Clinical Trial Page

Summary
EudraCT Number:2004-003824-36
Sponsor's Protocol Code Number:SATEME-08
National Competent Authority:Spain - AEMPS
Clinical Trial Type:EEA CTA
Trial Status:Ongoing
Date on which this record was first entered in the EudraCT database:2005-09-05
Trial results
Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL
A. Protocol Information
A.1Member State ConcernedSpain - AEMPS
A.2EudraCT number2004-003824-36
A.3Full title of the trial
Randomized, double blind, parallel groups, placebo controlled pivotal clinical trial to asses preliminary efficacy and security of a sublingual Cannabis Standardized Extract (Sativex) added to reference treatment for prevention and treatment of nausea and late vomiting induced by moderately emetogenic chemotherapy.
A.3.2Name or abbreviated title of the trial where available
SATEME-08
A.4.1Sponsor's protocol code numberSATEME-08
A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
A.8EMA Decision number of Paediatric Investigation Plan
B. Sponsor Information
B.Sponsor: 1
B.1.1Name of SponsorFundació Institut Català de Farmacologia
B.1.3.4CountrySpain
B.3.1 and B.3.2Status of the sponsorNon-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1Name of organisation providing support
B.4.2Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1Name of organisation
B.5.2Functional name of contact point
D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3IMP RoleTest
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation Information not present in EudraCT
D.2.1.1.1Trade name Sativex
D.2.1.2Country which granted the Marketing AuthorisationCanada
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product namedelta9 tetrahidrocannabinol (THC) y cannabidiol (CBD)
D.3.2Product code THC CBD
D.3.4Pharmaceutical form Sublingual spray
D.3.4.1Specific paediatric formulation Information not present in EudraCT
D.3.7Routes of administration for this IMPSublingual use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNDelta-9-Tetrahidrocannabinol (THC)
D.3.10 Strength
D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
D.3.10.2Concentration typeequal
D.3.10.3Concentration number2.5/100
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin Information not present in EudraCT
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product Information not present in EudraCT
D.3.11.8Extractive medicinal product Information not present in EudraCT
D.3.11.9Recombinant medicinal product Information not present in EudraCT
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product No
D.IMP: 2
D.1.2 and D.1.3IMP RoleTest
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation Information not present in EudraCT
D.2.1.1.1Trade name Sativex
D.2.1.2Country which granted the Marketing AuthorisationCanada
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product namedelta9 tetrahidrocannabinol (THC) y cannabidiol (CBD)
D.3.2Product code THC CBD
D.3.4Pharmaceutical form Sublingual spray
D.3.4.1Specific paediatric formulation Information not present in EudraCT
D.3.7Routes of administration for this IMPSublingual use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNCannabiniol (CBD)
D.3.10 Strength
D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
D.3.10.2Concentration typeequal
D.3.10.3Concentration number2.5/100
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin Information not present in EudraCT
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product Information not present in EudraCT
D.3.11.8Extractive medicinal product Information not present in EudraCT
D.3.11.9Recombinant medicinal product Information not present in EudraCT
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product No
D.8 Information on Placebo
D.8 Placebo: 1
D.8.1Is a Placebo used in this Trial?Yes
D.8.3Pharmaceutical form of the placeboSublingual spray
D.8.4Route of administration of the placeboSublingual use
E. General Information on the Trial
E.1 Medical condition or disease under investigation
E.1.1Medical condition(s) being investigated
Chemotherapy induced nausea and vomiting
MedDRA Classification
E.1.3Condition being studied is a rare disease No
E.2 Objective of the trial
E.2.1Main objective of the trial
To asses preliminary efficacy of an individualized treatment line of Sativex administered by sublingual route added to standard treatment for prevention and treatment of nausea and late vomiting (during the following 120 hours after chemotherapy administration) in patients not responding to standard antihemetic treatment after first cycle of moderately emetogenic chemotherapy
E.2.2Secondary objectives of the trial
To asses preliminary efficacy of Sativex preventing nausea and vomiting during 1st 24hours following chemotherapy in non responders to Standard treatment.
To asses preliminary efficacy of Sativex preventing late vominitng and nausea and also improvement in length and intensity before and after treatment
To measure Sativex impact on pain, asthenia, sleep quality, emotional condition, subjective effects and daily activities.
Mean daily dose and pharmacokinetics.
Changes in analgesic treatment with opioids.
To asses patient and investigator satisfaction rate
E.2.3Trial contains a sub-study Information not present in EudraCT
E.3Principal inclusion criteria
•18 years or older
•Solid malignancy diagnosed to be treated with 1st line chemotherapy (2nd cycle) mildly emetogenic. (1 day carboplatin/cisplatin/ciclophosfamide, doxorubicine, idarrubicine, irinotecan, mitoxantrona or epirrubicine) combine or in monotherapy.
