Phase 3
Completed N=395
Safety Study of Oxycodone Hydrochloride and Naltrexone Hydrochloride Extended-Release Capsules in Subjects With Moderate to Severe Chronic Noncancer Pain
Chronic Noncancer Pain
Source: ClinicalTrials.gov NCT01428583 ↗
Enrolled (actual)
395
Serious AEs
6.6%
Results posted
Nov 2016
Primary outcomePrimary: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Adverse Reactions — 343; 207 participants
◆ Published Evidence
Emerging
14citations · ~1 / year
A multicenter, 12-month, open-label, single-arm safety study of oxycodone-hydrochloride/naltrexone-hydrochloride extended-release capsules (ALO-02) in patients with moderate-to-severe chronic noncancer pain.
Summary
The study will provide information to assess the benefits versus risks of extended exposure to oxycodone HCl and naltrexone HCl extended-release capsules in a chronic noncancer pain population.
Linked Publications (3)
-
A multicenter, 12-month, open-label, single-arm safety study of oxycodone-hydrochloride/naltrexone-hydrochloride extended-release capsules (ALO-02) in patients with moderate-to-severe chronic noncancer pain.
-
Effects of naltrexone exposure observed in two phase three studies with ALO-02, an extended-release oxycodone surrounding sequestered naltrexone.
-
Safety and tolerability of ALO-02 (oxycodone hydrochloride and sequestered naltrexone hydrochloride) extended-release capsules in older patients: a pooled analysis of two clinical trials.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (AEs) and Adverse Reactions |
343; 207 | — |
| SECONDARY Number of Participants With Treatment Emergent (TE) Adverse Events (AEs) Based on Intensity |
94; 202; 47 | — |
| SECONDARY Percentage of Participants With Clinical Opiate Withdrawal Scale (COWS) Score |
13.2; 0.0; 0.3; 0.0 | — |
| SECONDARY Subjective Opiate Withdrawal Scale (SOWS) Score |
5.4; 4.6; 3.6; 3.6; 3.3; 2.9 | — |
Eligibility Criteria
Inclusion Criteria
- Subject has moderate to severe chronic noncancer pain (duration of at least 3 months) requiring a continuous around-the-clock opioid analgesic for an extended period of time. Conditions may include, but are not limited to, osteoarthritis, chronic low back pain, or other opioid -responsive pain conditions.
- Subject agrees to refrain from taking opioid medications other than study drug during the study. (The exception is during the Pre-Treatment Period when the subject may continue current opioid therapy to guide first 4 weeks of the Treatment Period when the subject may administer immediate-release oxycodone to support conversion to study drug.)
Exclusion Criteria
- Subject has moderate or severe chronic pain due to cancer, migraine, recent trauma, infection, or other pain expected to be short-term (duration less than 3 months).
- Subject has a documented history of alcohol or drug abuse within 1 year prior to study entry that in the Investigator's judgment would impact subject participation.
- Subject has ongoing or active alcohol or drug abuse that in the Investigator's judgment would impact subject participation.
- Subject has a positive urine drug test for illicit drug use or medications at screening without legitimate medical explanation.
- Subject has a clinically significant medical condition (e.g., cardiovascular, neurological, renal, hepatic, pulmonary, gastrointestinal, endocrine, hematological, immunological, rheumatological, metabolic, or psychiatric) or physical examination, vital signs (VS), 12-lead electrocardiogram (ECG), clinical laboratory abnormalities that in the opinion of the Investigator would impact the safety of the subject during study participation.
- If female, the subject is pregnant or breast-feeding.
- Subject has a known history or known hypersensitivity to oxycodone, oxycodone salts, naltrexone or acetaminophen,or pharmacological similar compounds.
- Subject is historically non-responsive to oxycodone treatment or requires greater than 160 mg oxycodone in a 24-hour time interval.
Data sourced from ClinicalTrials.gov (NCT01428583) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.