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PainPhase 3NCT01337089

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

A Phase 3 study testing Nabiximols in people with Pain and Advanced Cancer, run by Jazz Pharmaceuticals at 128 sites in 18 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pain, Advanced Cancer
What is being tested?
Nabiximols
Could I receive a placebo?
No, everyone receives an active treatment
How many people
660 participants
Where
128 sitesin 18 countries
Study dates
19 Jan 2011to 27 Jan 2016
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

128 sites in 18 countries.

128 sites in 18 countries

United States37 sites

  • Study site

    Ashland, Kentucky, 41101

  • Study site

    Berlin, New Jersey, 08009

  • Study site

    Bossier City, Louisiana, 71111

  • Study site

    Clearwater, Florida, 33756

  • Study site

    Cleveland, Ohio, 44119

  • Study site

    Daytona Beach, Florida, 32117

  • Study site

    El Cajon, California, 92020

  • Study site

    Flat Rock, North Carolina, 28731

  • Study site

    Gilroy, California, 95020

  • Study site

    Glendale, California, 91204

  • Study site

    Holiday, Florida, 34691

  • Study site

    Houston, Texas, 77089

  • Study site

    Jacksonville, Florida, 32257

  • Study site

    Kansas City, Missouri, 64132

  • Study site

    Lacey, Washington, 98503

  • Study site

    Laredo, Texas, 78041

  • Study site

    Lynn Haven, Florida, 32444

  • Study site

    Marietta, Georgia, 30060

  • Study site

    Miami, Florida, 33136

  • Study site

    Missoula, Montana, 59802

  • Study site

    New York, New York, 10003

  • Study site

    New York, New York, 10010

  • Study site

    Newnan, Georgia, 30265

  • Study site

    Philadelphia, Pennsylvania, 19146

  • Study site

    Phoenix, Arizona, 85018

  • Study site

    Phoenix, Arizona, 85028

  • Study site

    Saint Louis Park, Minnesota, 55426

  • Study site

    Salt Lake City, Utah, 84112

  • Study site

    Salt Lake City, Utah, 84124

  • Study site

    Santa Rosa, California, 95403

  • Study site

    Shreveport, Louisiana, 71105

  • Study site

    Stockbridge, Georgia, 30281

  • Study site

    Stuart, Florida, 34994

  • Study site

    Tampa, Florida, 33609

  • Study site

    Winston-Salem, North Carolina, 27103

  • Study site

    Winter Park, Florida, 32789

  • Study site

    Woodlawn, Illinois, 62898

Other trials in United States

Poland16 sites

  • Study site

    Bialystok, 15-250

  • Study site

    Bielsko-Biala, 43-300

  • Study site

    Bydgoszcz, 85-796

  • Study site

    Czeladź, 41-250

  • Study site

    Częstochowa, 42-200

  • Study site

    Częstochowa, 42-217

  • Study site

    Działdowo, 13-200

  • Study site

    Gdansk, 80-208

  • Study site

    Gliwice, 44-101

  • Study site

    Kłodzko, 57-300

  • Study site

    Opole, 45-272

  • Study site

    Ostrowiec Świętokrzyski, 27-400

  • Study site

    Poznan, 61-245

  • Study site

    Warsaw, 02-781

  • Study site

    Warsaw, 02-793

  • Study site

    Włocławek, 87-800

Other trials in Poland

Romania15 sites

  • Study site

    Baia Mare, 430031

  • Study site

    Baia Mare, 430241

  • Study site

    Brăila, 810325

  • Study site

    Bucharest, 010976

  • Study site

    Bucharest, 011461

  • Study site

    Cluj-Napoca, 400015

  • Study site

    Constanța, 900591

  • Study site

    Craiova, 200385

  • Study site

    Focşani, 620165

  • Study site

    Iași, 700106

  • Study site

    Oradea, 410469

  • Study site

    Satu Mare, 440055

  • Study site

    Sibiu, 550245

  • Study site

    Suceava, 720237

  • Study site

    Targoviste, 130095

Other trials in Romania

United Kingdom13 sites

  • Study site

    Bury, BL9 7TD

  • Study site

    Bury St Edmunds, IP33 2QZ

  • Study site

    Cheltenham, GL53 0QJ

  • Study site

    Crumpsall, M8 5RB

  • Study site

    Edinburgh, EH4 2XR

  • Study site

    Edinburgh

  • Study site

    Gorleston-on-Sea, NR31 6LA

  • Study site

    Leeds, LS17 6QD

  • Study site

    Manchester, M20 4BX

  • Study site

    Norwich, NR4 7UY

  • Study site

    Plymouth, PL6 8DH

  • Study site

    Weston-super-Mare, BS23 4TQ

  • Study site

    Withington, M20 4BX

Other trials in United Kingdom

Czechia10 sites

  • Study site

    Benešov, 25601

  • Study site

    České Budějovice, 370 01

  • Study site

    České Budějovice, 370 87

  • Study site

    Jablonec nad Nisou, 46601

  • Study site

    Most, 434 64

  • Study site

    Nová Ves pod Pleší, 262 04

  • Study site

    Ostrava, 708 52

  • Study site

    Pilsen, 304 60

  • Study site

    Sokolov, 356 01

  • Study site

    Teplice, 415 01

Other trials in Czechia

Germany7 sites

  • Study site

    Berlin, 10435

  • Study site

    Frankfurt, 60311

