Opioid-induced Bowel Dysfunction
Conditions
Interventions
Product Name: alvimopan
Product Code: SB-767905
Pharmaceutical Form: Capsule*
CAS Number: 170098-38-1
Current Sponsor code: SB-767905
Other descriptive name: alvimopan
Concentration unit: mg milligram
Sponsors
GlaxoSmithKline R & D Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subject must be: ? Male or female 18 years or older at the time of the Screening Visit. ? Taking chronic opioid therapy for non-cancer related pain. The therapy must comprised of a full agonist opioid that is dosed chronically and administered orally, transdermally, intravenously, or subcutaneously, and dosed stably (+20% total daily dose and without any dose reductions) for at least one month prior to the Screening Visit at a minimum daily dose of at least 30 mg oral morphine equivalents ? Meet the protocol-definition of opioid-induced bowel dysfunction as follows: Since starting opioid therapy, a history based on subject recall of decreased BM frequency and at least one subjective BM symptoms (incomplete evacuation/hard stools/straining). To be randomized on Day 1 subjects must have a confirmed 2-week baseline history based on IVRS data of decreased BM frequency, occurrence of at least one of the subjective BM symptoms and compliance with the guidance for rescue laxative use. ? Female subjects must either be of non-child bearing potential, have a negative pregnancy test at screening and agree to use acceptable contraception throughout the study. ? Agree to all study procedure and sign and date the informed consent form. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subject will not be eligible for inclusion if; ? Subject is pregnant or lactating, or planning to become pregnant during the study. ? Subject is not ambulatory (e.g., bed or wheel chair bound). ? Subject has participated in another trial with an investigational drug, device or procedure within 30 days prior to the Screening Visit. Subject has been randomized to investigational product in this study (SB-767905/011) at anytime in the past. ? Subject is unable to eat or drink. Subjects who are unable to take oral medications or to hold down oral medications due to vomiting are excluded. ? Subject is taking opioids for cancer-related pain or for the management of drug addiction. ? Subject is unable or unwilling to discontinue the use of and/or refrain from using laxatives of all types and formulation other at the Screening Visit and throughout the entire study. Should a laxative regimen be needed, GlaxoSmithKline will provide the subject with a rescue laxative (oral bisacodyl tablets) for rescue use only throughout the entire study. ? Subject has severe constipation that has not been appropriately managed such that the subject is at immediate risk of developing serious complications of constipation. ? Subject with gastrointestinal or pelvic disorders known to affect bowel transit, produce GI obstruction, or contribute to bowel dysfunction. ? Subject, who in the investigators opinion, has bowel dysfunction that is predominantly resulting from causes other than the chronic use of opioids. ? Subject with chronic fecal incontinence. ? Subject, who in the investigators opinion, has an uncontrolled systemic disease that would contraindicate participation in this study. ? Subject has current evidence of, or has been treated for a malignancy within the past five years ? Subject has clinically significant laboratory abnormalities prior to Randomization ? Subject has a history of alcohol and/or substance abuse within the past 2 years. ? Subject is taking opioids that are mixed agonists/antagonists or partial agonists ? Subject has any other known condition or physical examination finding prior to Randomization, which could contraindicate participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To identify at least one orally-dosed alvimopan treatment regimen that improves spontaneous bowel movement (SBM) frequency compared to placebo while maintaining an acceptable tolerability profile.;Secondary Objective: ? To further compare the efficacy, including durability of the efficacy response, among treatment regimens ? To demonstrate the lack of effect of the treatment regimens on opioid analgesia ? To further compare the safety among the treatment regimens ? To describe the steady-state population pharmacokinetics of alvimopan and its main metabolite when alvimopan is dosed orally either once or twice daily ? To quantify the disease burden of OBD via the SF-36 and PAC-QOL ;Primary end point(s): The primary endpoint is the changes in weekly spontaneous bowel movement frequency during the first 3 weeks of the 6-week Treatment Period | — |
Countries
Denmark
Outcome results
None listed