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Intrathecal Bolus Doses of Ziconotide (ZicBol)

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ClinicalTrials.gov Identifier: NCT01373983
Recruitment Status : Completed
First Posted : June 15, 2011
Last Update Posted : December 30, 2014
Sponsor:
Information provided by (Responsible Party):
Emmanuel Backryd, University Hospital, Linkoeping

Tracking Information
First Submitted Date  ICMJE May 25, 2011
First Posted Date  ICMJE June 15, 2011
Last Update Posted Date December 30, 2014
Study Start Date  ICMJE August 2011
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2011)
Visual Analogue Scale Pain Intensity, VASPI, 0-100 mm [ Time Frame: VASPI before injection and then each hour after injection, for 6 hours. ]
The average VASPI-score post-injection will be compared to the pre-injection value to yield a percentage pain reduction. Positive outcome is defined as a reduction of ≥30% in VASPI on two consecutive occasions at the same dosage without significant adverse events. All other cases will be considered as negative outcome.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01373983 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intrathecal Bolus Doses of Ziconotide
Official Title  ICMJE Evaluation of a Structured Algorithm for Intrathecal Bolus Doses of Ziconotide (Prialt®)- The Swedish Ziconotide Bolus Study
Brief Summary The purpose of this study is to evaluate if the effect of ziconotide can be tested by intrathecal bolus doses.
Detailed Description

The intrathecal route for administration of analgesia has been in use in clinical practice for the last 3 decades. It is recommended to trial the patient with intrathecal drug therapy prior to implanting an intrathecal drug delivery device. Trials can be performed using a single bolus injection or by a continuous intrathecal infusion administered through an external catheter. Ziconotide has been approved by EMA for the treatment of chronic severe pain in 2005. So far trials of ziconotide have largely been conducted using external catheters with the drug administered by intrathecal infusion over a number of weeks. Infusions trials have been shown to be expensive, associated with a risk of meningitis and inconvenient to both patient and physician. The option of conducting a trial of intrathecal ziconotide therapy by bolus injection remains unexplored.

This study aims to evaluate the efficacy and safety of a bolus dose of ziconotide (Prialt®) to evaluate the option of continuous administration of the drug via implanted pump in the event of a successful trial.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Peripheral Neuropathy
Intervention  ICMJE Drug: Ziconotide
1.25 or 2.5 mcg or 3.75 mcg i.t. according to an algorithm
Other Name: Prialt
Study Arms  ICMJE ziconotide
Intervention: Drug: Ziconotide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 28, 2014)
26
Original Estimated Enrollment  ICMJE
 (submitted: June 14, 2011)
60
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient, at least 18 years of age
  • suffering from severe chronic (≥ 6 months) pain, who has failed on conventional pharmacological treatment
  • only patients with peripheral neuropathic pain or central neuropathic pain, due to trauma or surgery, will be included
  • Average usual VASPI last week ≥ 40 mm
  • Patient capable of judgment, i.e. able to understand information regarding the drug, the mode of administration and evaluation of efficacy and side effects Signed informed consent

Exclusion Criteria:

  • Limited life expectancy (investigator's judgement)
  • Intrathecal chemotherapy
  • Known or suspected intracranial hypertension
  • Known liver or kidney disease, defined as ASAT, ALAT, Total Bilirubin, ALP or S- Creatinine > 1.2 x ULN
  • Advanced cardio-pulmonary disease (investigator's judgment)
  • Ongoing infection, whether systemically or locally in the lumbar area
  • Coagulopathy (including medication with warfarin, clopidogrel and heparin)
  • Allergy to ziconotide or any of the excipients in the ziconotide vial
  • History of psychiatric disorders which in the investigator's opinion would put the patient at risk
  • Pregnant or lactating woman.
  • Menstruating women must use an effective contraceptive method (contraceptive pill or intrauterine spiral) during the trial period
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01373983
Other Study ID Numbers  ICMJE EudraCT 2010-018920-21
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Emmanuel Backryd, University Hospital, Linkoeping
Study Sponsor  ICMJE University Hospital, Linkoeping
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Emmanuel Bäckryd, MD Pain and Rehabilitation Centre, University Hospital, Linköping, Sweden
PRS Account University Hospital, Linkoeping
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP