Opioid induced gastrointestinal dysfunction MedDRA version: 20.1 Level: LLT Classification code 10013225 Term: Disorder gastrointestinal System Organ Class: 100000004856 MedDRA version: 20.1 Level: LLT Classification code 10079385 Term: Opioid use disorder System Organ Class: 100000004873
Conditions
Interventions
Trade Name: Moventig
Product Name: Moventig
Pharmaceutical Form: Tablet
INN or Proposed INN: Naloxegol
CAS Number: 854601-70-0
Other descriptive name: NALOXEGOL
Concentration unit: mg milligram(s)
Con
Sponsors
UZLeuven
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient is a man or woman aged 18 to 65 years, inclusive, at screening. 2. Patient who started opioid treatment and is on a stable dose for the last 4 weeks 3. Patient experiencing opioid induced constipation. 4. Patient is experiencing upper gastrointestinal symptoms beside opioid induced constipation with an average composite GCSI-DD score of =2 during the 14 days before randomization. 5. Medications taken for the treatment of allergies, chronic medical conditions, and migraine headaches can be taken during this study. Patients on a stable dose of one antidepressant for at least 3 months will be allowed to participate in the study. Habitual use of benzodiazepines is permitted. 6. Female subjects must either be: a. postmenopausal, defined as 52 years or older and amenorrheic for at least 2 years at screening, b. surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), c. abstinent, or d. if sexually active, be practicing an effective method of birth control such as hormonal prescription oral contraceptives, progesterone implants or injections, contraceptive patch, intrauterine device, or male partner with a vasectomy. 7. Patient must sign an informed consent document before the initiation of any study-related procedures indicating that he or she understands the purpose and procedures required for the study and is willing to participate in the study. 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 45 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: 1. Patient has a history of inflammatory or immune-mediated GI disorders including inflammatory bowel disease (ie, Crohn’s disease, ulcerative colitis), celiac disease and functional bowel disorder. 2. Patient has a history of diverticulitis. 3. Patient has a history of intestinal obstruction, stricture, toxic megacolon, GI perforation, gastric banding, bariatric surgery, adhesions, ischemic colitis, or impaired intestinal circulation (eg, aortoiliac disease). 4. Patient has any of the following surgical history: a. Any abdominal surgery within the 3 months prior to screening; b. Subject has a history of major gastric, hepatic, pancreatic, or intestinal surgery (appendectomy, hemorrhoidectomy, or polypectomy more than 3 months post-surgery are allowed). 8. Patient takes or is required to take prohibited medication (see section 4.3) 9. Patient has a history of a cardiovascular event, including stroke, myocardial infarction, congestive heart failure, or transient ischemic attack within 6 months prior to screening. 10. Patient has an unstable renal, hepatic, metabolic, or hematologic condition. 11. Patient has a history of malignancy within 5 years before screening (except squamous and basal cell carcinomas and cervical carcinoma in situ). 12. Patient has abnormal thyroid function test as confirmed by thyroid-stimulating hormone <0.3 mcIU/mL or =5 mcIU/mL at screening. However, patients who are clinically euthyroid due to thyroid supplement are candidates for the study. 13. Patient has received an investigational drug or used an investigational medical device within 14 days prior to screening, or is currently enrolled in an investigational study. 14. Patient is pregnant or breastfeeding. 15. Patient has any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study the effect of Naloxegol on upper gastrointestinal symptoms in patients with opioid-induced constipation, assessed by the GCSI-DD;Secondary Objective: To study the effect of Naloxegol on gastric emptying rate in patients with opioid-induced constipation;Primary end point(s): -GCSI-DD improvement ;Timepoint(s) of evaluation of this end point: End point will be evaluated at the end of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Gastric emptying according to the octanoic acid breath test (solids & liquids) – gastric emptying and associated symptoms will be evaluated (9) - PAGI-SYM/QOL - PAC-SYM/QOL - Leuven gastroparesis scale/diary - Bristol stool scale - Radio-opaque marker study to evaluate gastrointestinal transit/colonic transit in hours - Overall Treatment Evaluation (OTE) for nausea and other gastric symptoms;Timepoint(s) of evaluation of this end point: All end points will be evaluated at the end of the study. | — |
Countries
Belgium
Contacts
Public ContactLieselot Holvoet
UZLeuven
Outcome results
None listed