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Intrathecal Morphine Administration Using Implantable Pump With Continuous or Programmable Flow (PITAC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ICO Paul Papin
ClinicalTrials.gov Identifier:
NCT01567345
First received: March 22, 2012
Last updated: March 28, 2012
Last verified: March 2012
History of Changes
  Purpose

The aim of this study is to compare intrathecal morphine administration: using a pump with continuous or programmable flow.


Condition Intervention Phase
Advanced Cancer
Intractable Pain
 Device: Implantable pump with continuous flow
Device: Implantable pump with programmable flow.
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Two Types of Intrathecal Morphine Administration by Pump for Analgesia in Cancer Patients With Failure of Conventional Analgesic Therapy.

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by ICO Paul Papin:

Primary Outcome Measures:
  • Pain improvement between 2 groups. [ Time Frame: At 3 month ] [ Designated as safety issue: No ]
    Pain will be assessed every day by patient using a Visual Analog Scale (VAS. VAS scores will be compared between 2 groups(continuous or programmable flow). We want to demonstrate the superiority of intrathecal analgesia obtained through programmable flow compared to continuous flow.


Secondary Outcome Measures:
  • Pain improvement with intrathecal analgesia compared to previous antalgic therapy. [ Time Frame: at 3 month ] [ Designated as safety issue: No ]
    Using Visual Analog Scale's score, we want to demonstrate the superiority of intrathecal analgesia compared to previous treatment (pain is assessed through VAS within 4 days before inclusion).

  • Adverse Events assessment. [ Time Frame: every month ] [ Designated as safety issue: Yes ]

    We want to demonstrate a reduction of adverse events related to intrathecal analgesia compared to the previous treatment and to compare the two delivery systems.

    Adverse events due to morphine (6 types) will be scored according to 4 levels, then the sum of these scores will constitute an adverse event severity index ranging from 0 to 18. This index will be compared between the 2 arms and will also be compared to baseline values before introduction of intrathecal analgesia.


  • Patient's performance status improvement. [ Time Frame: At 1 month ] [ Designated as safety issue: Yes ]
    We want to demonstrate improvement of the patient's performance status during intrathecal analgesia compared to the previous treatment and to compare the two delivery systems.

  • Incidence and types of complications. [ Time Frame: every month. ] [ Designated as safety issue: Yes ]
    We want to compare the incidence and type of complications (infectious, morphine-related and co-analgesic treatments-related, due to the intrathecal catheter, to the implantable pump) between the two delivery systems.


Enrollment: 54
Study Start Date: January 2009
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Intrathecal pump with continuous flow
After placement of the implantable pump, continuous flow is scheduled by physician and the patient can't modify it.
 Device: Implantable pump with continuous flow
Insertion of an implantable pump filled up with the analgesic solution. Connection of the catheter to the intrathecal space. Continuous morphine's flow is scheduled.
Other Name: Isomed Pump 8472
Experimental: Intrathecal pump with programmable flow.
After placement of the implantable pump, programmable flow is scheduled by physician and patient can do himself morphine bolus injections for a better control of acute episodes of pain.
 Device: Implantable pump with programmable flow.
Insertion of an implantable pump filled up with the analgesic solution. Connection of the catheter to the intrathecal space. Programmable morphine's flow is scheduled.
Other Name: Synchromed II pump 8637

Detailed Description:

Cancer is frequently associated with pain. In spite of recent improvements in cancer related pain treatment, incidence of cancerous chronic pain did not decrease. Indeed, 15 to 20% of patients are still suffering from intractable pain despite an optimal symptom management.

Treatment of cancer pain is generally based on the WHO analgesic ladder according to 3 steps. Patients with advanced cancer are often treated at WHO step 3 analgesics, i.e. morphine and its derivatives, at high dosages. But increasing the dosage of opioids also leads to accentuation of their adverse events and the corresponding risks.

At this stage of the disease, in patients with failure of conventional analgesic therapy, intrathecal injection of analgesics can be decided in order to relieve pain. 2 types of pumps allow intrathecal morphine administration : continuous or programmable flow. In this study, we want to compare the quality of analgesia obtained through these 2 flows.

  Eligibility

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

Inclusion Criteria:

  • Age > or = 18 years old.
  • Patient with advanced cancer.
  • Patient with severe pain, i.e. a mean daily pain score > or = 5 on an numeric rating scale.
  • Failure of optimal conventional analgesic therapy : either due to intolerable adverse events or to lack of efficacy, i.e. after having tried opioid rotation techniques, different way of administration, use of rapid-acting narcotics to control acute episodes of pain, use of intravenous morphine by PCA pump.
  • Possibility of return home
  • Dated and signed informed consent form.

Exclusion Criteria:

  • Patient's refusal to participate in the study.
  • Ongoing pregnancy.
  • Ongoing systemic infection.
  • Injection site infection.
  • Estimated survival less than 90 days.
  • Allergy or intolerance to morphine.
  • Contraindication to implantation of an intrathecal catheter.
  • Patient treated with a powerful CYP1A2 inhibitor, such as fluvoxamine or enoxacin.
  • Intrathecal chemotherapy planned.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01567345

Locations
France
ICO Paul Papin
Angers, France, 49933
Institut Bergonié
Bordeaux, France, 33076
Centre Hospitalier
Laon, France, 02001
Centre Oscar Lambret
Lille, France, 53020
Hôpital Laennec
Nantes, France, 44093
Polyclinique
Poitiers, France, 86000
Sponsors and Collaborators
ICO Paul Papin
Investigators
Principal Investigator: Denis Dupoiron, MD ICO Paul Papin
  More Information

No publications provided

Responsible Party: ICO Paul Papin
ClinicalTrials.gov Identifier: NCT01567345     History of Changes
Other Study ID Numbers: CPP-401, 2008-005087-14
Study First Received: March 22, 2012
Last Updated: March 28, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by ICO Paul Papin:
Pain
cancer
Intrathecal
 analgesia
Morphine
Implantable pump

Additional relevant MeSH terms:
Pain, Intractable
Neoplasms
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Analgesics
Morphine
Sensory System Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid
Central Nervous System Depressants
Narcotics

ClinicalTrials.gov processed this record on June 17, 2013