HOMEPRODUCTSCOMPANYCONTACTFAQResearchDictionaryPharmaSign Up FREE or Login

A randomised, controlled, double blind, escalating dose study of alicaforsen enema in active ulcerative colitis.

AbstractOBJECTIVE:
To evaluate the safety and efficacy of an enema formulation of alicaforsen, an antisense inhibitor of intercellular adhesion molecule, after 1, 3, and 6 months.
METHODS:
This was a randomised, placebo controlled, double blind, escalating dose multicentre study in 40 patients with mild to moderately active distal ulcerative colitis (disease activity index (DAI) 4-10). Patients were assigned to four dosing cohorts of 10 patients each (eight active, two placebo). Each patient received 60 ml of alicaforsen enema (0.1, 0.5, 2, or 4 mg/ml or placebo) once daily for 28 consecutive days. Safety and efficacy (DAI and clinical activity index) scores were evaluated up to six months after initiation of dosing.
RESULTS:
At day 29, alicaforsen enema resulted in dose dependent improvement in DAI (overall p = 0.003). Alicaforsen 4 mg/ml improved DAI by 70% compared with the placebo response of 28% (p = 0.004). Alicaforsen 2 and 4 mg/ml improved DAI status by 72% and 68% compared with a placebo response of 11.5% at month 3 (p = 0.016 and 0.021, respectively). Specifically, DAI improved from 5.6 to 1.6 and from 6.3 to 2.5 in the 2 and 4 mg/ml groups compared with placebo (7.5 to 6.1). None of the patients in the 4 mg/ml group compared with 4/8 placebo patients required additional medical or surgical intervention over baseline during the six month period after starting the enema treatment. The safety profile was favourable.
CONCLUSIONS:
Alicaforsen enema showed promising acute and long term benefit in patients with mild to moderate descending ulcerative colitis. Alicaforsen enemas had a favourable safety profile. These findings require verification in larger randomised controlled clinical trials.
AuthorsS J H van Deventer, J A Tami, M K Wedel
JournalGut (Gut) Vol. 53 Issue 11 Pg. 1646-51 (Nov 2004) ISSN: 0017-5749 [Print] England
PMID15479686 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Gastrointestinal Agents
  • Oligodeoxyribonucleotides, Antisense
  • Phosphorothioate Oligonucleotides
  • Thionucleotides
  • Intercellular Adhesion Molecule-1
  • alicaforsen
Topics
  • Adult
  • Colitis, Ulcerative (drug therapy)
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Enema
  • Female
  • Gastrointestinal Agents (administration & dosage, adverse effects, therapeutic use)
  • Humans
  • Intercellular Adhesion Molecule-1 (immunology)
  • Male
  • Middle Aged
  • Oligodeoxyribonucleotides, Antisense (administration & dosage, adverse effects, therapeutic use)
  • Phosphorothioate Oligonucleotides
  • Severity of Illness Index
  • Thionucleotides (administration & dosage, adverse effects, therapeutic use)
  • Treatment Outcome

Join CureHunter, for free Research Interface BASIC access!

Take advantage of free CureHunter research engine access to explore the best drug and treatment options for any disease. Find out why thousands of doctors, pharma researchers and patient activists around the world use CureHunter every day.
Realize the full power of the drug-disease research graph!


Choose Username:
Email:
Password:
Verify Password:
Enter Code Shown: