Phase II study of the safety and efficacy of a 5-lipoxygenase inhibitor in patients with ulcerative colitis

Am J Gastroenterol. 1992 Mar;87(3):342-6.


We examined the effects of an inhibitor of 5-lipoxygenase (A-64077) in 11 patients with mild to moderately active ulcerative colitis (UC). Treatment was a daily oral dose of 800 mg for 28 days. Physicians global rating (scale 1-50) included stool characteristics, rectal bleeding, abdominal and rectal pain, urgency, and general well being; sigmoidoscopic evaluation (scale 1-15) included mucosal vascular pattern, erythema, granularity/ulcerations, friability, and exudate. All of the patients experienced a decrease in discomfort of their disease, and the gross appearance in the sigmoidoscopy improved in eight of them, but were not accompanied by histologic improvement. No significant side effects occurred. A long-term controlled double-blind and dose-effect trial using 5-lipoxygenase inhibitors is needed which may lead to a new therapeutic approach in UC.

Publication types

  • Clinical Trial

MeSH terms

  • Administration, Oral
  • Adult
  • Anti-Inflammatory Agents, Non-Steroidal / therapeutic use*
  • Colitis, Ulcerative / drug therapy*
  • Colitis, Ulcerative / pathology
  • Drug Evaluation
  • Female
  • Humans
  • Hydroxyurea / analogs & derivatives*
  • Hydroxyurea / therapeutic use
  • Lipoxygenase Inhibitors / therapeutic use*
  • Male
  • Sigmoidoscopy


  • Anti-Inflammatory Agents, Non-Steroidal
  • Lipoxygenase Inhibitors
  • zileuton
  • Hydroxyurea