An interventional study of Lubiprostone and Senna in Constipation, sponsored by Shirley Ryan AbilityLab. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-03-06.
Sponsored by Shirley Ryan AbilityLab · Not applicable, Interventional, and Treatment
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.
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.
1,018 studies on the registry are indexed under Constipation; 139 are open to participants now.
This study's enrollment of 64 is below the median of 80 across 850 interventional studies indexed under Constipation.
Browse Constipation studies →Shirley Ryan AbilityLab is the lead sponsor of 177 studies on the registry; 43 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 4 (40%) have results posted.
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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.
At least one associated symptom of constipation at the time of admission, such as, but not limited to:
Exclusion Criteria:
Pre-existing medical condition or surgical procedure, which is known to commonly lead to bowel dysfunction such as, but not limited to:
Lubiprostone (Amitiza) 24 µg po BID given with meals for 6 days with two tabs placebo Senna at noon
Drug: Lubiprostone
Senna 2 tabs daily for 6 days at noon and placebo Lubiprostone 1 Cap BID
Drug: Senna
24 µg po BID given with meals for 6 days
Also known as: Amitiza
2 tabs daily for 6 days
Also known as: Sennasides 8.6 mg each tab
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).
Time frame: 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.
Time frame: Baseline and day 7
Participants were recruited from the inpatient population of an academic freestanding rehabilitation hospital following admission for impairments related to an orthopedic surgery.The study was approved by the local institutional review board and all subjects provided written informed consent.
| Milestone | Lubiprostone | Senna |
|---|---|---|
| Started | 32 | 32 |
| Completed | 21 | 22 |
| Not completed | 11 | 10 |
| Withdrew: Withdrawal by subject | 6 | 5 |
| Withdrew: Adverse event | 0 | 3 |
| Withdrew: Discharged early from rehab | 4 | 1 |
| Withdrew: Protocol violation | 1 | 1 |
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).
| units on a scale | Lubiprostone | Senna |
|---|---|---|
| Change in Patient Assessment of Constipation (PAC) - Symptoms (Sym) | -0.22 ± 0.57 | -0.29 ± 0.58 |
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.
| units on a scale | Lubiprostone | Senna |
|---|---|---|
| Change in Patient Assessment of Constipation - Quality of Life | 0.99 ± 0.78 | .42 ± 0.84 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Lubiprostone | — | 1/31 (3.2%) | 13/31 (41.9%) |
| Senna | — | 1/29 (3.4%) | 11/29 (37.9%) |
| Event | Lubiprostone | Senna |
|---|---|---|
| CardiomyopathyCardiac disorders | 0/31 | 1/29 |
| patellar dislocationMusculoskeletal and connective tissue disorders | 1/31 | 0/29 |
| Event | Lubiprostone | Senna |
|---|---|---|
| Gastrointestinal DisorderGastrointestinal disorders | 13/31 | 8/29 |
| HeadacheNervous system disorders | 0/31 | 1/29 |
| RashSkin and subcutaneous tissue disorders | 0/31 | 1/29 |
| Increased INRBlood and lymphatic system disorders | 0/31 | 1/29 |
| Age, Categorical(Participants) | Lubiprostone | Senna | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 9 | 7 | 16 |
| >=65 years | 23 | 25 | 48 |
| Age Continuous(years) | Lubiprostone | Senna | Total |
|---|---|---|---|
| Mean | 70.9 ± 11.8 | 72.2 ± 10.5 | 71.6 ± 11.5 |
| Sex: Female, Male(Participants) | Lubiprostone | Senna | Total |
|---|---|---|---|
| Female | 22 | 17 | 39 |
| Male | 10 | 15 | 25 |
| Region of Enrollment(participants) | Lubiprostone | Senna | Total |
|---|---|---|---|
| United States | 32 | 32 | 64 |
This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.
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