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Completed

NCT Number: NCT01812733

Non-interventional Study Comparing Targiniq and Oxycodone/Laxatives

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.

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Key information

Conditions

Pain Chemically-Induced Disorders Constipation Mental Disorders Narcotic-Related Disorders Neurologic Manifestations Opioid Induced Constipation Opioid-Induced Constipation Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rehabiliteringsmedicinska kliniken

Örebro, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Quality of Life

    Time frame: 8 Weeks

    Two visits performed over 8 weeks

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Sponsors and collaborators

Lead sponsor

Mundipharma AB

Industry

Registry information

Official study title

An Observational Study of Quality of Life, Resource Use and Costs Associated With Treatment of Severe Pain - a Comparison of a Combination of Oxycodone and Naloxone (Targiniq) Versus Oxycodone and Laxatives

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Mar 18, 2013
Registry last updated
Aug 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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