NCT00484484

Brief Summary

Long-term opioid therapy is commonly administered for the management of severe cancer pain. Increasing doses of opioids are titrated against effects until analgesia is achieved or intolerable adverse effects occur. Ketamine, an N-methyl-D-aspartate (NMDA) receptor antagonist, has been reported to improve analgesia in patients with uncontrolled pain receiving high doses of opioids. This study aims at determining the effectiveness of ketamine as an adjuvant to opioids in relieving cancer pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P25-P50 for phase_3 pain

Timeline
Completed

Started May 2007

Typical duration for phase_3 pain

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

Study Start

First participant enrolled

May 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 8, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 11, 2007

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

May 4, 2011

Status Verified

June 1, 2007

Enrollment Period

2.3 years

First QC Date

June 8, 2007

Last Update Submit

May 3, 2011

Conditions

Pain

Keywords

CancerRefractory painUncontrolled painKetamineUncontrolled cancer pain

Outcome Measures

Primary Outcomes (1)

  • Daily pain score on an 11-point numerical pain rating scale

    after 4 days

Secondary Outcomes (1)

  • Patient Global Impression of Change Clinical Global Impression of Change Daily sleep interference score Patient satisfaction of pain relief Opioids consumption Adverse effects of ketamine-opioids association

    during the 4 days

Study Arms (2)

1

EXPERIMENTAL

Ketamine

Drug: Ketamine

2

EXPERIMENTAL

Ketamine

Drug: Ketamine

Interventions

KetamineDRUG

Ketamine

12

Eligibility Criteria

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

You may qualify if:

  • Hospitalised cancer patients (informed and conscious of the cancer diagnostic)
  • Undergoing opioid treatment for one month at least
  • Refractory pain (score higher than 5 on an 11-point numerical pain rating scale)
  • Ability to score pain on a numerical pain rating scale
  • Patient written agreement

You may not qualify if:

  • Ketamine contraindications
  • Methadone or other NMDA-antagonist treatment
  • Karnofsky index under 10
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Saint Antoine

Paris, 75012, France

Location

MeSH Terms

Conditions

PainNeoplasmsPain, Intractable

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Sylvie ROSTAING-RIGATTIERI, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 8, 2007

First Posted

June 11, 2007

Study Start

May 1, 2007

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

May 4, 2011

Record last verified: 2007-06

Locations

FR(1)