Clinical trial of the combination of a cream containing ubidecarenone, dexpanthenol and chlorohexidine and a paste containing 2% diltiazem in the treatment of chronic anal fissure.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 240

Inclusion Criteria

1.Patients aged 18 years old or above; 2.Diagnosis of idiopathic chronic anal fissure unresponsive to previous therapy,
3. Patient able to comply with the study protocol as per investigator criteria; 4.Signed and dated informed consent by the patient or his/her representative/witness (as per applicable law). 5.Absence of any exclusion criterion.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Patient presenting with any of the clinical conditions mentioned below. a.Anal fissure lacking features for chronicity;b.Cured anal fissure;c.Infected chronic anal fissure;d.Multiple fissures;e.Fissure with irregular margins; f. Fissure at locations other than the midline; g.Fissure unassociated to sphincter spasm;2.Patients with fecal incontinence, rectocele, rectal prolapse or fibrotic anal stenosis;3.Patients with prior anal surgery; 4.Patients treated with botulinum toxin less than 6 months prior to enrolment;5.Patients with chronic anal fissure secondary to other disorders such as chronic inflammatory bowel disease, intestinal tuberculosis, anal or peri-anal cancer, anal fistula, sexually transmitted diseases, anal or peri-anal sepsis;6.Patients with malignant diseases and a life expectancy of less than 1 year or patients undergoing chemo- or radiotherapy less than 6 months prior to enrolment; 7.Patients with clinically significant cardiovascular disorder, namely NYHA class III and IV heart failure, atrial fibrillation, atrioventricular block, or clinically significant bradycardia; 8.Patients with orthostatic (postural) hypotension;9.Patients with respiratory insufficiency and need for long term oxygen therapy or home ventilation;10.Patients with clinically significant renal failure;11.Patients with known HIV infection; 12.Patients with known neuromuscular disease;13.Pregnant or lactating patients; 14.Women of childbearing potential who are sexually active and who do not use an effective contraceptive method. The following are considered to be effective contraceptive methods: intra-uterine device (IUD), oral contraceptives, injected contraceptives, contraceptive implants, surgical sterilization of partner (vasectomy with negative sperm count and in a monogamous relationship). In case barrier methods are used, double protection methods (condoms, spermicidal, diaphragm and similar) are deemed effective;15.Patients with any changes in the previous 12 weeks to oral, sublingual or intra-muscular therapy with vasodilators (beta blockers, nitrates, calcium antagonists, phosphodiesterase 4 inhibitors) or muscle relaxants;16.Patients who used an analgesic, anesthetic, cicatrizant, topical vasodilators, corticosteroid, vitamins A or E, or any other active substances that might be active in anal mucosa regeneration, less than 3 days before.17.History of hypersensitivity or intolerance to any of the investigational medicinal products, or to their active substances or excipients, or to similar drugs;18.Patients with clotting disorders;19.Any known abnormal clinical or laboratory change that, as per the investigator, might interfere with the safety or efficacy assessment or any study procedure;20.Patients who have participated in another clinical trial less than one month prior to enrolment or who are still involved in another trial.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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