NCT00125801

Brief Summary

The purpose of this study is to see whether injection of hydromorphone through a subcutaneous injection device is more effective in treating breakthrough cancer pain than oral morphine.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2005

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

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

August 1, 2005

Completed
Same day until next milestone

Study Start

First participant enrolled

August 1, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 2, 2005

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

October 15, 2008

Status Verified

October 1, 2008

Enrollment Period

2.8 years

First QC Date

August 1, 2005

Last Update Submit

October 13, 2008

Conditions

NeoplasmsPain

Outcome Measures

Primary Outcomes (1)

  • Pain intensity difference (PID) at t=15 minutes

    t=15 minutes

Secondary Outcomes (6)

  • PID 5'

    5 min

  • PID 30'

    30 min

  • PID 45'

    45 min

  • PID 60'

    60 minutes

  • time to onset of meaningful pain relief

    time to onset

  • +1 more secondary outcomes

Interventions

Subcutaneous hydromorphone delivered by pain penDRUG

Subcutaneous hydromorphone delivered by pain pen during breakthrough pain episodes, at max 4 daily. Dose established by opioid conversion from baseline opioids.

Eligibility Criteria

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

You may qualify if:

  • Stable cancer pain requiring the equivalent of 60-1000 mg oral morphine/day
  • breakthrough pain episodes/day
  • Patients must be able, in the opinion of the investigator, to fully comply with trial requirements
  • Patients who have given written informed consent

You may not qualify if:

  • Uncontrolled pain
  • Women who are pregnant, lactating or intend to become pregnant
  • Cardiopulmonary disease that would increase the risk of opioids
  • Neurologic or psychiatric disease that would compromise data collection
  • Recently started chemotherapy or radiotherapy in as far as it would be effective in lowering breakthrough pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. Neurology, Erasmus MC

Rotterdam, 3015 GD, Netherlands

Location

Related Publications (1)

  • Enting RH, Mucchiano C, Oldenmenger WH, Fritzon M, Wallen A, Goslinga-van der Gaag S, Sillevis Smitt PA, Delhaas E. The "pain pen" for breakthrough cancer pain: a promising treatment. J Pain Symptom Manage. 2005 Feb;29(2):213-7. doi: 10.1016/j.jpainsymman.2004.05.010.

    PMID: 15733812BACKGROUND

Related Links

MeSH Terms

Conditions

NeoplasmsPain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Joost L. Jongen, MD

    Dept. Neurology, Erasmus MC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 1, 2005

First Posted

August 2, 2005

Study Start

August 1, 2005

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

October 15, 2008

Record last verified: 2008-10

Locations

NL(1)