame: 7 days
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 17 Jul 2017.
- Individual participant dataSharing planned: No
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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.
Gilberto De Nucci, PhD principal investigator
Galeno Desenvolvimento de Pesquisas
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Isosorbide Mononitrate in people with Anal Fissure, run by Biolab Sanus Farmaceutica.
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 5 inclusion and 12 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 17 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
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 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.
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?
Pharmacokinetics, area under the curve time zero - last (AUC t0-last) (time frame: 7 days). The study lists 4 primary outcomes in all. 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 17 Jul 2017.