The Pain Pen for Breakthrough Cancer Pain - Full Text View

Sponsored by:	Erasmus Medical Center
Information provided by:	Erasmus Medical Center
ClinicalTrials.gov Identifier:	NCT00125801

Purpose

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.

Condition	Intervention	Phase
Neoplasms Pain	Drug: Subcutaneous hydromorphone delivered by pain pen	Phase III

MedlinePlus related topics: Cancer

Drug Information available for: Hydromorphone Hydromorphone hydrochloride BaseLine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Efficacy Study
Official Title:	Breakthrough Cancer Pain: A Randomized Trial Comparing Oral Morphine Immediate Release and Self-Administration of Subcutaneous Hydromorphone Using an Injection Pen

Further study details as provided by Erasmus Medical Center:

Primary Outcome Measures:

Pain intensity difference (PID) at t=15 minutes [ Time Frame: t=15 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

PID 5' [ Time Frame: 5 min ] [ Designated as safety issue: No ]
PID 30' [ Time Frame: 30 min ] [ Designated as safety issue: No ]
PID 45' [ Time Frame: 45 min ] [ Designated as safety issue: No ]
PID 60' [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]
time to onset of meaningful pain relief [ Time Frame: time to onset ] [ Designated as safety issue: No ]
global efficacy rating at 60' [ Time Frame: 60 min ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	August 2005
Study Completion Date:	May 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Intervention Details:

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

Detailed Description:

Breakthrough pain is an exacerbation of severe pain that occurs on a background of otherwise controlled pain. Breakthrough pain is common in patients with advanced cancer. Current medications to treat breakthrough pain include oral immediate release opioid formulations and more recently oral transmucosal fentanyl citrate.

The pain pen study is a randomized controlled double blind cross-over study comparing the efficacy of oral immediate release morphine with that of subcutaneous hydromorphone, injected through a so called pain pen, on breakthrough pain in cancer patients. Preliminary experience with the pain pen suggests that it has a more rapid time of onset of pain relief than oral formulations.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Stable cancer pain requiring the equivalent of 60-1000 mg oral morphine/day
1-4 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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00125801

Locations

Netherlands
Dept. Neurology, Erasmus MC
Rotterdam, Netherlands, 3015 GD

Sponsors and Collaborators

Erasmus Medical Center

Investigators

Principal Investigator:

Joost L. Jongen, MD

Dept. Neurology, Erasmus MC

More Information

Related Info This link exits the ClinicalTrials.gov site

Publications:

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.

Responsible Party:	Erasmus MC ( Dr. Joost L.M. Jongen )
Study ID Numbers:	EMC 02-115
Study First Received:	August 1, 2005
Last Updated:	October 13, 2008
ClinicalTrials.gov Identifier:	NCT00125801
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study placed in the following topic categories:

Hydromorphone
Morphine
Pain

Additional relevant MeSH terms:

Neoplasms
Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics

Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Pharmacologic Actions
Analgesics, Opioid

ClinicalTrials.gov processed this record on January 16, 2009