•Patients with at least 1 vomit/day and nausea scored > 25 mm EAV despite antiemetiec prophylaxis treatment.
•Patients receiving prophylaxis treatment for late vomits and nausea
•Karnofsky scale = or >70
•Haematological and metabolic condition stable enough to receive the chemotherapy.
Leuco > 3000/mm3
Platls >100.000/mm3
Serum Creatinine <1,5 mg/dl
•Able to complete questionnaires, diary and visual scale.
•Patien having given informed consent
E.4Principal exclusion criteria
•more than 1 chemotherapy cycle. Biologic or hormonal therapies are permitted.
•Background of hypersensitivity to cannabinoids.
•cannabinoids use within 30d before inclusion
•Systemic corticosteroid treatment within 72h before 1st dose of study medication (only accepted if pre-treatment to chemotherapy)
•Patients receiving abdominal or pelvic radiotherapy within 7 days before study drug 1ss dose or so scheduled for the following 6 days
•Patients with vomits and nauseas due to known reason including (but no limited): GI obstruction, intracranial pressure, hypocalcaemia, active peptic ulcers.
•Patients with active systemic infection or any other uncontrolled conditions (apart from cancer) that according to investigator judgement could affect patient security or study results
•Patients with AST and or ALT>2,5 x UNL without diagnosed hepatic metastasis (or x5 if hepatic affection diagnosed)
•Patients receiving investigational drug within 30days before inclusion or willing to receive it during the study period.
•Drug / Alcohol abuse background (Confirmed Test Insta-Check)
•History of cardiovascular illness.
•Cognitive deterioration affecting patient collaboration.
•Severe psychiatric illness (schizophrenia, severe depression, etc..).
•Pregnant or breast-feeding woman
•Driving needs or dangerous engine managementneeds.
E.5 End points
E.5.1Primary end point(s)
Primary endpoint is the average of patients in each study arm showing a partial or complete response to treatment.
E.6 and E.7 Scope of the trial
E.6Scope of the trial
E.6.1Diagnosis No
E.6.2Prophylaxis Yes
E.6.3Therapy No
E.6.4Safety Yes
E.6.5Efficacy Yes
E.6.6Pharmacokinetic Yes
E.6.7Pharmacodynamic No
E.6.8Bioequivalence No
E.6.9Dose response No
E.6.10Pharmacogenetic Information not present in EudraCT
E.6.11Pharmacogenomic No
E.6.12Pharmacoeconomic No
E.6.13Others No
E.7Trial type and phase
E.7.1Human pharmacology (Phase I) No
E.7.1.1First administration to humans Information not present in EudraCT
E.7.1.2Bioequivalence study Information not present in EudraCT
E.7.1.3Other Information not present in EudraCT
E.7.1.3.1Other trial type description
E.7.2Therapeutic exploratory (Phase II) No
E.7.3Therapeutic confirmatory (Phase III) Yes
E.7.4Therapeutic use (Phase IV) No
E.8 Design of the trial
E.8.1Controlled Yes
E.8.1.1Randomised Yes
E.8.1.2Open Information not present in EudraCT
E.8.1.3Single blind Information not present in EudraCT
E.8.1.4Double blind Yes
E.8.1.5Parallel group Information not present in EudraCT
E.8.1.6Cross over Information not present in EudraCT
E.8.1.7Other Information not present in EudraCT
E.8.2 Comparator of controlled trial
E.8.2.1Other medicinal product(s) Information not present in EudraCT
E.8.2.2Placebo Yes
E.8.2.3Other Information not present in EudraCT
E.8.3 The trial involves single site in the Member State concerned No
E.8.4 The trial involves multiple sites in the Member State concerned Yes
E.8.5The trial involves multiple Member States No
E.8.6 Trial involving sites outside the EEA
E.8.6.1Trial being conducted both within and outside the EEA No
E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
E.8.7Trial has a data monitoring committee Information not present in EudraCT
E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
E.8.9 Initial estimate of the duration of the trial
E.8.9.1In the Member State concerned years1
E.8.9.1In the Member State concerned months
E.8.9.1In the Member State concerned days
E.8.9.2In all countries concerned by the trial years1
F. Population of Trial Subjects
F.1 Age Range
F.1.1Trial has subjects under 18 No
F.1.1.1In Utero No
F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
F.1.1.3Newborns (0-27 days) Information not present in EudraCT
F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
F.1.1.5Children (2-11years) Information not present in EudraCT
F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
F.1.2Adults (18-64 years) Yes
F.1.3Elderly (>=65 years) No
F.2 Gender
F.2.1Female Yes
F.2.2Male Yes
F.3 Group of trial subjects
F.3.1Healthy volunteers Information not present in EudraCT
F.3.2Patients Yes
F.3.3Specific vulnerable populations Information not present in EudraCT
F.3.3.1Women of childbearing potential not using contraception No
F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
F.3.3.3Pregnant women No
F.3.3.4Nursing women No
F.3.3.5Emergency situation No
F.3.3.6Subjects incapable of giving consent personally No
F.3.3.7Others No
F.4 Planned number of subjects to be included
F.4.1In the member state60
G. Investigator Networks to be involved in the Trial
N. Review by the Competent Authority or Ethics Committee in the country concerned
N.Competent Authority Decision Authorised
N.Date of Competent Authority Decision2005-09-15
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion2004-12-15
P. End of Trial
P.End of Trial StatusOngoing

Sponsors and Collaborators

Medical Conditions

Drug Interventions

3
Subscribe