patients with chronic moderate to severe malignant pain which has not been adequately controlled by previous treatment with NSAIDs, COX-2 inhibitors or paracetamol. MedDRA version: 12.1 Level: LLT Classification code 10058019 Term: Cancer pain
Conditions
Interventions
Trade Name: JURNISTA*10CPR 4MG R.P.
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: Hydromorphone
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number:
Sponsors
JANSSEN-CILAG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Man or woman ≥ 18 ≤ 80 years of age. - Affected by malignancy and suffering from pain without clinical response to non-opiate drugs - Karnofsky Performance Status major or equal 50. - Presence of moderate-to-severe chronic pain defined as a score of at least 5 in the last 24 hours on a 11-point NRS, with inadequate response to treatment with non-opioid analgesics during the last 4-7 days - Medically stable on the basis of physical examination, medical history and vital signs performed at screening/baseline. If there are abnormalities, they must be consistent with the underlying illness in the study population. - Women must be: Urinary pregnancy test-negative postmenopausal (for at least 2 years) or surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy) or abstinent or - if sexually active, be practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive patch, intrauterine device, double-barrier method, male partner sterilization), before the start and throughout the study. - Willing/able to adhere to the prohibitions and restrictions specified in this protocol. - Patients must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study. Men must agree to use a double barrier method of birth control and to not donate sperm during the study and for 3 months. 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: - Exclusively or prevalently neuropathic pain or pain of unknown origin (without a clearly identifiable cause). - Pain present only upon movement. - Current or recent (within 6 months) history of drug and/or alcohol abuse. - Women are pregnant or lactating and women of childbearing potential who, are seeking pregnancy, or failing to take adequate contraceptive precautions. - Known allergies, hypersensitivity, or intolerance to hydromorphone or its excipients. Galactose intolerance, including Lapp-lactase deficit and glucose-galactose malabsorption syndrome. - Presence of GI disease of sufficient severity to likely interfere with oral analgesia (e.g., dysphagia, vomiting, no bowel movement or bowel obstruction due to impaction within 5 days of study entry, severe gut narrowing that may affect analgesic absorption or transit). - Illnesses of the CNS including head trauma, increase of intracranial pressure, stroke within 6 months prior to study start. - Major clinical depression and cognitive disorders (according to DSM IV criteria) - Presence of risk factors for a severe blood pressure decrease under use of opioid analgesics (i.e. blood volume depletion, vasomotor depression, circulatory shock). - Severe respiratory depression. - History of liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances. - Other conditions for which risks of opioid use outweigh potential benefits (e.g., hypotension, hypothyroidism, asthma, reduced respiratory reserve, prostate hypertrophy, liver impairment, renal impairment, elderly and debilitated, convulsive disorders, Addison s disease). - Radiotherapy, surgical intervention on the CNS, antalgic invasive procedures during the last 4 weeks. - Changes of the chemotherapy regimen during the last 4 weeks. - Concomitant use of monoamine oxidase inhibitors. - Need for other opioid analgesics (except study medication and breakthrough pain medication). - Current use, or history of previous treatment with weak or strong opioids, including buprenorphine, nalbufine or pentazocine. - Current use of phenotiazines or general anesthetic agents. - Received an investigational drug or used an investigational medical device within 30 days before the planned start of treatment or are currently enrolled in an investigational study. - Any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patients from meeting or performing study requirements. - Employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the overall safety and tolerability of OROS hydromorphone treatment, starting with a low dose (4 mg) in opioid na?ve patients with cancer pain severe enough to require continuous opioid therapy. This will be assessed by measurement of physical examination, vital signs and continuous monitoring of opioid-related adverse events (AEs) and concomitant medication.;Secondary Objective: - To assess the drop-out rate due to side effects - To document the efficacy of OROS hydromorphone in opioid na?ve cancer patients through: Time to first titration Pain control using NRS (Numerical Rating Scale) score Total amount of study drug intake Rescue medication intake - To assess patient satisfaction on mode and convenience of drug intake - To assess the effect of treatment on patients sleep - To assess the effect of treatment on patients quality of life;Primary end point(s): due to the nature of the study no formal statistical hypotheses are tested and the statistical test will have descriptive meaning. The primary objective is to evaluate the overall safety and tolerability of OROS hydromorphone treatment, starting with a low dose (4 mg) in opioid na?ve patients with cancer pain severe enough to require continuous opioid therapy. This will be assessed by measurement of physical examination, vital signs, and continuous monitoring of adverse events (AEs) and concomitant medication. | — |
Countries
Italy
Outcome results
None listed