CIC |
Johanson, 20073838. Johanson JF, Ueno R. Lubiprostone, a locally acting chloride channel activator, in adult patients with chronic constipation: a double-blind, placebo-controlled, dose-ranging study to evaluate efficacy and safety. Aliment Pharmacol Ther . 2007;25:1351-61. |
USA |
129 CIC patients |
Lubiprostone 24 (n=30), 48 (n=32) or 72 mcg (n=34) |
Placebo (n=33) |
Mean number of SBMs per week |
|
Johanson, 20083232. Johanson JF, Morton D, Geenen J, Ueno R. Multicenter, 4-Week, Double-Blind, Randomized, Placebo-Controlled Trial of Lubiprostone, a Locally-Acting Type-2 Chloride Channel Activator, in Patients With Chronic Constipation. Am J Gastroenterol . 2008;103:170-7. |
USA |
242 CIC patients |
Lubiprostone 48 mcg (n=120) |
Placebo (n=122) |
Number of SBMs after 1 week |
|
Barish, 20091919. Barish CF, Drossman D, Johanson JF, Ueno R. Efficacy and Safety of Lubiprostone in Patients with Chronic Constipation. Dig Dis Sci. 2010;55:1090-7. |
USA |
237 CIC patients |
Lubiprostone 48 mcg (n=119) |
Placebo (n=118) |
Number of SBMs after 1 week |
|
Fukudo, 20112020. Fukudo S, Hongo M, Kaneko H, Ueno R. Efficacy and safety of oral lubiprostone in constipated patients with or without irritable bowel syndrome: a randomized, placebo-controlled and dose-finding study. Neurogastroenterol Motil . 2011;23:544-e205. |
Japan |
170 constipation patients with or without IBS |
Lubiprostone 16 (n=41), 32 (n=43) or 48 mcg (n=44) |
Placebo (n-42) |
Change from baseline in the weekly average number of SBMs at week 1 |
|
Fukudo, 20153131. Fukudo S, Hongo M, Kaneko H, Takano M, Ueno R. Lubiprostone Increases Spontaneous Bowel Movement Frequency and Quality of Life in Patients With Chronic Idiopathic Constipation. Clin Gastroenterol Hepatol . 2015;13:294-301.e5. |
Japan |
124 CIC patients |
Lubiprostone 48 mcg (n=62) |
Placebo (n=62) |
Change from baseline in the weekly mean number of SBMs after 1 week |
|
Christie, 20163030. Christie J, Shroff S, Shahnavaz N, Carter LA, Harrison MS, Dietz-Lindo KA, et al. A Randomized, Double-Blind, Placebo-Controlled Trial to Examine the Effectiveness of Lubiprostone on Constipation Symptoms and Colon Transit Time in Diabetic Patients. Am J Gastroenterol . 2017;112:356-64. |
USA |
76 CIC patients |
Lubiprostone 48 mcg (n=37) |
Placebo (n=39) |
Difference in number of SBMs per week from baseline |
IBS-C
|
Johanson, 20082929. Johanson JF, Drossman DA, Panas R, Wahle A, Ueno R. Clinical trial: phase 2 study of lubiprostone for irritable bowel syndrome with constipation. Aliment Pharmacol Ther. 2008;27:685-96. |
USA |
195 IBS-C patients |
Lubiprostone 16 (n=51), 32 (n=49) or 48 mcg (n=45) |
Placebo (n=48) |
Change from baseline in mean abdominal pain score (1 month) |
|
Drossman, 20093333. Drossman DA, Chey WD, Johanson JF, Fass R, Scott C, Panas R, et al. Clinical trial: lubiprostone in patients with constipation-associated irritable bowel syndrome - results of two randomized, placebo-controlled studies. Aliment Pharmacol Ther . 2009;29:329-41. |
USA |
1171 Rome II IBS-C patients (pooled results of 2 RCTs) Study 0431 n=590 Study 0432 n=581 |
Lubiprostone 48 mcg (n=769) |
Placebo (n=385) |
Overall responder rate |
OIC |
Cryer, 20142121. Cryer B, Katz S, Vallejo R, Popescu A, Ueno R. A Randomized Study of Lubiprostone for Opioid-Induced Constipation in Patients with Chronic Noncancer Pain. Pain Med . 2014;15:1825-34. |
USA and Canada |
418 chronic noncancer pain patients |
Lubiprostone 48 mcg (n=210) |
Placebo (n=208) |
Change from baseline in the frequency of SBMs at week 8 |
|
Jamal, 20153636. Jamal MM, Adams AB, Jansen J-P, Webster LR. A Randomized, Placebo-Controlled Trial of Lubiprostone for Opioid-Induced Constipation in Chronic Noncancer Pain. Am J Gastroenterol . 2015;110:725-32. |
USA and EU |
431 chronic noncancer pain patients using non-methadone opioid |
Lubiprostone 48 mcg (n=214) |
Placebo (n=217) |
Overall SBM response rate |
|
Spierings, 20173939. Spierings ELH, Drossman DA, Cryer B, Mazen Jamal M, Losch-Beridon T, Mareya SM, et al. Efficacy and Safety of Lubiprostone in Patients with Opioid-Induced Constipation: Phase 3 Study Results and Pooled Analysis of the Effect of Concomitant Methadone Use on Clinical Outcomes. Pain Med . 2018;19:1184-94. |
USA |
451 chronic noncancer pain patients |
Lubiprostone 48 mcg (n=224) |
Placebo (n=213) |
Change from baseline in frequency of SBMs at week 8 |