Long Term Safety of Sativex Oromucosal Spray (Sativex®; Nabiximols) as Adjunctive Therapy in Patients With Uncontrolled Persistent Chronic Cancer Related Pain

April 7, 2023 updated by: Jazz Pharmaceuticals

A Multicenter, Non-comparative, Open-label Extension Study to Assess the Long Term Safety of Sativex® Oromucosal Spray (Sativex®; Nabiximols) as Adjunctive Therapy in Patients With Uncontrolled Persistent Chronic Cancer Related Pain

This was a six-month open-label extension (OLE) study to evaluate the safety of long-term nabiximols (Sativex®) therapy when used as an adjunctive treatment in participants with advanced cancer. The study provided continued availability of nabiximols to participants who completed a preceding Phase 3 study and new (de novo) participants.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This was a 6-month, multicenter, non-comparative, OLE study to evaluate the safety of long-term nabiximols use as an adjunctive measure in participants with advanced cancer. The study provided continued availability of nabiximols to participants who completed a preceding double-blind phase 3 study and de novo participants. Consenting eligible participants entered the extension study (Day 1) on the same day as the "end of treatment" visit of a parent study or within 7 days of the "end of treatment" visit or on the day of the "safety follow-up visit" of the parent study. The "safety follow-up" visit of a parent study was performed on the same day as Day 1, if the participant did not enter the OLE study on the same day as the "end of treatment" visit of a parent study. De novo participants attended a screening visit 3 to 14 days prior to enrollment (Day 1). All participants commenced dosing on Day 1. Further study visits took place after 2 weeks (Day 15), and every 4 weeks thereafter until the end of treatment period on Day 183 or earlier if the participant withdrew from the study.

Treatment was started as a single spray in the evening on the first day (Day 1). Participants then gradually titrated by 1 additional spray per day to an individualized dose, balancing efficacy and tolerability. Participants had to complete titration within 14 days of their first dose of study drug and then continue at the same dose for the remainder of the study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
660

