Functional ano-rectal pain disorders MedDRA version: 9.1 Level: LLT Classification code 10058446
Conditions
Interventions
Product Name: Antrorect
Pharmaceutical Form: Suppository
Current Sponsor code: Antrorect
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the pla
Sponsors
BRACCO
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Italy
Outcome results
None listed