PainPhase 2NCT00349401
Intrathecal Ketorolac in Patients With Intrathecal Morphine Dose Escalation
A Phase 2 study testing ketorolac and morphine in people with Pain, run by Wake Forest University Health Sciences.
Trial summary
The purpose of this study is to determine how the drug ketorolac, when given with the spinal morphine, affects pain. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pain
- What is being tested?
- ketorolac and morphine
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2006to not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Implanted spinal pump for at last 9 months
- Must be receiving and the dose must have been doubled in the past 6 months
- Currently taking 60-200 mg morphine equivalent as oral rescue per day
- Men and women, ages 18-70
- Weigh no more that 250 pounds
- Neuropathic pain
Who cannot join
- Pregnancy
- Unstable medical problems (heart lung, liver, kidney, or nervous system)
- Allergy to morphine, ketorolac, or drugs which may be used to treat side effects
About this study
The purpose of this study is to determine how the drug ketorolac, when given with the spinal morphine, affects pain.
Read the detailed description
This study is part of a pain center grant that focuses on how pain, especially chronic neuropathic pain, alters the response to traditional and non-traditional analgesics (pain medications).
To treat persons with chronic pain, doctors sometimes implant a permanent tube in the spinal space in the back to give pain medicines. This tube, also called a spinal pump, is used to administer pain medicine directly to the spinal space. The most commonly used medicine given through the spinal pump is morphine which works well for most people, but sometimes loses tolerance, and larger and larger doses are needed, causing many side effects.
The purpose of this study is to find out if another medicine, ketorolac, when given with morphine in the spinal space, can stop or reverse the need for larger and larger doses of morphine. In animals, ketorolac has been shown to slow the need for an increase in morphine dosage and to reduce the morphine dose, while giving good pain control.
This study will enroll 30 individuals with chronic pain below the chest, caused by nerve injury, who are receiving morphine through a spinal pump. After learning to estimate pain accurately using thermal heat testing, participants will be randomly assigned to one of two study groups. Group one will receive the active study medication, ketorolac, while group two receives an inactive control (placebo). All participants will receive morphine (administered through the spinal pump). Afterwards, participants will rate their levels of pain, and provide samples of their spinal fluid (taken from the spinal tube/pump) for study. The above procedure will be repeated over a 4-week period.
Duration of the study for participants is 4 weeks, and includes ten visits to the research center, each lasting less than one hour.
- Conditions
- Pain
- Keywords
- pain, chronic pain, morphine, ketorolac
- Medical subject headings
- Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS pain.
Primary analysis will be the comparison between ketorolac and placebo groups.
Secondary outcomes (1)
Change in oral opioid dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2006 (estimated)
- Study startDec 2006
Why it stopped: Study was not initiated. No subjects were screened or enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James C. Eisenach, M.D., Principal investigator, Wake Forest University Health SciencesRichard Rauck, M.D., Principal investigator, The Center for Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00349401
- Sponsor's protocol ID
- P01NS041386_TRIAL3
- Other IDs
- P01NS041386
- Status last verified
- May 2009
- First submitted
- 5 Jul 2006
- Last updated
- 6 Nov 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrathecal Ketorolac in Patients With Intrathecal Morphine Dose Escalation
- ClinicalTrials.gov ID
- NCT00349401
- Acronym / sponsor ID
- P01NS041386_TRIAL3
- Conditions
- Pain
- Keywords
- pain, chronic pain, morphine, ketorolac
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was not initiated. No subjects were screened or enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Dec 2006
- First posted
- 7 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine how the drug ketorolac, when given with the spinal morphine, affects pain.
Detailed description
This study is part of a pain center grant that focuses on how pain, especially chronic neuropathic pain, alters the response to traditional and non-traditional analgesics (pain medications).
To treat persons with chronic pain, doctors sometimes implant a permanent tube in the spinal space in the back to give pain medicines. This tube, also called a spinal pump, is used to administer pain medicine directly to the spinal space. The most commonly used medicine given through the spinal pump is morphine which works well for most people, but sometimes loses tolerance, and larger and larger doses are needed, causing many side effects.
The purpose of this study is to find out if another medicine, ketorolac, when given with morphine in the spinal space, can stop or reverse the need for larger and larger doses of morphine. In animals, ketorolac has been shown to slow the need for an increase in morphine dosage and to reduce the morphine dose, while giving good pain control.
This study will enroll 30 individuals with chronic pain below the chest, caused by nerve injury, who are receiving morphine through a spinal pump. After learning to estimate pain accurately using thermal heat testing, participants will be randomly assigned to one of two study groups. Group one will receive the active study medication, ketorolac, while group two receives an inactive control (placebo). All participants will receive morphine (administered through the spinal pump). Afterwards, participants will rate their levels of pain, and provide samples of their spinal fluid (taken from the spinal tube/pump) for study. The above procedure will be repeated over a 4-week period.
Duration of the study for participants is 4 weeks, and includes ten visits to the research center, each lasting less than one hour.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Implanted spinal pump for at last 9 months
- Must be receiving and the dose must have been doubled in the past 6 months
- Currently taking 60-200 mg morphine equivalent as oral rescue per day
- Men and women, ages 18-70
- Weigh no more that 250 pounds
Key exclusion criteria (3 listed)
- Pregnancy
- Unstable medical problems (heart lung, liver, kidney, or nervous system)
- Allergy to morphine, ketorolac, or drugs which may be used to treat side effects
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ketorolac | Drug | – |
| morphine | Drug | – |
Primary outcome
VAS pain.
Primary analysis will be the comparison between ketorolac and placebo groups.
1 secondary outcome
Change in oral opioid dose.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James C. Eisenach, M.D. principal investigator
Wake Forest University Health Sciences
Richard Rauck, M.D. principal investigator
The Center for Clinical Research
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ketorolac and morphine in people with Pain, run by Wake Forest University Health Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS pain.. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2017.