Cronic Anal fissure (CAF) The underlying pathogenesis of chronic anal fissure involves initial local trauma (generally caused by hard stools), resulting in a wound, internal anal sphincter spasm and reduced blood flow to the anal mucosa. The last two factors contribute to the appearance of an ulcer that does not heal, given that perfusion is inversely correlated with anal pressure. MedDRA version: 16.0 Level: LLT Classification code 10071195 Term: Chronic anal fissure System Organ Class: 100000
Conditions
Interventions
Trade Name: Anotrit
Product Name: Diltiazem 2% paste
Product Code: 0002
Pharmaceutical Form: Cutaneous paste
INN or Proposed INN: Diltiazem Hydrochloride
CAS Number: 33286-22-5
Concentration unit: % (
Ubiquinone 10
Concentration unit: % (W/W) percent weight/weight
Concentration type: equal
Concentration number: 4-
INN or Proposed INN: Dexpanthenol
CAS Number: 81-13-0
Concentration unit: % (W/W) per
Sponsors
Tecnimede, Sociedade Técnico-Medicinal S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this clinical trial is to assess the relative efficacy of the concomitant administration of an UDC cream and DTZ2% paste with the administration of DTZ2% paste alone, with a chronic anal fissure (CAF) treatment phase of 8 weeks. ;Secondary Objective: Secondary objectives include the comparison between the two treatment arms of: a) improvement of symptoms (pain) within 8 weeks of treatment; b) improvement of symptoms (pain) within 4 weeks of treatment; c) cure rate within 4 weeks of treatment; d) tolerability within 8 weeks of treatment; e) CAF relapse rate during a 24 week follow up period.;Primary end point(s): Proportion of patients for which CAF cure (defined as total closing of anal fissure observed in the physical examination) was observed during the 8 week treatment period.;Timepoint(s) of evaluation of this end point: During the 8 week treatment period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.Symptomatic improvement assessed as variation in millimeters, using a visual analogue scale (VAS) for pain applied on the 8th week of treatment (visit 4 – V4); 2.Symptomatic improvement assessed as variation in millimeters, using a visual analogue scale (VAS) for pain applied on the 4th week of treatment (visit 3 – V3); 3.Proportion of patients for which cure of the CAF was observed until the 4th week of treatment (visit 2 and 3 - V2 and V3); 4.Proportion of patients with relapsing disease during a 24-week follow up period after treatment withdrawal (final visit VF). 5.No. of adverse events (AE) reported for each treatment arm during the total duration of the study; 6.No. of serious and/or unexpected adverse reactions reported for each treatment arm during the total duration of the study. ;Timepoint(s) of evaluation of this end point: 1. Visit 4 - the 8th week of treatment 2. Visit 3 - the 4th week of treatment 3. Visit 2 and 3 - Until the 4th week of treatment. 4. During a 24-week follow up period after treatment withdrawal - Final Visit 5.Total duration of the study 6. Total duration of the study | — |
Countries
Czech Republic, Portugal, Spain
Contacts
Public ContactMedical Department
Tecnimede Sociedade Técnico Medicinal, S.A.
Outcome results
None listed