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Pain, IntractablePhase 3KETA-1NCT01951911

Effectiveness of Ketamine in Malignant Neuropathic Pain Relief

A Phase 3 study testing Ketamine in people with Pain, Intractable, run by Haukeland University Hospital at 1 site in Norway.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

To see whether the addition of low-dose ketamine to a subcutaneous morphine infusion improves analgesia in patients with neuropathic cancer pain. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Pain, Intractable
What is being tested?
Ketamine
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
1 siteNorway
Study dates
Sep 2013to Oct 2016
Phase
Phase 3
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

  • Age 18-70 years. In-patient. Cancer pain judged to have a neuropathic component. Clinically normal renal and hepatic function. Able to cooperate and understand information. Worst pain at rest or on movement 5 or more (NRS 0-10). Pain currently treated with continuous subcutaneous morphine infusion. The daily morphine dose is 48mg or more per 24 hours and a 30% increase in the daily dose has not provided sufficient pain relief.
  • Not treated with ketamine during the last 48 hours prior to inclusion.
  • -

Who cannot join

  • Reduced renal or hepatic function. Suspicion of morphine toxicity (sedation, hallucination, myoclonus, increasing pain).
  • Increased intracranial pressure (suspicion of cerebral metastases) or cerebral metastases.
  • Unable to cooperate/ understand information. Worst pain at rest or on movement less than 5 on NRS. Current treatment with other opioids than morphine. The patient is undergoing radiotherapy in the pain area, or has received radiotherapy in the pain area within the last four weeks.
  • Changes in the use of analgesics (paracetamol, NSAIDS), adjuvant drugs (antidepressants, antiepileptic, corticosteroids, muscle relaxants) or their dosages less than 2 days prior to inclusion or during the study period.
  • Pregnant and lactating women. Any situation in which an increase in blood pressure would constitute a hazard. Acute intermittent porphyria. Psychiatric illness, epilepsy, alcoholism, glaucoma. Hypersensitivity to any of the drugs ingredients. Current treatment with ketamine.
  • -

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • Haukeland University Hospital

    Bergen, Hordaland, 5021

Other trials in Norway

About this study

Official title: Low-dose Ketamine as Adjuvant Treatment to Morphine in Neuropathic Cancer Pain

To see whether the addition of low-dose ketamine to a subcutaneous morphine infusion improves analgesia in patients with neuropathic cancer pain.

Read the detailed description

Patients with cancer pain judged to have a neuropathic component and receiving pain treatment with a subcutaneous infusion of morphine will be included in a randomized, double blind, placebo-controlled, crossover study. All patients will be recruited from hospital wards (Haukeland University Hospital, Bergen). In the case of patient withdrawal or dropout, new patients will be recruited so that the total number of patients completing the study will be 20. Data from patients not completing the study will solely be used to provide information about adverse effects.

The basic treatment with subcutaneous morphine infusion will be supplemented with a separate subcutaneous infusion of ketamine 1 mg/kg/ 24 hours or NaCl 9 mg/ml (placebo).

After 48 hours (phase 1) there will be a "wash-out" period of minimum 10 hours to minimize carryover effects before the treatment is replaced by the alternative treatment for a further 48 hours (phase 2) in a standard crossover design. The treatment duration is based on ketamine's short plasma half-life which is less than 2 hours after initial equilibration.

Pain intensity (using NRS) will be recorded at rest and on movement x 4 daily. Rescue medication in the form of morphine subcutaneous bolus may be given to the patient as required. There will be a" lockout" time of 1 hour which means that the rescue dose of morphine can be repeated every 60 minutes if necessary, providing the patient is awake and has a respiratory rate of 8 or more per minute.Randomization will be performed by Haukeland University Hospital Pharmacy. The study drug/ placebo will also be prepared by the hospital pharmacy according to a standard instruction.

Being tested
Ketamine, Placebo
Keywords
Pain Management, Ketamine, Palliative care
Medical subject headings
Pain, Intractable, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KetamineDrug

    Also called Ketalar

    Patients will receive either ketamine as subcutaneous infusion or placebo as subcutaneous infusion. The results will be compared with each other.

