A Study of Sativex® for Pain Relief in Patients With Advanced Malignancy. - Study Results

A Study of Sativex® for Pain Relief in Patients With Advanced Malignancy. (SPRAY)

This study has been completed.

Study NCT00530764 Information provided by GW Pharmaceuticals Ltd.

First Received on September 13, 2007. Last Updated on June 16, 2011 History of Changes

Results First Received: March 2, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Supportive Care
Conditions:	Palliative Care Pain Cancer
Interventions:	Drug: Sativex Low Dose Drug: Sativex Medium Dose Drug: Sativex High Dose

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Sativex High Dose Group	Range of 11 to 16 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 43.2mg THC and 40mg CBD.
Sativex Medium Dose Group	Range of 6 to 10 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 27mg THC and 25mg CBD.
Sativex Low Dose Group	Range of 1 to 4 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 10.8mg THC and 10mg CBD.
Placebo	Range of 1-16 sprays per day of placebo spray

Participant Flow: Overall Study

	Sativex High Dose Group	Sativex Medium Dose Group	Sativex Low Dose Group	Placebo
STARTED	90	88	91	91
COMPLETED	59	67	71	66
NOT COMPLETED	31	21	20	25

Baseline Characteristics

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Reporting Groups

	Description
Sativex High Dose Group	Range of 11 to 16 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 43.2mg THC and 40mg CBD.
Sativex Medium Dose Group	Range of 6 to 10 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 27mg THC and 25mg CBD.
Sativex Low Dose Group	Range of 1 to 4 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 10.8mg THC and 10mg CBD.
Placebo	Range of 1-16 sprays per day of placebo spray

Baseline Measures

	Sativex High Dose Group	Sativex Medium Dose Group	Sativex Low Dose Group	Placebo	Total
Number of Participants [units: participants]	90	88	91	91	360
Age [units: years] Mean ± Standard Deviation	58 ± 11.2	59 ± 31.1	59 ± 12.3	56 ± 12.2	58 ± 12.2
Gender [units: participants]
Female	42	39	46	47	174
Male	48	49	45	44	186

Outcome Measures

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1. Primary:

Number of Patients With at Least 30% Improvement in Numerical Rating Scale (NRS) Average Pain Score From Baseline [ Time Frame: 5 Weeks: Baseline (first 3 days) - Week 5 (last 3 days) ]

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2. Secondary:

Change in Cumulative Average Pain Response Curves [ Time Frame: Baseline to end of treatment (Week 5) ]

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3. Secondary:

Change in Mean Daily NRS Pain Score (Average Pain). [ Time Frame: 5 Weeks: Baseline (first 3 days) - End of Treatment (last 3 days of week 5) ]

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4. Secondary:

Change in Mean Daily NRS Pain Score (Worst Pain). [ Time Frame: 5 Weeks: Baseline (first 3 days) - End of Treatment (last 3 days of week 5) ]

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5. Secondary:

Change in Sleep Disruption NRS [ Time Frame: 5 Weeks: Baseline - End of Treatment (Last 3 days of Week 5) ]

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6. Secondary:

Change in Brief Pain Inventory – Short Form (BPI-SF) [ Time Frame: Baseline (Visit 2) and End of Treatment (End of Week 5 or premature termination) ]

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7. Secondary:

Change in Patient Assessment of Constipation Quality of Life (PAC-QoL) [ Time Frame: Baseline (Visit 2) and End of Treatment (Week 5 or premature termination) ]

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8. Secondary:

Change in Patient Global Impression of Change - PGIC [ Time Frame: End of Week 5 ]

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9. Secondary:

Change in Montgomery Asberg Depression Rating Scale (MADRS) [ Time Frame: Baseline and End of Treatment (Week 5 or premature termination) ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Restriction Description:

Publication Policy:

GW will coordinate the dissemination of data from this study and may solicit input and assistance from the principal investigator. All publications for example, manuscripts, abstracts, oral/slide presentations or book chapters based on this study, must be submitted to GW for corporate review before release.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Matthew Hersch, Senior Clinical Project Manager
Organization: GW Pharma Ltd.
phone: +44 1353 616600
e-mail: mhersch@gwpham.com

No publications provided

Responsible Party:	Clinical Project Manager, GW Pharmaceuticals Ltd
ClinicalTrials.gov Identifier:	NCT00530764 History of Changes
Other Study ID Numbers:	GWCA0701
Study First Received:	September 13, 2007
Results First Received:	March 2, 2011
Last Updated:	June 16, 2011
Health Authority:	United States: Food and Drug Administration