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

Alfredo Papa, Giovanni Battista Gasbarrini, G. Celasco, R. Jones, L. Moro, R. Bozzella, M. M. Surace, G. C. Naccari

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23 Citations (Scopus)

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.
Original languageEnglish
Pages (from-to)375-386
Number of pages12
JournalALIMENTARY PHARMACOLOGY & THERAPEUTICS
Volume2010 (31)
Publication statusPublished - 2010

Keywords

  • colon-release
  • low-molecular weight heparin
  • parnaparin
  • therapy
  • ulcerative colitis

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