  • PlaceboDrug

    Also called Sodium chloride 0.9%

Study groups in NCT01951911
Study groupRoleWhat they receive
KetamineActive comparatorKetamine 1 mg per kg per 24 hours as subcutaneous infusion via syringe driver for 48 hours.
Receives: Drug: Ketamine
PlaceboPlacebo comparatorSodium chloride 0.9% administered as a subcutaneous infusion via syringe driver for 48 hours.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in pain intensity compared to baseline.

    Significant reduction in cancer pain intensity will be defined as at least 30% reduction in Numeric Rating Scale (NRS) score compared to baseline.

    Measured: 5 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Sep 2013 (estimated)
  2. Study startSep 2013
  3. Primary completionOct 2016
  4. Study completionOct 2016

Why it stopped: Poor patient recruitment. Vast majority of the patients have exclusions criteria

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01951911
Sponsor's protocol ID
2012/539
Acronym
KETA-1
Status last verified
Jul 2017
First submitted
24 Sep 2013
Last updated
11 Jul 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Mao J, Price DD, Mayer DJ. Mechanisms of hyperalgesia and morphine tolerance: a current view of their possible interactions. Pain. 1995 Sep;62(3):259-274. doi: 10.1016/0304-3959(95)00073-2.

    PubMed 8657426

  • Ko SW, Wu LJ, Shum F, Quan J, Zhuo M. Cingulate NMDA NR2B receptors contribute to morphine-induced analgesic tolerance. Mol Brain. 2008 Jun 17;1:2. doi: 10.1186/1756-6606-1-2.

    PubMed 18803856

  • Mayer DJ, Mao J, Price DD. The association of neuropathic pain, morphine tolerance and dependence, and the translocation of protein kinase C. NIDA Res Monogr. 1995;147:269-98.

    PubMed 8742791

  • Qi X, Evans AM, Wang J, Miners JO, Upton RN, Milne RW. Inhibition of morphine metabolism by ketamine. Drug Metab Dispos. 2010 May;38(5):728-31. doi: 10.1124/dmd.109.030957. Epub 2010 Feb 2.

    PubMed 20124399

  • Bell RF, Eccleston C, Kalso E. Ketamine as adjuvant to opioids for cancer pain. A qualitative systematic review. J Pain Symptom Manage. 2003 Sep;26(3):867-75. doi: 10.1016/s0885-3924(03)00311-7.

    PubMed 12967737

  • Bell RF. Low-dose subcutaneous ketamine infusion and morphine tolerance. Pain. 1999 Oct;83(1):101-3. doi: 10.1016/s0304-3959(99)00096-2.

    PubMed 10506678

  • Freynhagen R, Baron R, Gockel U, Tolle TR. painDETECT: a new screening questionnaire to identify neuropathic components in patients with back pain. Curr Med Res Opin. 2006 Oct;22(10):1911-20. doi: 10.1185/030079906X132488.

    PubMed 17022849

  • Hagelberg NM, Peltoniemi MA, Saari TI, Kurkinen KJ, Laine K, Neuvonen PJ, Olkkola KT. Clarithromycin, a potent inhibitor of CYP3A, greatly increases exposure to oral S-ketamine. Eur J Pain. 2010 Jul;14(6):625-9. doi: 10.1016/j.ejpain.2009.10.003. Epub 2009 Nov 7.

    PubMed 19897389

  • Nisbet AT, Mooney-Cotter F. Comparison of selected sedation scales for reporting opioid-induced sedation assessment. Pain Manag Nurs. 2009 Sep;10(3):154-64. doi: 10.1016/j.pmn.2009.03.001.

    PubMed 19706353

  • Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.

    PubMed 2748771

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ketamine in people with Pain, Intractable, run by Haukeland University Hospital at 1 site in Norway.

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 3 inclusion and 6 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 11 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Change in pain intensity compared to baseline. (time frame: 5 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01951911, which also lists 10 linked publications.

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 11 Jul 2017.

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