Abstract | BACKGROUND: AIM: METHODS: Randomized, placebo-controlled, double-blind, two-dose ranging multicentre study. One hundred and twelve subjects were equally randomized to receive one of four alicaforsen enema regimens or placebo daily for 6 weeks. Primary end point was Disease Activity Index at week 6. Secondary end points included evaluation of clinical improvement, relapse rates and durability of response. Analysis of data were performed on the intent-to-treat population. RESULTS: No significant difference was observed between treatment arms and placebo in the primary end point. A prolonged reduction in mean% Disease Activity Index relative to baseline was observed in the daily 240 mg alicaforsen enema treatment arm in comparison with placebo from week 18 (51% vs. 18%, P=0.04) to week 30 (50% vs. 11%, P=0.03). CONCLUSIONS:
Alicaforsen enema was safe and well tolerated at all doses studied. The durability of the response to alicaforsen enema treatment may suggests a disease-modifying effect.
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Authors | S J H van Deventer, M K Wedel, B F Baker, S Xia, E Chuang, P B Miner Jr |
Journal | Alimentary pharmacology & therapeutics
(Aliment Pharmacol Ther)
Vol. 23
Issue 10
Pg. 1415-25
(May 15 2006)
ISSN: 0269-2813 [Print] England |
PMID | 16669956
(Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Gastrointestinal Agents
- Oligodeoxyribonucleotides, Antisense
- Phosphorothioate Oligonucleotides
- Thionucleotides
- alicaforsen
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Topics |
- Adult
- Aged
- Colitis, Ulcerative
(drug therapy)
- Double-Blind Method
- Drug Administration Schedule
- Enema
- Female
- Gastrointestinal Agents
(administration & dosage, adverse effects)
- Gastrointestinal Hemorrhage
(etiology)
- Humans
- Male
- Middle Aged
- Oligodeoxyribonucleotides, Antisense
(administration & dosage, adverse effects)
- Phosphorothioate Oligonucleotides
- Rectum
- Recurrence
- Thionucleotides
(administration & dosage, adverse effects)
- Treatment Outcome
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