  • Study site

    Jena, 07747

  • Study site

    Lünen, 44534

  • Study site

    Stadtroda, 07646

  • Study site

    Wetzlar, 35578

  • Study site

    Wiesbaden, 65189

Other trials in Germany

Hungary6 sites

  • Study site

    Deszk, 6772

  • Study site

    Komárom, 2900

  • Study site

    Miskolc, 3501

  • Study site

    Nyíregyháza, 4412

  • Study site

    Szekszárd, 7100

  • Study site

    Szikszó, 3800

Other trials in Hungary

Israel4 sites

  • Study site

    Beersheba, 84101

  • Study site

    Haifa, 31096

  • Study site

    Ramat Gan, 52621

  • Study site

    Tsrifin, 60930

Other trials in Israel

Bulgaria3 sites

  • Study site

    Gabrovo, 5300

  • Study site

    Varna, 9010

  • Study site

    Vratsa, 3000

Other trials in Bulgaria

Italy3 sites

  • Study site

    Garbagnate Milanese, 20024

  • Study site

    Piacenza, 29100

  • Study site

    Torino, 10126

Other trials in Italy

Lithuania3 sites

  • Study site

    Klaipėda, 92288

  • Study site

    Šiauliai, 76307

  • Study site

    Vilnius, 08660

Other trials in Lithuania

Latvia2 sites

  • Study site

    Rēzekne, 4600

  • Study site

    Riga, 1038

Other trials in Latvia

Mexico2 sites

  • Study site

    Chihuahua City, 31238

  • Study site

    Distrito Federal, 10700

Other trials in Mexico

Puerto Rico2 sites

  • Study site

    Ponce, 00717

  • Study site

    San Juan, 00927

Other trials in Puerto Rico

Taiwan2 sites

  • Study site

    Taichung, 404

  • Study site

    Tainan, 73657

Other trials in Taiwan

Australia1 site

  • Study site

    Parkville, 3050

Other trials in Australia

Belgium1 site

  • Study site

    Brussels, 1000

Other trials in Belgium

Spain1 site

  • Study site

    Granada, 18014

Other trials in Spain

About this study

Official title: 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.

Read the 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.

Being tested
Nabiximols
Keywords
Cancer pain, Opioid therapy, Inadequate analgesia, Optimized chronic opioid therapy
Medical subject headings
Pain, Cancer Pain

What participants receive

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

  • NabiximolsDrug

    Also called Sativex®

Study groups in NCT01337089
Study groupRoleWhat they receive
Non-comparative, open-label NabiximolsExperimentalNabiximols 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.
Receives: Drug: Nabiximols

What is being measured

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

  1. Percent Of Participants With Treatment-emergent Adverse Events

    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.

    Measured: Baseline, Day 183

Secondary outcomes (4)

  1. Change From Baseline In Mean NRS Average Pain During The Last Period

    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.

    Measured: Baseline, Last Period (Days 156-183) or last 27 days of treatment

  2. Change From Baseline In Mean Sleep Disruption NRS During The Last Period

    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.

    Measured: Baseline, Last Period (Days 156-183) or last 27 days of treatment

  3. Patient Satisfaction Questionnaire At 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.

    Measured: Last Visit (up to Day 183)

  4. Change From Baseline In NRS Constipation At 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.

    Measured: Baseline, Last Visit (up to Day 183)

Timeline

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

  1. First posted18 Apr 2011 (estimated)
  2. Study start19 Jan 2011
  3. Primary completion27 Jan 2016
  4. Study completion27 Jan 2016

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
660 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01337089
Sponsor's protocol ID
GWCA0999
Other IDs
2009-016529-32, 2009
Status last verified
Apr 2023
First submitted
12 Apr 2011
Last updated
12 Apr 2023
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nabiximols in people with Pain and Advanced Cancer, run by Jazz Pharmaceuticals at 128 sites in 18 countries.

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 8 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: finished, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 128 sites in United States, Poland, Romania, United Kingdom, Czechia and 13 more countries. 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. 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?

Yes. Results are posted in the registry (first posted 23 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percent Of Participants With Treatment-emergent Adverse Events (time frame: Baseline, Day 183). 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 NCT01337089.

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 12 Apr 2023.

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