NCT02321397

Brief Summary

This study is aimed to demonstrate equivalence between combinations of lower strength OXN PR tablets (OXN PR LST) and single higher strength OXN PR tablets (OXN PR HST) taken at the same overall daily dose.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
155

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2014

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2014

Completed
19 days until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 22, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

November 4, 2016

Status Verified

December 1, 2015

Enrollment Period

1.3 years

First QC Date

October 13, 2014

Last Update Submit

November 3, 2016

Conditions

Malignant PainNon-malignant Pain

Keywords

oxycodone naloxone combinationsevere chronic and non-malignant painMalignant and non-malignant pain that requires around-the clock opioid therapy

Outcome Measures

Primary Outcomes (2)

  • (mean of subjects average pain over the last 24 hours as assessed by the pain intensity scale.)

    Pain scores based on the mean of subjects average pain over the last 24 hours as assessed by the pain intensity scale. To demonstrate equivalence between multiple lower strength OXN PR tablets and a single higher strength OXN PR tablet taken at the same overall total daily dose

    24 hours at one day in week 2, 3 5 and 6 from date of randomisation.

  • Equivalent bowel function as assessed by the Bowel Function Index (BFI).

    Week 2, 3 5 and 6 from date of randomisation.

Secondary Outcomes (5)

  • Pain scores of subjects average pain over the last 24 hours and rescue medication use.

    Week 1,2,3,4,5 and 6 from date of randomisation

  • To assess bowel function (assess BFI and laxative use)

    Week 1,2,3,4,5 and 6 from date of randomisation

  • To assess quality of life based on the EuroQol EQ-5D.

    Visit 3 and visit 6 from date of randomisation

  • Number of participants with adverse events, high/low laboratory values and clinically significant ECG findings.

    Up to 35 weeks

  • Pain right now scores at intake of oxycodone/naloxone tablets.

    Week 2,3,5 and 6 from date of randomisation

Study Arms (2)

OXN PR HST

EXPERIMENTAL

Prolonged release oxycodone/naloxone higher strength tablets

Drug: Oxycodone

OXN PR LST

ACTIVE COMPARATOR

Prolonged release oxycodone/naloxone lower strength tablets

Drug: Naloxone

Interventions

OxycodoneDRUG
OXN PR HST
NaloxoneDRUG

Prolonged Release Tablets

OXN PR LST

Eligibility Criteria

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

You may qualify if:

  • Subjects who are receiving WHO step III opioid analgesic medication for the treatment of non-malignant or malignant pain.
  • Documented history of non-malignant or malignant pain that requires around-the-clock opioid therapy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Mainz, Germany

Location

MeSH Terms

Conditions

Bronchiolitis Obliterans Syndrome

Interventions

OxycodoneNaloxone

Condition Hierarchy (Ancestors)

Organizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseImmune System Diseases

Intervention Hierarchy (Ancestors)

CodeineMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2014

First Posted

December 22, 2014

Study Start

November 1, 2014

Primary Completion

March 1, 2016

Study Completion

September 1, 2016

Last Updated

November 4, 2016

Record last verified: 2015-12

Locations

DE(1)