An Open-Label Study to Evaluate the Long-term Safety of Subcutaneous MOA-728 forTreatment of Opioid-Induced Constipation in Subjects With Nonmalignant PainEstudio abierto para evaluar la seguridad a largo plazo de MOA-728 subcutánea para el tratamiento del estreñimiento inducido por opiáceos en sujetos con dolor de origen no maligno
- Conditions
- Opioid-induced constipation in subjects with non-malignant painTratamiento del estreñimiento inducido por opiáceos en sujetos con dolor de origen no malignoMedDRA version: 9.1Level: LLTClassification code 10010774Term: Constipation
- Registration Number
- EUCTR2008-005935-14-ES
- Lead Sponsor
- Wyeth Research Division of Wyeth Pharmaceuticals Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 800
1. Male or female subjects aged 18 years or older.
2. A history of pain of at least 2 months? duration before the screening visit due to a documented underlying nonmalignant condition.
3. Stable medical status for at least 1 month before the screening visit.
4. Taking oral, transdermal, intravenous, or subcutaneous opioids daily for at least 1 month, with anticipated continuing daily opioid therapy for the duration of the study.
5. A history of constipation due to opioid use during the 1 month before the screening visit. Subjects must satisfy 2 or more of the following criteria during the month prior to the screening visit to be eligible:
a. Hard or lumpy stools for at least 25% of the bowel movements.
b. Straining during at least 25% of the bowel movements.
c. A sensation of incomplete evacuation after at least 25% of the bowel movements.
d. Use of manual maneuvers (eg, digital evacuation, support of pelvic floor) to facilitate bowel movements at least 25% of the time.
e. Fewer than 3 bowel movements per week.
6. At least 1 bowel movement in the week prior to the screening visit.
7. All female and male subjects who are biologically capable of having children must agree and commit to the use of a reliable method of birth control for the duration of the study and for 15 days after the last dose of test article. A subject is biologically capable of having children if he or she is using contraceptives or if his or her sexual partner is sterile or using contraceptives.
8. Willingness and ability to participate in all aspects of the study, including use of
subcutaneous medication (administered by self or designee), completion of
subject evaluations, attending scheduled clinic visits, and compliance with all protocol
requirements as evidenced by written informed consent.
9. Ambulatory, capable of all self care and up and about more than 50% of waking hours.
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
1. Received any investigational drugs or devices other than MOA-728 within 4 weeks
before administration of the first dose of test article.
2. Pregnant, breastfeeding, or plans to become pregnant during the study.
3. A diagnosis of bowel obstruction, fecal incontinence, rectal prolapse, or other significant GI disorders.
4. A history of active inflammatory bowel disease, irritable bowel syndrome, or megacolon within 6 months before the screening visit.
5. A history of rectal bleeding unexplained by hemorrhoids or fissures.
6. Clinical evidence of outlet obstruction or impaction.
7. A history of malignancy, other than basal cell or squamous cell skin carcinoma, within 5 years before the screening visit.
8. A history of chronic constipation before the initiation of opioid therapy.
9. A history of alcohol or drug abuse within 1 year before the screening visit.
10. Any unstable hepatic, renal, pulmonary, cardiovascular (including uncontrolled
hypertension), ophthalmologic, neurologic, psychiatric, or any other medical condition
that might compromise the study or put the subject at greater risk during study
participation.
11. A history or presence of symptomatic orthostatic hypotension.
12. Other clinically important abnormalities on the screening physical examination,
electrocardiogram (ECG), or laboratory tests.
13. A calculated creatinine clearance (Cockcroft-Gault glomerular filtration rate [GFR])
<30 mL/min.
14. Urine drug screen positive for a substance of abuse that is not explained by a prescribed medication reported by the subject.
15. Planned surgery during the study.
16. Known or suspected allergy or other contraindication to opioids, opioid derivatives, or opioid antagonists (eg, codeine, naltrexone, or naloxone).
17. Current treatment with partial opioid agonists (eg, buprenorphine) or combination agonists/antagonists.
18. Involvement in current litigation related to the subject's underlying medical condition.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Primary: The primary objective of the study is to evaluate the long-term safety and tolerability of the subcutaneous formulation of MOA-728 in subjects with opioid-induced constipation who have nonmalignant pain.;Secondary Objective: Secondary: The secondary objective of the study is to assess the long-term efficacy of the subcutaneous formulation of MOA-728 in subjects with opioid-induced constipation who have nonmalignant pain.;Primary end point(s): Safety and tolerability will be evaluated by collection of adverse events, laboratory assessments, physical examinations, vital signs measurements, electrocardiograms, Pain Intensity Scale, and the opioid withdrawal scales.
- Secondary Outcome Measures
Name Time Method