Overview of clinical safety with misoprostol

Brand DL, Roufail WM, Thomson ABR, Tapper EJ: Misoprostol, a synthetic PGE1 analog, in the treatment of duodenal ulcers: A multicenter double-blind study. Dig Dis Sci 30 (Nov Suppl.):147S-158S, 1985

Sontag SJ, Mazure PA, Pontes JF, Beker SG, Dajani EZ: Misoprostol in the treatment of duodenal ulcer: a multicenter double-blind placebo controlled study. Dig Dis Sci 30 (Nov Suppl.):159S-163S, 1985

Agrawal NM, Saffouri B, Kruss DM, Callison DA, Dajani EZ: Healing of benign gastric ulcer: A placebo-controlled comparison of two dosage regimens of misoprostol, a synthetic analog of prostaglandin E1. Dig Dis Sci 30 (Nov Suppl.):164S-170S, 1985

Nicholson PA: A multicenter international controlled comparison of two dosage regimens of misoprostol and cimetidine in the treatment of duodenal ulcer in out-patients. Dig Dis Sci 30 (Nov Suppl.):171S-177S, 1985

Shield MJ: Interim results of a multicenter international comparison of misoprostol and cimetidine in the treatment of out-patients with benign gastric ulcers. Dig Dis Sci 30 (Nov Suppl.):178S-184S, 1985

Guidelines for Detection of Hepatotoxity Due to Drugs and Chemicals.In US Department of Health, Education and Welfare. CS Davidson, CM Leevy, EC Chamberlayne (eds). NIH Publication, October 1979, 7:79?313

Five-week safety assessment study (JA 0013) conducted for Japanese registration, at the Central Institute for Experimental Animals, Kawasaki City, Japan, 1982

A Study of the Effect of Misoprostol (SC-29333) on Platelet Aggregation, Respiratory and Endocrine Function in Volunteer Subjects. G.D. Searle and Co. Report No. E35-83-06-069, 1983

A Multiclinic, Double-Blind, Placebo Controlled Study of Prophylactic Misoprostol Therapy for Prevention of Recurrence of Duodenal Ulcers. G.D. Searle and Co. Protocol No. N63-83-02-031, 1983

Thirteen-Week Oral Toxicity Study of Stabilized SC-29333 in Dogs (Hazleton Laboratories, America Inc., Vienna VA) PS-81C, 1585A, 1981

Stejskal R, Roubier C, Regnier B: One Year Oral Toxicity Study of Stabilized SC-29333 in the Dog. Department of Product Safety Assessment, Searle Research and Development, PS-83F-0052A, 1983

Goldman H, Antonioli DA: Mucosal biopsy of the esophagus, stomach and proximal duodenum. Hum Pathol 13:423?448, 1982

Oohara T, Sadatsuki H, Kaminishi M, Mitarai Y: Simple alkaline treatment induces intestinal metaplasia in the stomach of rats. Path Res Pract 175:365?372, 1982

Morson BC, Sobin LH, Grundmann E, Johansen A, Nagayo T, Serck-Hanssen A: Precancerous conditions and epithelial dysplasia of the stomach. J Clin Pathol 33:711?721, 1980

Grundmann E, Schlake W: Histology of possible precancerous stages in the stomach.In Gastric Cancer, C Herford, P Schlag (eds). Heidelberg, Springer-Verlag 1979, pp 72?82.

Misoprostol versus Placebo in the Treatment of Gastric Ulcer. G.D. Searle and Co. Protocol No. MED-81-02-001, 1981