Clinical trial: A Safety, Tolerability and Pharmacokinetic Dose Escalation Study of HC-ER in Patients With Osteoarthritis Pain (NCT02222740)

Eligibility criteria:
Inclusion Criteria:

          -  Subjects were 18 years or older

          -  Subjects had osteoarthritis (OA) defined by:

        Presence of of typical hip and/or knee joint symptoms. Involvement of at least 1 hip or
        knee joints that had warranted treatment with Non-Steroidal Anti-Inflammatory Drugs
        (NSAIDs), including cyclooxygenase-2 [COX-2] inhibitors and/or acetaminophen (APAP) for the
        last 3 months.

        Radiographic evidence within the last 6 months of OA in the index joint, with Grade II to
        IV severity, as illustrated by the Atlas of Standard Radiographs.

          -  Subjects were otherwise in generally good health, as determined by the investigator,
             on the basis of medical history, physical examination, electrocardiogram (ECG), and
             screening laboratory results.

          -  Female subjects were either physically incapable of childbearing or were practicing an
             acceptable method of birth control and had a negative pregnancy test result
             demonstrated before dosing.

          -  Subjects had experienced a suboptimal response to APAP and NSAID therapy (including
             COX-2 inhibitor).

          -  Subjects had used opioids for OA pain on an as needed (PRN) or occasional basis.

          -  Subjects were willing and able to discontinue or modify their current medication used
             for management of OA pain per protocol.

          -  Subjects had steady, not transient, pain and a categorical pain rating of moderate to
             severe on a scale of none, mild, moderate, or severe.

          -  Subjects weighed > or = to100 lbs.

          -  If a subject had taken any inducers or inhibitors of cytochrome P450 [CYP450j), these
             were discontinued and an appropriate washout period (5 half-lives) had occurred before
             entry in the study.

          -  Subjects were able to take oral medication and were willing to comply with the
             protocol.

          -  Subjects agreed to abstain from alcohol consumption for the duration of the study.

          -  Subjects were able to read, understand, and voluntarily sign the IRB approved consent
             document before the performance of any study-specific procedures.

        Exclusion Criteria:

          -  Subjects had any clinically significant condition that would, in the investigator's
             opinion, preclude study participation.

          -  Subjects had any other clinically significant form of disease at the index joint
             (study joint) or had been diagnosed with inflammatory arthritis, gout, pseudo-gout,
             Paget's disease, or any other chronic pain syndrome that, in the investigator's
             opinion, might interfere with the assessment of pain and other symptoms of OA.

          -  Subjects had known allergies or previous, significant reactions to opioids.

          -  Subjects had any laboratory abnormality at screening that was considered clinically
             significant by the investigator, or that, in the opinion of the investigator, would
             have contraindicated study participation.

          -  Subjects were known to have positive test results for human immunodeficiency virus
             (HIV), hepatitis B antigen, or hepatitis C antibody.

          -  Subjects had a history of chronic, scheduled opioid use for OA.

          -  Subjects had any signs or symptoms of opioid withdrawal.

          -  Subjects had a history of substance or alcohol abuse within 2 years before study
             entry.

          -  Subjects tested positively on a urine screen for drugs of abuse.

          -  Subjects had received any steroid therapy (e.g., oral, intramuscular, intravenous, or
             soft tissue) within 1 month of study entry.

          -  Subjects had a condition that would contraindicate the use of opioid analgesia.

          -  Subjects had participated in a study of an investigational drug or device, or had
             donated blood, within 30 days before study entry.

          -  Subjects used any medication that the investigator felt would interact unfavorably
             with the study medication (e.g., potentiation of sedation with tricyclic
             antidepressants).

          -  Subjects had used opioid analgesics for more than 3 days during the 30 days before
             screening.

          -  Subjects had a history of seizures.

          -  Subjects were considered by the investigator to be unsuitable for any reason.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee.

Patient description (patient's own words): I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee.

Does the patient match the trial criteria? Entailment