NCT00446069

Brief Summary

The purpose of the study is to determine the effect of Egalet® Morphine once daily compared to MST Continus twice daily on pain intensity and use of rescue medication for break through pain after 2 weeks of treatment in patients with pain due to cancer.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at below P25 for phase_2 pain

Timeline
Completed

Started Aug 2007

Geographic Reach
2 countries

8 active sites

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

March 9, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 12, 2007

Completed
5 months until next milestone

Study Start

First participant enrolled

August 1, 2007

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

August 29, 2016

Status Verified

August 1, 2016

Enrollment Period

10 months

First QC Date

March 9, 2007

Last Update Submit

August 26, 2016

Conditions

PainCancer

Outcome Measures

Primary Outcomes (1)

  • Use of rescue medication

    2 weeks treatment

Secondary Outcomes (1)

  • Pain intensity

    2 weeks treatment

Study Arms (2)

Egalet® morphine

EXPERIMENTAL
Drug: Morphine Sulphate

MST Continus®

ACTIVE COMPARATOR
Drug: Morphine Sulphate

Interventions

Morphine SulphateDRUG

Egalet® morphine, Controlled Release 30 mg Oral tablet once daily for 2 weeks and MST Continus® 15 mg twice daily for 2 weeks

Egalet® morphineMST Continus®

Eligibility Criteria

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

You may qualify if:

  • The patient has stable strong opioid use equipotent to 30-240 mg oral morphine sulphate daily for a minimum of 2 weeks prior to entering the run-in phase.
  • The patient has opioid-sensitive pain caused by active cancer.
  • The patient is aged minimum 18 years.

You may not qualify if:

  • The patient has a life expectancy less than 2 months.
  • The patient has received chemotherapy or radiation therapy less than 4 weeks prior to entering run-in phase
  • Patients with medical conditions contraindicating morphine treatment
  • The patient has hepatic disease or impaired kidney function
  • The patient is taking monoamine oxidase inhibitors (MAOIs) or has taken a MAOI within two weeks prior to entering baseline.
  • The patient is taking other opioid agonists or antagonists, zidovudine or cimetidine.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Site 51

Kaunas, Lithuania

Location

Site 50

Vilnius, Lithuania

Location

Site 63

Bielsko-Biaia, Poland

Location

Site 60

Bydgoszcz, Poland

Location

Site 62

Poznan, Poland

Location

Site 61

Warsaw, Poland

Location

Site 64

Wroclaw, Poland

Location

Site 65

Włocławek, Poland

Location

MeSH Terms

Conditions

PainNeoplasms

Interventions

Morphine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Christine Andersen, MSc Pharm

    Egalet A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2007

First Posted

March 12, 2007

Study Start

August 1, 2007

Primary Completion

June 1, 2008

Study Completion

August 1, 2008

Last Updated

August 29, 2016

Record last verified: 2016-08

Locations

LI(2)PL(6)