Sativex® for Relieving Persistent Pain in Patients With Advanced Cancer

NCT01361607 | Completed Phase 3 Results DMC

• 2 other identifiers: GWCA09622009-016065-29
• Study Type: interventional
• Target: 399
• Locations: 10 countries
• Sites: 68

Brief Summary

This 9-week study aimed to determine the efficacy, safety, and tolerability of nabiximols (Sativex®) as an adjunctive treatment, compared with placebo in relieving uncontrolled persistent chronic pain in participants with advanced cancer. Eligible participants were not required to stop any of their current treatments or medications.

Conditions

Pain; Advanced Cancer

Keywords

Cancer pain; Opioid therapy; Inadequate analgesia; Optimized chronic opioid therapy

Outcome Measures

Primary Outcomes (1)

• Percent Improvement From Baseline In Mean NRS Average Pain At End Of Treatment

  Participants indicated level of pain in the last 24 hours on an 11-point Numerical Rating Scale (NRS), where a score of 0 was "no pain" and 10 was "pain as bad as you can imagine". Baseline = mean score from first day of 3-day eligibility period through to the day before first dose of study drug. End of Treatment = mean score over last (up to) 7 days to the final pain score at End of Treatment or up until Day 35, whichever is earlier, or final score available (prematurely terminated). Percentage improvement from baseline (Imp%) was calculated as: Imp% = (Baseline pain NRS mean - End of Treatment pain NRS mean)/Baseline pain NRS mean \* 100. For participants who died or withdrew due to disease progression, Imp% values were used. For participants who died or withdrew, unrelated to disease progression, before end of Week 5 (no diary data from Day 33 onwards), Imp% was zero for participants whose Imp% value was positive and it was Imp% for participants whose Imp% value was not positive.

  Baseline, End of Treatment (Day 36)

Secondary Outcomes (10)

• Change From Baseline In Mean NRS Average Pain At End Of Treatment

  Baseline, End of Treatment (Day 36)

• Change From Baseline In Mean NRS Worst Pain At End Of Treatment

  Baseline, End of Treatment (Day 36)

• Change From Baseline In Mean Sleep Disruption NRS At End Of Treatment

  Baseline, End of Treatment (Day 36)

• Subject Global Impression Of Change At Last Visit (Up To Day 36)

  Last visit (up to Day 36)

• Physician Global Impression Of Change At Last Visit (Up To Day 36)

  Last Visit (up to Day 36)

Study Arms (2)

Nabiximols

EXPERIMENTAL

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 5 weeks. Nabiximols oromucosal spray contained delta-9-tetrahydrocannabinol (THC) (27 milligram \[mg\]/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

Placebo (GA-0034)

PLACEBO COMPARATOR

Placebo was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day for 5 weeks. Placebo oromucosal spray contained ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring and colorings.

Drug: Placebo (GA-0034)

Interventions

Nabiximols DRUG

Also known as: Sativex®

Nabiximols

Placebo (GA-0034) DRUG

Placebo (GA-0034)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The participant had advanced cancer for which there was no known curative therapy
• The participant had a clinical diagnosis of cancer related pain, which was not wholly alleviated with their current optimized opioid treatment
• The participant received an optimized maintenance dose of Step 3 opioid therapy, preferably with a sustained release preparation, but also allowing a regular maintenance dose of around-the-clock use of immediate release preparations
• The participant received a daily maintenance dose Step 3 opioid therapy of less than or equal to a total daily opioid dose of 500 mg/day of morphine equivalence (including maintenance and break-through opioids)
• The participant was using no more than one type of break-through opioid analgesia

You may not qualify if:

• The participant had any planned clinical interventions that would have affected their pain (for example, chemotherapy or radiation therapy where, in the clinical judgment of the investigator, these would be expected to affect pain)
• The participant was using or had used cannabis or cannabinoid-based medications within 30 days of study entry and is unwilling to abstain for the duration of the study
• The participant 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
• The participant had significantly impaired renal function
• The participant had significantly impaired hepatic function
• 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 was not to be used in conjunction with a female condom as this may not have proven effective)

Sponsors & Collaborators

• Jazz Pharmaceuticals: lead
• Otsuka Pharmaceutical Development & Commercialization, Inc.: collaborator

Study Sites (68)

