NCT01812733

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 18, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

August 7, 2015

Status Verified

August 1, 2015

Enrollment Period

2 years

First QC Date

March 14, 2013

Last Update Submit

August 6, 2015

Conditions

PainOpioid Induced Constipation

Outcome Measures

Primary Outcomes (1)

  • Quality of Life

    Two visits performed over 8 weeks

    8 Weeks

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The patients have severe pain treated with opioids and will be enrolled at different clinics in Sweden

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rehabiliteringsmedicinska kliniken

Örebro, Sweden

Location

MeSH Terms

Conditions

PainOpioid-Induced Constipation

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsConstipationSigns and Symptoms, DigestiveNarcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2013

First Posted

March 18, 2013

Study Start

June 1, 2013

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

August 7, 2015

Record last verified: 2015-08

Locations

SE(1)