Effectiveness and Safety of Lubiprostone for Treatment of Opioid-induced Bowel Dysfunctio

• Conditions: Opioid-induced Bowel Dysfunction; MedDRA version: 14.0Level: PTClassification code 10061247Term: Intestinal functional disorderSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2010-022991-29-SE
• Lead Sponsor: Sucampo Pharma Americas, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-20
• Last Update Posted: 2 October 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 420

Inclusion Criteria

1. Subject is =18 years of age.
2. Subject has been treated consistently for chronic, non-cancer-related pain with any oral, transdermal, intravenous or subcutaneous opioid (full agonist) other than methadone for at least 30 days prior to screening, and will continue opioid therapy throughout the study.
3. Subject must have OBD, which is defined as having an average of <3 spontaneous bowel movements (SBMs) per week during the screening period (with spontaneous” defined as bowel movements [BMs] occurring without the use of laxatives/stool softeners) and at least one of the following for at least 25% of SBMs during each week of the screening period (as reported in the daily diary) :
• Hard or very hard stools;
• Sensation of incomplete evacuation; and/or
• Moderate to very severe straining associated with SBMs.
4. If subject has a history of chronic constipation (= 90 days), condition of constipation must have been exacerbated by the initiation of opioid treatment.
5. If subject is taking concomitant medication (prescribed or over-the-counter) that affects gastrointestinal motility (other than opioid therapy), he/she must discontinue use from the Screening Visit through the completion of the study; these medications include:
• Anticholinergics*, anti-spasmodics, cholinesterase inhibitors, anti-diarrhea, anti-constipation, or prokinetic agents;
• Laxative agents, including homeopathic remedies;
• Tricyclic antidepressants; and
• Any medications at the discretion of the Investigator known to relieve or cause constipation, bloating, or other constipation-related symptoms.
6. If subject has confirmed diagnosis of clinical depression and he/she has been treated with SSRIs, SNRIs, or MAO inhibitors, treatment must have been at a stable dose for at least 30 days prior to the Screening Visit and not likely to change during the study.
7. Subject is willing to discontinue use of laxative and stool softeners from the Screening Visit through the completion of the study (use of approved rescue laxatives will be allowed under certain protocol-specified circumstances).
8. If subject is taking a fiber supplement, usage must have been at a stable dose and schedule for at least 30 days prior to the Screening Visit and not likely to change during the study.
9. Subject must be willing and able to fill out his/her own electronic diary and can comply with daily data collection.
10. Subject daily diary is at least 70% compliant for the screening period.
11. Subject is capable of making an informed decision, and has read, understood, and signed the approved Informed Consent Form.

*Except ipratropium bromide or any inhaled or nasal-spray forms of this medication.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 388
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 32

Exclusion Criteria

1. Subject is receiving opioid therapy for cancer-related pain, abdominal pain, scleroderma, and/or for the management of drug addiction.
2. Subject is receiving methadone, methadone HCl, or a congener of methadone either alone or as part of opioid regimen.
3. Subject has current evidence of, or has been treated for, cancer within the past 5 years (with the exception of localized basal cell, squamous cell skin cancer, or in situ cancer that has been resected).
4. Subject has adjusted (increased or decreased by +/-30%) dosage (in MEDD) of opioid treatment, has changed
opioid agents, or has changed route of opioid administration within 30 days of screening, or is likely to
discontinue or adjust dosage by +/-30% over the course of the study.
5. Subject has known or suspected anatomic or organic disorders of the large or small bowel; e.g.:
• Associated with a mechanical bowel obstruction (e.g., tumor, hernia, obstructive polyps), or pseudoobstruction;
• Associated with large or small bowel disorder such as ulcerative colitis or Crohn’s disease.
6. Subject has constipation that, according to the Investigator’s clinical judgment, is not the result of or not
exacerbated by opioid use, or is suffering from known or suspected secondary cause of constipation, including but not limited to: dietary disorders (e.g., malnutrition), neurologic disorders (e.g., spinal cord disorders), other congenital disorder, or endocrine disorders (e.g., hypothyroidism or diabetes).
7. Subject has impaired renal function identified at the Screening Visit (i.e., serum creatinine concentration > 1.8 mg/dL).
8. Subject has experienced an unexplained, clinically significant weight loss defined as > 5% weight loss within 90 days prior to the Screening Visit.
9. Subject has undergone a gastrointestinal or abdominal surgical procedure within 90 days prior to the Screening Visit, or has had a bowel resection at any time.
10. Subject is non-ambulatory.
11. Subject is unable to eat or drink, take oral medications, or to hold down oral medications due to vomiting.
12. Female subject of childbearing potential is unable or unwilling to use a protocol-specified method of birth control.
13. Female subject of childbearing potential has a positive screening pregnancy test, is currently pregnant or nursing, or plans to become pregnant or nurse during the clinical study.
14. According to Investigator’s clinical judgment, subject has clinically significant cardiovascular disease.
15. According to Investigator’s clinical judgment, subject has clinically significant, unexplained liver or lung disease, neurologic or psychiatric disorders (excluding depression), or any other systemic disease. If explained, the subject may be enrolled, if in the Investigator’s opinion, the condition would not interfere with safety or efficacy assessments, or result in an increased risk of participation to the subject.
16. Subject has a history of alcohol or drug abuse within 180 days prior to Screening Visit.
17. Subject demonstrates a potential for non-compliance with the study protocol (i.e., dosing schedule, visit schedule, diary completion, or study procedures).
18. Subject has participated in another study with an investigational drug, device, or procedure within the 30 days preceding the Screening Visit.
19. Subject has received AMITIZA®, lubiprostone, SPI-0211, or RU-0211 at any time prior to participation in this study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified