An open label, prospective, multicenter, single-arm clinical trial to investigate the safety and the analgesic effectiveness of a low dose (4 mg) OROS hydromorphone hydrochloride as starting dose in opioid-na?ve patients with cancer pain - ND

• Conditions: 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: 12.1Level: LLTClassification code 10058019Term: Cancer pain

• Registration Number: EUCTR2009-015931-33-IT
• Lead Sponsor: JANSSEN-CILAG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05-14
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified