Patients in this arm will receive topical treatment with Minoxidil forte 5% gel three times per days for 4 weeks

Patients in this arm will receive topical treatment with glyceryl trinitrate 0.2% cream three times per days for 4 weeks

Anal Fissure

application of minoxidil forte 5% gel three time per day on the anus for four weeks

Minoxidil

application of glyceryl trinitrate 0.2% cream three time per day on the anus for four weeks

Glyceryl trinitrate

Mansoura university hospital

Topical Minoxidil Versus Topical Glyceryl Trinitrate in Treatment of Chronic Anal Fissure

Topical 5% Minoxidil Versus 0.2%Topical Glyceryl Trinitrate in Treatment of Chronic Anal Fissure: a Randomized Controlled Trial

the duration of time needed for complete healing defined as reepithelialization of the anoderm at the site of anal fissure

degree of relief of anal pain as measured by visual analogue scale (VAS) from 0 to 10 where 0 indicates no pain and 10 indicates the worst severe pain.

Sameh Emile

Lecturer of general surgery

Mansoura University

MED2005 (0.2% GTN) gel to be used topically in Part 1 of the study

MED2005 (0.4% GTN) gel to be used topically in Part 1 of the study

MED2005 (0.6% GTN) gel to be used topically in Part 1 of the study

3 x 0.6 mg tablets will be required to make up the 1.8 mg dose to be used orally in Part 1 of the study but to be dosed in two treatment periods

MED2005 (0.8% GTN) gel to be used topically in Part 1 of the study

GTN solution for infusion (1 mg/ml) to be used intravenously in Part 2 of the study

MED2005 (0.8% GTN) gel to be used topically in Part 2 of the study

Erectile Dysfunction

(Day -1 to Day 1): Subjects will undergo six treatment periods, each separated by at least a two day washout. Each treatment period will be approximately 1 day in duration from the afternoon of Day -1 to the afternoon of Day 1 at 6 hours (h) post-dose. In each of the treatment periods, the subject will receive one of the six administrations over 6 treatment periods (1/period) and will return approximately two days later for the next treatment period.

MED2005

Active comparator to be used for Part 1 of the study. Nitrostat will be dosed in two treatment periods and 3 x 0.6 mg tablets will be required to make up the 1.8 mg dose.

Nitrostat 0.6Mg Sublingual Tablet

to be dosed intravenously in Part 2 of the study

Nitro Pohl

Simbec Research Limited

Evaluating MED2005 & Nitrostat Bioavailability

A Single Centre, Open-label, Randomised, Single Dose, Six Period, Reference Replicate, Crossover Study to Evaluate the Bioavailability of MED2005

The primary objective of this human pharmacology study is to demonstrate similar or lower bioavailability of GTN

The percentage of drug metabolites in the bloodstream following administration of MED2005 (test formulation) with Nitrostat (reference) (part 1) will be compared and evaluated.

The incidence of treatment-emergent AEs (TEAE) will be summarised by organ system, preferred term, severity and relationship to study drug. AEs will be identified via abnormal vital signs, abnormal 12-lead ECG parameters, and/or abnormal laboratory safety data

To quantify the amount of GTN remaining on the glans penis post application of MED2005 (Part 2).

I.V. dosing to quantify a figure of 100% GTN being absorbed (Part 2).

the percentage of drug metabolites in the bloodstream following administration of MED2005 (test formulation) with Nitrostat (reference) (part 1) will be compared and evaluated.

Futura Medical Developments Ltd.

About 60 patients will be considered to be in control group receiving vaseline ointment as the placebo applying 2 times daily on their ulcers for 8 weeks.

About 30 patients will receive Diltiazem Gel 2% applying 2 times daily for 8 weeks on their digital ulcers.

About 30 patients will receive nitroglycerin 2% applying 2 times daily for 8 weeks on their digital ulcers.

Digital Ulcer of Scleroderma

This a topical agent which will be applied on digital ulcers by scleroderma patients.

Diltiazem Gel 2%

Nitroglycerin Ointment 2%

This is used as the topical placebo agent.

Vaseline

Rheumatology Reseach Center, Shiraz University of Medical Sciences, Shiraz, Iran.

Diltiazem Gel Versus Nitroglycerin Ointment in Healing Process of Scleroderma Digital Ulcers

Assessing and Comparing the Effect of Diltiazem Gel Versus Nitroglycerin Ointment in Healing Process of Scleroderma Digital Ulcers.

The individual characteristic and information of the patients will be preserved by the researches and won't be released.

Mohammad Ali Nazarinia

Associate Professor of Rheumatology, Shiraz University of Medical Sciences, Shiraz, Iran.

Shiraz University of Medical Sciences

Chronic Anal Fissure

375 mg of ointment(1,5 mg of glyceryl trinitrate ) / 12h DURING 6 MONTHS

Rectogesic® (glyceryl trinitrate 0.4% ointment)

Coloproctology Unit. Elche Hospital

Perianal Versus Endoanal Application of Glyceryl Trinitrate 0.4% Ointment for Chronic Anal Fissure

Perianal vs Endoanal Application of Glyceryl Trinitrate 0.4% Ointment in the Treatment of Chronic Anal Fissure: Results of a Randomized Controlled Trial.

fissure in ano/cefalea

Topical Minoxidil Versus Topical Glyceryl Trinitrate in Treatment of Chronic Anal Fissure

Evaluating MED2005 & Nitrostat Bioavailability

Diltiazem Gel Versus Nitroglycerin Ointment in Healing Process of Scleroderma Digital Ulcers

Perianal Versus Endoanal Application of Glyceryl Trinitrate 0.4% Ointment for Chronic Anal Fissure

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