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

Primary Purpose

Constipation

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Lubiprostone

Senna

About this trial

This is an interventional treatment trial for Constipation focused on measuring constipation, opioid, rehabilitation, post-operative, orthopedic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Adult, 18 years old or greater.
The patient is able to provide informed consent.
Anticipated duration of hospitalization of at least 7 days.
Woman of childbearing potential must have a negative serum pregnancy test at enrollment. Exclusions for testing include two years or greater postmenopausal, hysterectomy or tubal ligation.
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

Exclusion Criteria:

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
- Colonic or ileo-colonic resections

Sites / Locations

Rehabilitation Institute of Chicago

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lubiprostone and placebo Senna

Senna active plus Lubiprostone Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00662363

First Posted

April 16, 2008

Last Updated

February 27, 2013

Sponsor

Shirley Ryan AbilityLab

Collaborators

Takeda Pharmaceuticals North America, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00662363

Brief Title

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

Official Title

Lubiprostone (Amitiza®) Compared to Standard Care in the Treatment of Postoperative Opioid-induced Constipation in Inpatient Rehabilitation Patients Following Orthopedic Procedures

Study Type

Interventional

2. Study Status

Record Verification Date

February 2013

Overall Recruitment Status

Completed

Study Start Date

April 2008 (undefined)

Primary Completion Date

October 2011 (Actual)

Study Completion Date

October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shirley Ryan AbilityLab

Collaborators

Takeda Pharmaceuticals North America, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

The purpose of this study is to assess the efficacy of Lubiprostone (Amitiza) compared to standard care for the treatment of constipation in orthopedic patients receiving opioids for pain control during inpatient rehabilitation. Lubiprostone (Amitiza®) is a locally acting chloride channel activator that increases intestinal fluid, and thus increases intestinal motility. It has been approved for chronic constipation, but not in the setting of opioid-induced constipation. Senna is a stimulant laxative that increases propulsive peristaltic activity of the colon through local effects on the mucosa. Subjects will be compared using from the Patient Assessment of Constipation (PAC) which has previously been found to be a valid and reliable way to measure constipation symptoms and clinical course. (Frank, Kleinman et al. 1999) as well as with other measures of bowel-related symptoms and functional outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Constipation

Keywords

constipation, opioid, rehabilitation, post-operative, orthopedic

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

64 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lubiprostone and placebo Senna

Arm Type

Experimental

Arm Description

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

Arm Title

Senna active plus Lubiprostone Placebo

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Lubiprostone

Other Intervention Name(s)

Amitiza

Intervention Description

24 µg po BID given with meals for 6 days

Intervention Type

Drug

Intervention Name(s)

Senna

Other Intervention Name(s)

Sennasides 8.6 mg each tab

Intervention Description

2 tabs daily for 6 days

Primary Outcome Measure Information:

Title

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

Description

Time Frame

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

Title

Change in Patient Assessment of Constipation - Quality of Life

Description

Time Frame

Baseline and day 7

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adult, 18 years old or greater. The patient is able to provide informed consent. Anticipated duration of hospitalization of at least 7 days. Woman of childbearing potential must have a negative serum pregnancy test at enrollment. Exclusions for testing include two years or greater postmenopausal, hysterectomy or tubal ligation. 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 Exclusion Criteria: 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 Colonic or ileo-colonic resections

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christina M Marciniak, MD

Organizational Affiliation

Shirley Ryan AbilityLab

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rehabilitation Institute of Chicago

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60302

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

25473191

Citation

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.

Results Reference

derived

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

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