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Fentanyl Sublingual Spray in Treating Opioid-tolerant Cancer Patients With or Without Oral Mucositis

NCT ID: NCT00956254

Last Updated: 2013-09-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-10-31

Brief Summary

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This was an open-label, single-dose study to assess the safety, tolerability, and absorption/distribution kinetics of a single 100 µg dose of fentanyl sublingual spray in opioid-tolerant cancer subjects, with or without oral mucositis.

Detailed Description

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RATIONALE: One dose of fentanyl sublingual spray may be effective in relieving pain in opioid-tolerant cancer patients.

PURPOSE: This phase III trial is studying the side effects of fentanyl sublingual spray and to see how well it works in treating opioid-tolerant cancer patients with or without oral mucositis.

OBJECTIVES:

Primary

* To compare the absorption/distribution kinetics of a single dose of fentanyl sublingual spray in opioid-tolerant cancer patients with or without oral mucositis.
* To evaluate the safety and tolerability of this regimen.

OUTLINE: This is a multicenter study.

Patients fast for at least 8 hours before and at least 4 hours after and no water is allowed for at least 1 hour before and at least 1 hour after study drug administration. Patients receive a single dose of fentanyl sublingual spray while in an upright position in clinical care recliners or beds, and remain in an upright posture for at least 4 hours after administration. Patients are instructed not to swallow for at least 5 minutes after administration and not to expectorate the drug.

After study drug administration, 10 blood samples are collected over a 12-hour period for pharmacokinetic and other analyses.

Conditions

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Mucositis Pain Unspecified Adult Solid Tumor, Protocol Specific

Keywords

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mucositis unspecified adult solid tumor, protocol specific pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Fentanyl sublingual spray 100 µg

Participants received a single administration of fentanyl sublingual spray 100 µg sublingually.

Group Type EXPERIMENTAL

Fentanyl sublingual spray

Intervention Type DRUG

Fentanyl was supplied in single-dose glass vials assembled into a delivery device to be used as a sublingual spray.

Interventions

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Fentanyl sublingual spray

Fentanyl was supplied in single-dose glass vials assembled into a delivery device to be used as a sublingual spray.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* No concurrent medications (prescription, over-the-counter, vitamin, or herbal substances) except for hormonal contraceptives and/or ≤ 3 doses of acetaminophen at ≤ 1 g each.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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INSYS Therapeutics Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lisa J. Stearns, MD

Role: PRINCIPAL_INVESTIGATOR

Center for Pain and Supportive Care, PLLC

Locations

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InSys Therapeutics, Incorporated

Scottsdale, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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CDR0000647007

Identifier Type: REGISTRY

Identifier Source: secondary_id

INS-09-011

Identifier Type: -

Identifier Source: org_study_id