Effect of Mesalazine plus nifedipine suppositoires (Antrorect) in functional ano-rectal pain disorders: a pilot randomized double-blind placebo-controlled study. - ND

Conditions: Functional ano-rectal pain disorders
MedDRA version: 9.1Level: LLTClassification code 10058446

Registration Number: EUCTR2010-023938-23-IT

Lead Sponsor: BRACCO

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

• Patients who have given their free and informed consent. • Male or female patients aged between 18 and 70 years. • A positive diagnosis of functional ano-rectal pain, according to Rome III criteria1. • At least ano-rectal pain once a week in the last 3 months with symptom onset at least 6 months prior to diagnosis (to be confirmed also after the run-in period) • Patients capable of conforming to the study protocol (patient’s diary to be filled in daily) and to co-operate with the treatment.
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

• Patients with organic causes of ano-rectal pain such as hemorrhoidal thrombophlebitis, ischemia, IBD, cryptitis, intramuscular abscess, anal fissures, hemorrhoids (III and IV degree), prostatitis, and coccygodynia. First and second degree haemorrhoids do not represent an exclusion criteria. • Patients with previous ano-rectal surgery at least 5 years apart. • Hypersensitivity or allergy to nifedipine, mesalazine, other salicylates (including aspirin), or to any component of the rectal suppositories, including the suppository vehicle. • Pregnancy and breastfeeding as well as females of childbearing potential, in the absence of effective contraceptive methods. • Presence of severe psychiatric disorders (e.g. bipolar disorder, eating disorders, alcohol or drug addiction, etc). • Treatment with any investigational drug within the previous 30 days.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The study was designed to test safety and efficacy of the novel medication (Antrorect) combining mesalazine 1 g (an anti-inflammatory compound) plus nifedipine 10 mg (a calcium channel blocker effective in relaxing smooth muscle) suppositories in patients with functional ano-rectal pain.;Secondary Objective: ;Primary end point(s): The Primary efficacy variable will be adequate relief from ano-rectal pain (measured by VAS) with the study medication at the end of treatment (as difference by baseline value), in the group treated with Antrorect as compared with placebo.

Secondary Outcome Measures