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PK, PD and Safety Comparative Trial of Isosorbide Mononitrate Gel in Healthy Participants and With Anal Fissure

Primary Purpose

Anal Fissure

Status

Withdrawn

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

Isosorbide Mononitrate

About this trial

This is an interventional treatment trial for Anal Fissure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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);
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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Isosorbide Mononitrate 2.0% healthy

Isosorbide Mononitrate 0.5% anal fissure

Isosorbide Mononitrate 1.0% anal fissure

Isosorbide Mononitrate 2.0% anal fissure

Arm Description

Isosorbide Mononitrate gel 2.0% - 2g Anorectal usage Once daily Healthy volunteers

Isosorbide Mononitrate gel 0.5% - 2g Anorectal usage Once daily Participants with anal fissure

Isosorbide Mononitrate gel 1.0% - 2g Anorectal usage Once daily Participants with anal fissure

Isosorbide Mononitrate gel 2.0% - 2g Anorectal usage Once daily Participants with anal fissure

Outcomes

Primary Outcome Measures

Pharmacokinetics, area under the curve time zero - last (AUC t0-last)

Pharmacokinetics, area under the curve time zero - infinite (AUC t0-inf)

Pharmacokinetics, constant of elimination (Ke)

Pharmacokinetics, half-life (t1/2)

Secondary Outcome Measures

Safety, by number of adverse events

Safety, by blood pressure measurement

Anorectal muscle contractility, by anorectal manometry

Full Information

NCT ID

NCT02667535

First Posted

January 26, 2016

Last Updated

July 13, 2017

Sponsor

Biolab Sanus Farmaceutica

1. Study Identification

Unique Protocol Identification Number

NCT02667535

Brief Title

PK, PD and Safety Comparative Trial of Isosorbide Mononitrate Gel in Healthy Participants and With Anal Fissure

Official Title

Pharmacokinetics, Pharmacodynamics and Safety Comparative Trial of Isosorbide Mononitrate Gel in Participants With Anal Fissure and Healthy Volunteers.

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Withdrawn

Why Stopped

Study has been cancelled and it has not been initiated.

Study Start Date

July 2017 (Anticipated)

Primary Completion Date

October 2017 (Anticipated)

Study Completion Date

November 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Biolab Sanus Farmaceutica

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anal Fissure

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Isosorbide Mononitrate 2.0% healthy

Arm Type

Experimental

Arm Description

Isosorbide Mononitrate gel 2.0% - 2g Anorectal usage Once daily Healthy volunteers

Arm Title

Isosorbide Mononitrate 0.5% anal fissure

Arm Type

Experimental

Arm Description

Isosorbide Mononitrate gel 0.5% - 2g Anorectal usage Once daily Participants with anal fissure

Arm Title

Isosorbide Mononitrate 1.0% anal fissure

Arm Type

Experimental

Arm Description

Isosorbide Mononitrate gel 1.0% - 2g Anorectal usage Once daily Participants with anal fissure

Arm Title

Isosorbide Mononitrate 2.0% anal fissure

Arm Type

Experimental

Arm Description

Isosorbide Mononitrate gel 2.0% - 2g Anorectal usage Once daily Participants with anal fissure

Intervention Type

Drug

Intervention Name(s)

Isosorbide Mononitrate

Intervention Description

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.

Primary Outcome Measure Information:

Title

Pharmacokinetics, area under the curve time zero - last (AUC t0-last)

Time Frame

7 days

Title

Pharmacokinetics, area under the curve time zero - infinite (AUC t0-inf)

Time Frame

7 days

Title

Pharmacokinetics, constant of elimination (Ke)

Time Frame

7 days

Title

Pharmacokinetics, half-life (t1/2)

Time Frame

7 days

Secondary Outcome Measure Information:

Title

Safety, by number of adverse events

Time Frame

7 days

Title

Safety, by blood pressure measurement

Time Frame

7 days

Title

Anorectal muscle contractility, by anorectal manometry

Time Frame

7 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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); 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gilberto De Nucci, PhD

Organizational Affiliation

Galeno Desenvolvimento de Pesquisas

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

PK, PD and Safety Comparative Trial of Isosorbide Mononitrate Gel in Healthy Participants and With Anal Fissure

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