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Parkville, Australia, 3050
  • Belgium
      • Bruxelles, Belgium, 1000
  • Bulgaria
      • Gabrovo, Bulgaria, 5300
      • Varna, Bulgaria, 9010
      • Vratsa, Bulgaria, 3000
  • Czechia
      • Benešov, Czechia, 25601
      • Jablonec Nad Nisou, Czechia, 46601
      • Most, Czechia, 434 64
      • Nová Ves Pod Pleší, Czechia, 262 04
      • Ostrava, Czechia, 708 52
      • Plzen, Czechia, 304 60
      • Sokolov, Czechia, 356 01
      • Teplice, Czechia, 415 01
      • České Budějovice, Czechia, 370 01
      • České Budějovice, Czechia, 370 87
  • Germany
      • Berlin, Germany, 10435
      • Frankfurt, Germany, 60311
      • Jena, Germany, 07747
      • Lunen, Germany, 44534
      • Stadtroda, Germany, 07646
      • Wetzlar, Germany, 35578
      • Wiesbaden, Germany, 65189
  • Hungary
      • Deszk, Hungary, 6772
      • Komarom, Hungary, 2900
      • Miskolc, Hungary, 3501
      • Nyíregyháza, Hungary, 4412
      • Szekszard, Hungary, 7100
      • Szikszo, Hungary, 3800
  • Israel
      • Beer Sheva, Israel, 84101
      • Haifa, Israel, 31096
      • Ramat Gan, Israel, 52621
      • Zerifin, Israel, 60930
  • Italy
      • Garbagnate Milanese, Italy, 20024
      • Piacenza, Italy, 29100
      • Torino, Italy, 10126
  • Latvia
      • Riga, Latvia, 1038
      • Rēzekne, Latvia, 4600
  • Lithuania
      • Klaipeda, Lithuania, 92288
      • Siauliai, Lithuania, 76307
      • Vilnius, Lithuania, 08660
  • Mexico
      • Chihuahua, Mexico, 31238
      • Distrito Federal, Mexico, 10700
  • Poland
      • Białystok, Poland, 15-250
      • Bielsko-Biala, Poland, 43-300
      • Bydgoszcz, Poland, 85-796
      • Czeladz, Poland, 41-250
      • Częstochowa, Poland, 42-200
      • Częstochowa, Poland, 42-217
      • Działdowo, Poland, 13-200
      • Gdansk, Poland, 80-208
      • Gliwice, Poland, 44-101
      • Klodzko, Poland, 57-300
      • Opole, Poland, 45-272
      • Ostrowiec Swietokrzyski, Poland, 27-400
      • Poznan, Poland, 61-245
      • Warszawa, Poland, 02-781
      • Warszawa, Poland, 02-793
      • Wloclawek, Poland, 87-800
  • Puerto Rico
      • Ponce, Puerto Rico, 00717
      • San Juan, Puerto Rico, 00927
  • Romania
      • Baia Mare, Romania, 430031
      • Baia Mare, Romania, 430241
      • Braila, Romania, 810325
      • Bucuresti, Romania, 011461
      • Bucuresti, Romania, 010976
      • Cluj-Napoca, Romania, 400015
      • Constanţa, Romania, 900591
      • Craiova, Romania, 200385
      • Focsani, Romania, 620165
      • Iaşi, Romania, 700106
      • Oradea, Romania, 410469
      • Satu Mare, Romania, 440055
      • Sibiu, Romania, 550245
      • Suceava, Romania, 720237
      • Târgovişte, Romania, 130095
  • Spain
      • Granada, Spain, 18014
  • Taiwan
      • Taichung, Taiwan, 404
      • Tainan City, Taiwan, 73657
  • United Kingdom
      • Bury, United Kingdom, BL9 7TD
      • Bury Saint Edmunds, United Kingdom, IP33 2QZ
      • Cheltenham, United Kingdom, GL53 0QJ
      • Crumpsall, United Kingdom, M8 5RB
      • Edinburgh, United Kingdom
      • Edinburgh, United Kingdom, EH4 2XR
      • Gorleston-on-Sea, United Kingdom, NR31 6LA
      • Leeds, United Kingdom, LS17 6QD
      • Manchester, United Kingdom, M20 4BX
      • Norwich, United Kingdom, NR4 7UY
      • Plymouth, United Kingdom, PL6 8DH
      • Weston-super-Mare, United Kingdom, BS23 4TQ
      • Withington, United Kingdom, M20 4BX
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85028
      • Phoenix, Arizona, United States, 85018
    • California
      • El Cajon, California, United States, 92020
      • Gilroy, California, United States, 95020
      • Glendale, California, United States, 91204
      • Santa Rosa, California, United States, 95403
    • Florida
      • Clearwater, Florida, United States, 33756
      • Daytona Beach, Florida, United States, 32117
      • Holiday, Florida, United States, 34691
      • Jacksonville, Florida, United States, 32257
      • Lynn Haven, Florida, United States, 32444
      • Miami, Florida, United States, 33136
      • Stuart, Florida, United States, 34994
      • Tampa, Florida, United States, 33609
      • Winter Park, Florida, United States, 32789
    • Georgia
      • Marietta, Georgia, United States, 30060
      • Newnan, Georgia, United States, 30265
      • Stockbridge, Georgia, United States, 30281
    • Illinois
      • Woodlawn, Illinois, United States, 62898
    • Kentucky
      • Ashland, Kentucky, United States, 41101
    • Louisiana
      • Bossier City, Louisiana, United States, 71111
      • Shreveport, Louisiana, United States, 71105
    • Minnesota
      • Saint Louis Park, Minnesota, United States, 55426
    • Missouri
      • Kansas City, Missouri, United States, 64132
    • Montana
      • Missoula, Montana, United States, 59802
    • New Jersey
      • Berlin, New Jersey, United States, 08009
    • New York
      • New York, New York, United States, 10003
      • New York, New York, United States, 10010
    • North Carolina
      • Flat Rock, North Carolina, United States, 28731
      • Winston-Salem, North Carolina, United States, 27103
    • Ohio
      • Cleveland, Ohio, United States, 44119
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19146
    • Texas
      • Houston, Texas, United States, 77089
      • Laredo, Texas, United States, 78041
    • Utah
      • Salt Lake City, Utah, United States, 84124
      • Salt Lake City, Utah, United States, 84112
    • Washington
      • Lacey, Washington, United States, 98503

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participant had completed the parent study within the last seven days
  • Willing and able to give written informed consent
  • Willing and able to comply with all study requirements

Exclusion Criteria:

