Clinical trial: oral colon-release parnaparin sodium tablets (CB-01-05 MMX) for active left-sided ulcerative colitis.

Abstract

BACKGROUND:

The administration of parnaparin sodium as oral colon-release tablets (CB-01-05 MMX) has been proposed as a novel approach for the treatment of ulcerative colitis (UC).

AIM:

To assess the efficacy and the tolerability of 8 weeks' oral daily administration of 210 mg of parnaparin sodium compared with placebo in subjects treated with stable-doses of oral aminosalicylates.

METHODS:

This multicenter, randomized, double-blind proof of concept trial compared the efficacy of CB-01-05 MMX 210 mg tablets to placebo in 141 subjects with mild to moderately active left-sided UC treated with stable-doses of aminosalicylates. The efficacy was assessed by clinical activity index (CAI), endoscopic index (EI) and histological score (HS).

RESULTS:

A total of 121 subjects (61 in test group and 60 in control group) formed the per protocol (PP) population. After 8 weeks of treatment, clinical remission was achieved in 83.6% of the CB-01-05 MMX group, and in 63.3% in the comparator group (P = 0.011). This effect was also significantly evident in the test group at week 4 (P = 0.028). A significant difference was also detected in rectal bleeding, (disappeared respectively in 75.4% and 55.0%; P = 0.018), and in mucosal friability (recovered respectively in 80.3% and in 56.7%; P = 0.005).

CONCLUSIONS:

CB-01-05 MMX was safe and significantly effective in treating subjects with mild-to-moderate left-sided UC treated with stable-doses of aminosalicylates.

• Authors: G Celasco, A Papa, R Jones, L Moro, R Bozzella, M M Surace, G C Naccari, G Gasbarrini
• Journal: Alimentary pharmacology & therapeutics (Aliment Pharmacol Ther) Vol. 31 Issue 3 Pg. 375-86 (Feb 01 2010) ISSN: 1365-2036 [Electronic] England
• PMID: 19891665 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Anticoagulants
• Delayed-Action Preparations
• Heparin, Low-Molecular-Weight
• parnaparin

Topics

• Administration, Oral
• Adolescent
• Adult
• Aged
• Anticoagulants (administration & dosage, adverse effects)
• Colitis, Ulcerative (drug therapy, physiopathology)
• Colon (drug effects, physiopathology)
• Delayed-Action Preparations
• Dose-Response Relationship, Drug
• Double-Blind Method
• Female
• Heparin, Low-Molecular-Weight (administration & dosage, adverse effects)
• Humans
• Male
• Middle Aged
• Treatment Outcome
• Young Adult