Non-interventional Study Comparing Targiniq and Oxycodone/Laxatives

Mundipharma

Status: Completed

Conditions: Opioid Induced Constipation; Pain

Study type: Observational

Funder types: Industry

Identifiers

NCT01812733

OXN9513

Details and patient eligibility

About

The objective of the non-interventional study is to compare the quality of life, health care resource use and costs between the use of a combination of oxycodone and naloxone (Targiniq) versus oxycodone and laxatives for patients with severe pain, and to evaluate the cost-effectiveness of treatment with Targiniq.

Enrollment: 37 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or non-pregnant female ≥18 years of age
• Malignant or non-malignant opioid sensitive pain
• Must sign an informed consent form (ICF)
• Must have a stable daily dose of oxycodone prolonged release formulation titrated to analgesic effect (as to be assessed by clinical experts)
• Use of laxatives for concomitant opioid-induced constipation in an adequate dose and length of time and without sufficient effect
• BFI ≥30 and state a discomfort caused by the constipation at screening
• Ability to answer the patient questionnaires and have an estimated overall life expectancy of at least six (6) months

Exclusion criteria

• History of, or on-going, abuse of alcohol and/or drugs
• Inability to read and understand written instructions, ICF or questionnaires
• Constipation not related to opioid use
• Unsuitable patient for other reason(s) in the opinion of the investigator
• Inpatients, if admission and/or discharge is expected during study period