  • The participant was using cannabis or cannabinoid based medications, other than the parent study investigational medicinal product (IMP), and was unwilling to abstain for the duration of the study
  • Any history or immediate family history of schizophrenia, other psychotic illness, severe personality disorder or other significant psychiatric disorder other than depression associated with their underlying condition
  • Any known or suspected history of a substance abuse/dependence disorder (including opiate abuse/dependence prior to the diagnosis of cancer), current heavy alcohol consumption (more than 60 grams [g] of pure alcohol per day for men, and more than 40 g of pure alcohol per day for women), current use of an illicit drug or current non-prescribed use of any prescription drug
  • Had poorly controlled epilepsy or recurrent seizures (for example, one or more seizure during the last year)
  • Had experienced myocardial infarction or clinically significant cardiac dysfunction within the last 12 months or had a cardiac disorder that, in the opinion of the investigator would have put the participant at risk of a clinically significant arrhythmia or myocardial infarction
  • Had significantly impaired renal function
  • Had significantly impaired hepatic function at the "end of treatment" visit of the parent study
  • Female participants of child-bearing potential and male participants whose partner was of child-bearing potential, unless willing to ensure that they or their partner used effective contraception, for example, oral contraception, double barrier, intra-uterine device, during the study and for 3 months thereafter (however, a male condom should not have been used in conjunction with a female condom as this may not have proven effective)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Non-comparative, open-label Nabiximols
Nabiximols was self-administered by participants as a 100 microliter (μL) oromucosal spray, in the morning and evening, up to a maximum of 10 sprays per day for 6 months. Nabiximols oromucosal spray contained delta-9-tetrahydrocannabinol (THC) (27 milligrams [mg]/milliliter [mL]):cannabidiol (CBD) (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD.
Drug: Nabiximols
Other Names:
  • Sativex®

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percent Of Participants With Treatment-emergent Adverse Events
Time Frame: Baseline, Day 183
Treatment-emergent Adverse Events (TEAEs) were coded according to the Medical Dictionary for Regulatory Activities (MedDRA) dictionary version 17.0. A TEAE is defined as an adverse event with an onset after the start of study drug treatment. The percent of participants who experienced one or more TEAEs is reported.
Baseline, Day 183

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline In Mean NRS Average Pain During The Last Period
Time Frame: Baseline, Last Period (Days 156-183) or last 27 days of treatment

Participants indicated the level of pain experienced in the last 24 hours on an 11-point Numerical Rating Scale (NRS), where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine." Change in mean NRS average pain was calculated as: Last Period NRS average pain score - Baseline NRS average pain score.

A negative value indicates an improvement in average pain score from Baseline.
Baseline, Last Period (Days 156-183) or last 27 days of treatment
Change From Baseline In Mean Sleep Disruption NRS During The Last Period
Time Frame: Baseline, Last Period (Days 156-183) or last 27 days of treatment

Participants indicated the level of sleep disruption experienced in the last 24 hours on an 11-point NRS, where a score of 0 indicated "did not disrupt sleep" and a score of 10 indicated "completely disrupted (unable to sleep at all)." Change in mean sleep disruption NRS was calculated as: Last Period sleep disruption NRS score - Baseline sleep disruption NRS score.

A negative value indicates an improvement in sleep disruption score from Baseline.
Baseline, Last Period (Days 156-183) or last 27 days of treatment
Patient Satisfaction Questionnaire At Last Visit (Up To Day 183)
Time Frame: Last Visit (up to Day 183)
The Patient Satisfaction Questionnaire (PSQ) was used to assess level of satisfaction of the participant with the study drug, with the markers "extremely satisfied, very satisfied, slightly satisfied, neutral, slightly dissatisfied, very dissatisfied, extremely dissatisfied". Last visit refers to the last visit that a participant completed the assessment.
Last Visit (up to Day 183)
Change From Baseline In NRS Constipation At Last Visit (Up To Day 183)
Time Frame: Baseline, Last Visit (up to Day 183)

Participants indicated level of constipation on an 11-point NRS, where a score of 0 was "no constipation", and 10 was "constipation as bad as you can imagine." Last visit refers to the last visit that a participant completed the assessment.

Change in NRS constipation score was calculated as: Last Visit NRS constipation score - Baseline NRS constipation score.

A negative value indicates improvement in condition from Baseline.
Baseline, Last Visit (up to Day 183)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jazz Pharmaceuticals

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Otsuka Pharmaceutical Development & Commercialization, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 19, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 27, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 27, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 12, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 18, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 12, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GWCA0999
  • 2009-016529-32 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain

Clinical Trials on Nabiximols

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings