NCT00412100

Brief Summary

The primary objective is to demonstrate that patients taking oxycodone/naloxone prolonged release tablets have improvement in symptoms of constipation compared to subjects taking oxycodone prolonged release tablets alone.

Trial Health

100
On Track

Trial Health Score

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

Timeline
Completed

Started Apr 2006

Typical duration for phase_3 pain

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 14, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 15, 2006

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

October 23, 2018

Status Verified

October 1, 2018

Enrollment Period

2.3 years

First QC Date

December 14, 2006

Last Update Submit

October 19, 2018

Conditions

Pain

Keywords

A randomiseddouble-blinddouble-dummyparallel-group multicentre study to demonstrate improvement in symptoms of constipationModerate to severe, chronic non-malignant pain

Outcome Measures

Primary Outcomes (1)

  • To demonstrate that subjects with moderate to severe non malignant pain taking oxycodone/naloxone prolonged release tablets have improvement in symptoms of constipation compared to subjects taking oxycodone prolonged release tablets alone.

    12 weeks with a 6 month open label extension

Interventions

Oxycodone naloxone prolonged release tablets (OXN)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female subjects at least 18 years or older with moderate to severe pain that requires around the clock opioid therapy. Subjects must report constipation caused or aggravated by opioids.

You may not qualify if:

  • Females who are pregnant or lactating.
  • Subjects with evidence of any clinically unstable disease or subjects with evidence of impaired liver/kidney function upon entry into the study.
  • Subjects with evidence of significant structural abnormalities of the gastrointestinal tract.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Lowenstein O, Leyendecker P, Lux EA, Blagden M, Simpson KH, Hopp M, Bosse B, Reimer K. Efficacy and safety of combined prolonged-release oxycodone and naloxone in the management of moderate/severe chronic non-malignant pain: results of a prospectively designed pooled analysis of two randomised, double-blind clinical trials. BMC Clin Pharmacol. 2010 Sep 29;10:12. doi: 10.1186/1472-6904-10-12.

    PMID: 20920236DERIVED

Related Links

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Oliver Lowenstein

    Private Practice

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2006

First Posted

December 15, 2006

Study Start

April 1, 2006

Primary Completion

July 1, 2008

Study Completion

September 1, 2008

Last Updated

October 23, 2018

Record last verified: 2018-10