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

Alimentary Pharmacology and Therapeutics

Volumn 31, Issue 3, 2010, Pages 375-386

  Celasco, G ^a   Papa, A ^b   Jones, R ^c   Moro, L ^a   Bozzella, R ^a   Surace, M M ^a   Naccari, G C ^c   Gasbarrini, G ^b  

^a Research and Development   (Italy)

^b CATHOLIC UNIVERSITY   (Italy)

^c Cosmo Technologies Ltd ^*  (Ireland)

Author keywords

[No Author keywords available]

Indexed keywords

AMINOSALICYLIC ACID DERIVATIVE; C REACTIVE PROTEIN; MESALAZINE; MMX; PARNAPARIN; PLACEBO; SALAZOSULFAPYRIDINE; UNCLASSIFIED DRUG;

ABDOMINAL PAIN; ADULT; AGED; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DISEASE EXACERBATION; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG INDUCED HEADACHE; DRUG RELEASE; DRUG TOLERABILITY; EPIGASTRIC PAIN; ERYTHROCYTE SEDIMENTATION RATE; FAINTNESS; FEMALE; FLATULENCE; HEMORRHOID; HUMAN; INTESTINAL NEURONAL DYSPLASIA; LABORATORY TEST; MAJOR CLINICAL STUDY; MALE; MORNING DOSAGE; MULTICENTER STUDY; MYALGIA; NAUSEA; PATIENT COMPLIANCE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RECTUM HEMORRHAGE; REMISSION; SCORING SYSTEM; SIDE EFFECT; SORE THROAT; TABLET FORMULATION; ULCERATIVE COLITIS;

ADMINISTRATION, ORAL; ADOLESCENT; ADULT; AGED; ANTICOAGULANTS; COLITIS, ULCERATIVE; COLON; DELAYED-ACTION PREPARATIONS; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; FEMALE; HEPARIN, LOW-MOLECULAR-WEIGHT; HUMANS; MALE; MIDDLE AGED; TREATMENT OUTCOME; YOUNG ADULT;

EID: 73449149293     PISSN: 02692813     EISSN: 13652036     Source Type: Journal    
DOI: 10.1111/j.1365-2036.2009.04194.x     Document Type: Article

References (24)

1. Torkvist L, Thorlacius H, Sjoquist U, et al. Low molecular weight heparin as adjuvant therapy in active ulcerative colitis. Aliment Pharmacol Ther 1999 13 : 1323 1328.
2. Dotan I, Hallak A, Arber N, et al. Low-dose low-molecular weight heparin (enoxaparin) is effective as adjuvant treatment in active ulcerative colitis: an open trial. Dig Dis Sci 2001 46 : 2239 2244.
3. Vrij AA, Jansem JM, Schoon EJ, et al. Low molecular weight heparin treatment in steroid refractory ulcerative colitis: clinical outcome and influence on mucosal capillary thrombi. Scand J Gastroenterol 2001 (Suppl 234 36 : 41 7.
4. De Bièvre MA, Vrij AA, Schoon EJ, et al. Randomized, placebo-controlled trial of low molecular weight heparin in active ulcerative colitis. Inflamm Bowel Dis 2007 13 : 753 758.
5. Zezos P, Papaioannou G, Nikolaidis N, et al. Low-molecular-weight heparin (enoxaparin) as adjuvant therapy in the treatment of active ulcerative colitis: a randomized, controlled, comparative study. Aliment Pharmacol Ther 2006 23 : 1443 1453.
6. Korzenik J, Miner P Jr., Stanton D, et al. Multicenter, randomized, placebo-controlled trial of deligoparin (ultra low molecular weight heparin) for active ulcerative colitis. Gastroenterology 2003. AGA Abstr. 539 : A67.
7. Bloom S, Kiilwerich S, Lassen MR, et al. Low molecular weight heparin (tinzaparin) vs. placebo in the treatment of mild to moderately active ulcerative colitis. Aliment Pharmacol Ther 2004 19 : 871 878.
8. Shen J, Ran ZH, Tong JL, et al. Meta-analysis: the utility and safety of heparin in the treatment of active ulcerative colitis. Aliment Pharmacol Ther 2007 26 : 653 663.
9. Cui HF, Jiang XL. Treatment of corticosteroid-resistant ulcerative colitis with oral low molecular weight heparin. World J Gastroenterol 1999 5 : 448 450.
10. Celasco G, Moro L, Bozzella R, et al. Efficacy of intracolonic administration of low-molecular weight heparin CB-01-05, compared to other low-molecular weight heparins and unfractionated heparin, in experimentally induced colitis in rat. Dig Dis Sci 2008 53 : 3170 3175. Erratum in Dig Dis Sci 2009; 54:193-4.
11. ® for the treatment of mild-to-moderate left-sided ulcerative colitis. Aliment Pharmacol Ther 2008 28 : 581 588.
12. Rachmilewitz D. Coated mesalazine (5-aminosalicylic acid) versus sulphasalazine in the treatment of active ulcerative colitis: a randomized trial. BMJ 1989 298 : 82 6.
13. Saverymuttu SH, Camilleri M, Rees H, et al. Indium 111-granulocyte scanning in the assessment of disease extent and disease activity in inflammatory bowel disease. Gastroenterology 1986 90 : 121 128.
14. rd ECCO Congress, Lyon 2008. JCC 2008 2 : 85.
15. Truelove SC, Richards WCD. Biopsy studies in ulcerative colitis. Br Med J 1956 9 : 1315 1318.
16. Garud S, Brown A, Cheifetz A, et al. Meta-analysis of the placebo response in ulcerative colitis. Dig Dis Sci 2008 53 : 875 891.
17. Fries W, Pagiaro E, Canova E, et al. The effect of heparin on trinitrobenzene sulphonic acid-induced colitis in the rat. Aliment Pharmacol Ther 1998 12 : 229 236.
18. Hatoum OA, Heidemann J, Binion DG. The intestinal microvasculature as a therapeutic target in inflammatory bowel diseases. Ann NY Acad Sci 2006 1072 : 78 97.
19. Levine A, Kenet G, Bruck R, et al. Effect of heparin on tissue binding activity of fibroblast growth factor and heparin-binding epidermal growth factor in experimental colitis in rats. Pediatr Res 2002 51 : 635 640.
20. Papa A, Danese S, Gasbarrini A, et al. Review article: potential therapeutic applications and mechanisms of action of heparin in inflammatory bowel disease. Aliment Pharmacol Ther 2000 14 : 1403 1409.
21. Michell NP, Lalor P, Langman MJS. Heparin therapy for ulcerative colitis? Effects and mechanisms Eu J Gastroenterol Hepatol 2001 13 : 449 456.
22. Otsuka M, Tsuchiya S, Aramaki Y. Comparison of inhibitory effects of polyanions on nitric oxide production by macrophages stimulated with LPS. Biol Pharm Bull 2006 29 : 499 502.
23. Salas A, Sans M, Soriano A, et al. Heparin attenuates TNF-α induced inflammatory response through a CD11b dependent mechanism. Gut 2000 47 : 88 96.
24. Brunner M, Assandri R, Kletter K, et al. Gastrointestinal transit and 5-ASA release from a new mesalazine extended-release formulation. Aliment Pharmacol Ther 2003 17 : 395 402.