Unknown Facility

Glendale, California, 91204, United States

Location

Unknown Facility

Santa Rosa, California, 95403, United States

Location

Unknown Facility

Clearwater, Florida, 33756, United States

Location

Unknown Facility

Holiday, Florida, 34691, United States

Location

Unknown Facility

Miami, Florida, 33136, United States

Location

Unknown Facility

Stuart, Florida, 34994, United States

Location

Unknown Facility

Marietta, Georgia, 30060, United States

Location

Unknown Facility

Newnan, Georgia, 30265, United States

Location

Unknown Facility

Stockbridge, Georgia, 30281, United States

Location

Unknown Facility

Gurnee, Illinois, 60031, United States

Location

Unknown Facility

Mount Vernon, Illinois, 62864, United States

Location

Unknown Facility

Ashland, Kentucky, 41101, United States

Location

Unknown Facility

Bossier City, Louisiana, 71111, United States

Location

Unknown Facility

Shreveport, Louisiana, 71105, United States

Location

Unknown Facility

Missoula, Montana, 59802, United States

Location

Unknown Facility

Berlin, New Jersey, 08009, United States

Location

Unknown Facility

New York, New York, 10003, United States

Location

Unknown Facility

New York, New York, 10010-4086, United States

Location

Unknown Facility

Cleveland, Ohio, 44119, United States

Location

Unknown Facility

Lacey, Washington, 98503-1010, United States

Location

Unknown Facility

Vratsa, 3000, Bulgaria

Location

Unknown Facility

Benešov, 256 01, Czechia

Location

Unknown Facility

České Budějovice, 370 01, Czechia

Location

Unknown Facility

České Budějovice, 370 87, Czechia

Location

Unknown Facility

Jablonec nad Nisou, 466 01, Czechia

Location

Unknown Facility

Pilsen, 304 60, Czechia

Location

Unknown Facility

Sokolov, 356 01, Czechia

Location

Unknown Facility

Teplice, 415 01, Czechia

Location

Unknown Facility

Berlin, 10435, Germany

Location

Unknown Facility

Frankfurt, 60311, Germany

Location

Unknown Facility

Fulda, 36039, Germany

Location

Unknown Facility

Hanover, 30625, Germany

Location

Unknown Facility

Jena, 07747, Germany

Location

Unknown Facility

Wiesbaden, 65189, Germany

Location

Unknown Facility

Komárom, 2900, Hungary

Location

Unknown Facility

Nyíregyháza, 4412, Hungary

Location

Unknown Facility

Mexico City, Mexico City, 10700, Mexico

Location

Unknown Facility

Chihuahua City, 31238, Mexico

Location

Unknown Facility

Monterrey, 64710, Mexico

Location

Unknown Facility

Bydgoszcz, 85-796, Poland

Location

Unknown Facility

Częstochowa, 42-200, Poland

Location

Unknown Facility

Częstochowa, 42-217, Poland

Location

Unknown Facility

Działdowo, 13-200, Poland

Location

Unknown Facility

Gdansk, 80-208, Poland

Location

Unknown Facility

Kłodzko, 57-300, Poland

Location

Unknown Facility

Ostrowiec Świętokrzyski, 27-400, Poland

Location

Unknown Facility

Poznan, 61-245, Poland

Location

Unknown Facility

Warsaw, 02-781, Poland

Location

Unknown Facility

Ponce, 00717, Puerto Rico

Location

Unknown Facility

Târgovişte, Dâmbovița County, 130095, Romania

Location

Unknown Facility

Baia Mare, 430031, Romania

Location

Unknown Facility

Brasov, 500366, Romania

Location

Unknown Facility

Brăila, 810325, Romania

Location

Unknown Facility

Bucharest, 011461, Romania

Location

Unknown Facility

Cluj-Napoca, 400015, Romania

Location

Unknown Facility

Constanța, 900591, Romania

Location

Unknown Facility

Focşani, 620165, Romania

Location

Unknown Facility

Iași, 700503, Romania

Location

Unknown Facility

Sibiu, 550245, Romania

Location

Unknown Facility

Suceava, 720237, Romania

Location

Unknown Facility

Cheltenham, Gloucestershire, GL53 0QJ, United Kingdom

Location

Unknown Facility

Withington, Manchester, M20 4BX, United Kingdom

Location

Unknown Facility

Great Yarmouth, Norfolk, NR31 6LA, United Kingdom

Location

Unknown Facility

Coventry, CV2 2HJ, United Kingdom

Location

Unknown Facility

Glasgow, G12 0YN, United Kingdom

Location

Unknown Facility

Manchester, M8 5RB, United Kingdom

Location

Unknown Facility

Norwich, NR4 7UY, United Kingdom

Location

Unknown Facility

Plymouth, PL6 8DH, United Kingdom

Location

Related Publications (1)

• Fallon MT, Albert Lux E, McQuade R, Rossetti S, Sanchez R, Sun W, Wright S, Lichtman AH, Kornyeyeva E. Sativex oromucosal spray as adjunctive therapy in advanced cancer patients with chronic pain unalleviated by optimized opioid therapy: two double-blind, randomized, placebo-controlled phase 3 studies. Br J Pain. 2017 Aug;11(3):119-133. doi: 10.1177/2049463717710042. Epub 2017 May 17.

  PMID: 28785408 BACKGROUND

MeSH Terms

Conditions

Pain; Cancer Pain

Interventions

nabiximols

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Medical Enquiries
• Organization: GW Pharmaceuticals Ltd.

medinfo.USA@gwpharm.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2011
• First Posted: May 27, 2011
• Study Start: May 27, 2011
• Primary Completion: November 24, 2014
• Study Completion: November 24, 2014
• Last Updated: April 12, 2023
• Results First Posted: April 23, 2018

Record last verified: 2023-04

Locations

CZ (7); DE (6); HU (2); US (20); PL (9); PR (1); GB (8); BU (1); ME (3); RO (11)