Opioid-induced Bowel Dysfunction MedDRA version: 14.0 Level: PT Classification code 10061247 Term: Intestinal functional disorder System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Trade Name: Amitiza
Product Name: Lubiprostone
Product Code: RU-0211
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: Lubiprostone
CAS Number: 136790-76-6
Current Sponsor code: RU-0211
Other de
Sponsors
Sucampo Pharma Americas, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range 32
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy and safety of oral lubiprostone at 48 mcg/day (24 mcg BID), as compared to placebo, when administered orally for 12 weeks to subjects with OBD.;Secondary Objective: N/A;Primary end point(s): The primary efficacy endpoint will be the overall SBM response rate. Responders, as defined in protocol Section 12.5.2, will be determined based on subjects' daily record of bowel movements. SBM is defined as any BM that does not occur within 24 hours after rescue medication use. To summarize, patients will be required to demonstrate at least moderate response (= 1 SBM improvement over baseline SBM frequency) for all treatment weeks for which observed data is available, and must additionally demonstrate a full response (= 3 SBMs per week) for at least 9 of the 12 treatment weeks, in order to be defined as a treatment responder. This primary efficacy endpoint is designed to demonstrate consistent and durable relief from OBD.;Timepoint(s) of evaluation of this end point: Overall SBM response rate during 12-week treatment period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Change from baseline in SBM frequency • First post-dose SBM (percentage of patients) • Responder rates • Mean changes from baseline in straining, stool consistency, constipation severity, abdominal bloating, abdominal discomfort, bowel habit regularity • Treatment effectiveness • Health related quality of life;Timepoint(s) of evaluation of this end point: Various timepoints specified for each secondary endpoint; generally assessed overall (over 12 weeks of treatment), unless otherwise specified. | — |
Countries
Belgium, Czech Republic, Germany, Poland, Sweden, United Kingdom, United States
Contacts
Public ContactProject Manager
Sucampo Pharmaceuticals, Inc.
Outcome results
None listed