Trial reportGut2004
A randomised, controlled, double blind, escalating dose study of alicaforsen enema in active ulcerative colitis.
Trial report in Gut, 2004. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 38 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
38 citing papers in PubMed, 3 syntheses or guidelines pooled it, 148 citations in OpenAlex.
- Placebo response and remission rates in randomised trials of induction and maintenance therapy for ulcerative colitis.The Cochrane database of systematic reviews · 2017Pooled it
- Systematic Review and Meta-analysis: Placebo Rates in Induction and Maintenance Trials of Ulcerative Colitis.Journal of Crohn's & colitis · 2016Pooled it
- Meta-analysis of the placebo response in ulcerative colitis.Digestive diseases and sciences · 2008Pooled it
- Targeting T-cell integrins in autoimmune and inflammatory diseases.Clinical and experimental immunology · 2024Review
- Review
- The Role of the Lymphatic System in the Pathogenesis and Treatment of Inflammatory Bowel Disease.International journal of molecular sciences · 2022Review
- Innovative, complementary and alternative therapy in inflammatory bowel diseases: A broad 2020s update.Frontiers in gastroenterology (Lausanne, Switzerland) · 2022Review
- Targeting Immune Cell Trafficking - Insights From Research Models and Implications for Future IBD Therapy.Frontiers in immunology · 2021Review
- Topical Therapy with Antisense Tumor Necrosis Factor Alpha Using Novel β-Glucan-Based Drug Delivery System Ameliorates Intestinal Inflammation.International journal of molecular sciences · 2020Article
- Review
- Therapeutic Oligonucleotides for Patients with Inflammatory Bowel Diseases.Biologics : targets & therapy · 2020Review
- Targeting immune cell circuits and trafficking in inflammatory bowel disease.Nature immunology · 2019Review
- Inflammatory Cytokine Profile in Crohn's Disease Nonresponders to Optimal Antitumor Necrosis Factor Therapy.Journal of clinical gastroenterology · 2019Article
- Oligonucleotides-A Novel Promising Therapeutic Option for IBD.Frontiers in pharmacology · 2019Review
- Ultrasound-Mediated Delivery of RNA to Colonic Mucosa of Live Mice.Gastroenterology · 2017Article
- Nanomedicine and drug delivery strategies for treatment of inflammatory bowel disease.World journal of gastroenterology · 2015Review
- DNA and RNA derivatives to optimize distribution and delivery.Advanced drug delivery reviews · 2015Review
- Review
- Targeting leukocyte trafficking for the treatment of inflammatory bowel disease.Clinical pharmacology and therapeutics · 2015Review
- Alicaforsen: An Emerging Therapeutic Agent for Ulcerative Colitis and Refractory Pouchitis.Gastroenterology research · 2014Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo evaluate the safety and efficacy of an enema formulation of alicaforsen, an antisense inhibitor of intercellular adhesion molecule, after 1, 3, and 6 months.
methodsThis 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.
resultsAt 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.
conclusionsAlicaforsen 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.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.