Clinical Trial to assess the efficacy and tolerability of 2% diltiazem hydrochloride versus placebo in the treatment of chronic anal fissure with a follow up period of 24 weeks.

Phase 1

• Conditions: 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: 19.0Level: LLTClassification code 10071195Term: Chronic anal fissureSystem Organ Class: 100000004856; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2015-003627-54-ES
• Lead Sponsor: Tecnimede, Sociedade Técnico-Medicinal, S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-18
• Last Update Posted: 20 August 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 220

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 180
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

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 New York Heart Association (NYHA) class III and IV heart failure, atrial fibrillation caused by Wolff-Parkinson-White or Lown-Ganong-Levine syndromes, second and third degree atrioventricular block or sinoatrial node disease (except in the presence of a functioning artificial ventricular pacemaker), myocardial infarction with an ejection fraction below 0.40, ventricular tachycardia, severe bradycardia (lower than or equal to 40 beats per minute) or severe aortic stenosis.
8. Patients with orthostatic (postural) hypotension or severe hypotension (systolic blood pressure below 90 mmHg).
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 human immunodeficiency virus (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.
15. Patients with any changes in the previous 12 weeks to oral, sublingual ,intravenous or intra-muscular therapy with vasodilators (beta blockers, nitrates, calcium antagonists, phosphodiesterase 4 inhibitors) or muscle relaxants;(for example infusion of dantroleno).
16. Use of glyceryl trinitrate (GTN) ointment for 7 days (continuous or not) in the 4 weeks prior to signing the informed consent form (ICF).
17. Previous treatment with diltiazem hydrochloride cutaneous formulations or any other topical calcium channel blockers in the 8 weeks before randomization.
18. Patients who used an analgesic, anesthetic, cicatrizant, other 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.
19. History of hypersensitivity or intolerance to any of the investigational medicinal products, or to their active substances or excipients, or to similar drugs;
20. Patients with clotting disorders;unless the patients are taking anticoagulants drugs and the investigator considers that the International Normalized Ratio (INR) is adequate and stable.
21. Any known abnormal clinical or laboratory change that, as per the investigator, might interfere with the safety or efficacy assessment or any study procedure;
22. Patients who have participated in another clinical trial less than one month prior to enrolment or who are still in

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified