Lubiprostone (Amitiza®) Vs. Standard Care in Opioid-induced Constipation After Surgery in Inpatient Rehabilitation

Summary

Patients requiring opioids for post-operative pain control following elective orthopedic procedures which has resulted in constipation symptoms, and who are in inpatient rehabilitation will be randomized to two different treatment arms: lubiprostone or senna. Baseline scores regarding constipation and a quality of life bowel questionnaire will be compared the day following 6 days of treatment intervention.

Timeline

Start

2008-04

Primary completion

2011-10

Completion

2011-10

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Lubiprostone vs Senna; p <0.05; independent sample t test NCT00662363 ↗

paper no significant differences between the lubiprostone and Senna groups in mean change in the PAC-SYM (-0.20 ± 0.60 vs -0.36 ± 0.61, P = 0.61 respectively) PMID 25473191 ↗

Publications

• Marciniak CM, Toledo S, Lee J, Jesselson M, Bateman J, Grover B, Tierny J. Lubiprostone vs Senna in postoperative orthopedic surgery patients with opioid-induced constipation: a double-blind, active-comparator trial. World J Gastroenterol. 2014 Nov 21;20(43):16323-33. doi: 10.3748/wjg.v20.i43.16323.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lubiprostone	Small molecule	24 ug	Oral
Comparator	Senna	Traditional medicine (herbal / TCM)	17.2 mg	—

Indications