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

NCT00662363 | Completed Results

• 1 other identifier: STU00001168
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Constipation

Keywords

constipation; opioid; rehabilitation; post-operative; orthopedic

Outcome Measures

Primary Outcomes (2)

• Change in Patient Assessment of Constipation (PAC) - Symptoms (Sym)

  Patient Assessment of Constipation (PAC) - Change in this measure was assessed. The PAC has previously been found to be a valid and reliable way to measure constipation symptoms and clinical course. The PAC has two components. The symptom (SYM) component is composed of 12 items with score range 0-4 with lower scores indicating improvement. Scores within the two domains were separately averaged. The PAC-SYM questionnaire has shown good concurrent and clinical validity for opioid-induced constipation in a number of pain populations and has demonstrative responsiveness to treatment. There are three symptom domains within the PAC-SYM: Abdominal symptoms (4 items), rectal symptoms (3 items) and stool symptoms (5 items).

  Baseline and Day 7, after treatment completed (6 days of treatment)

• Change in Patient Assessment of Constipation - Quality of Life

  The second component of the PAC is the quality of life (QOL) component.The quality of life (QOL) component consists of five items that are rated on a 0-4 scale with higher scores indicating better QOL. Scores within the domains are averaged.

  Baseline and day 7

Study Arms (2)

Lubiprostone and placebo Senna

EXPERIMENTAL

Lubiprostone (Amitiza) 24 µg po BID given with meals for 6 days with two tabs placebo Senna at noon

Drug: Lubiprostone

Senna active plus Lubiprostone Placebo

ACTIVE COMPARATOR

Senna 2 tabs daily for 6 days at noon and placebo Lubiprostone 1 Cap BID

Drug: Senna

Interventions

Lubiprostone DRUG

24 µg po BID given with meals for 6 days

Also known as: Amitiza

Lubiprostone and placebo Senna

Senna DRUG

2 tabs daily for 6 days

Also known as: Sennasides 8.6 mg each tab

Senna active plus Lubiprostone Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult, 18 years old or greater.
• The patient is able to provide informed consent.
• Anticipated duration of hospitalization of at least 7 days.
• Use of opioid for post-op analgesia following orthopedic surgical procedures as defined as IV, IM, transdermal or PO opioid received within the prior 24 hours of hospitalization for pain control, and expectation that an opioid will be continued for pain control.
• Medication may be administered on a PRN (as needed) basis or scheduled basis
• One or greater doses has been received within the 24 hours prior to enrollment as determined by medication administration recorded from the acute care facility or RIC MAR.
• At least one associated symptom of constipation at the time of admission, such as, but not limited to:
• Lumpy or Hard stools
• Feeling of incomplete evacuation of bowels
• Abdominal cramping or pain
• Straining with movement of bowels or painful bowel movement effort
• Need for manual assistance to have a bowel movement

You may not qualify if:

• Known allergy or sensitivity to the study medications
• Females who are pregnant
• Diarrhea on the day of admission
• Diagnosis of Clostridium difficile infection during the current hospitalization
• Pre-existing medical condition or surgical procedure, which is known to commonly lead to bowel dysfunction such as, but not limited to:
• Crohn's disease
• Ulcerative colitis
• Multiple sclerosis
• Cerebral palsy
• Spinal Cord Injury
• Colectomy
• Malabsorption Syndrome
• Irritable Bowel Syndrome
• Abdominopelvic neoplasm (gastric, colon cancer)
• Severe liver disease

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead
• Takeda Pharmaceuticals North America, Inc.: collaborator

Study Sites (1)

Rehabilitation Institute of Chicago

Chicago, Illinois, 60302, United States

Location

Related Publications (1)

• 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.

  PMID: 25473191 DERIVED

MeSH Terms

Conditions

Constipation

Interventions

Lubiprostone; Sennosides

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alprostadil; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Senna Extract; Anthraquinones; Anthrones; Anthracenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Quinones; Polycyclic Compounds; Glycosides; Carbohydrates; Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures

Limitations and Caveats

Additional laxatives were frequently required for symptom control

Results Point of Contact

• Title: Christina Marciniak
• Organization: Rehabilitation Institute of Chicago

cmarciniak@ric.org

312-238-1000

Study Officials

• Christina M Marciniak, MD

  Shirley Ryan AbilityLab

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: April 16, 2008
• First Posted: April 21, 2008
• Study Start: April 1, 2008
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: March 6, 2013
• Results First Posted: February 21, 2013

Record last verified: 2013-02

Locations

US (1)