Fentanyl Administered Intraorally for Rapid Treatment of Orthopedic Pain

NCT00685295 | Completed Phase 1 Results DMC

• 1 other identifier: FAIRTOP
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Assess whether transbuccal fentanyl provides more rapid relief of orthopedic pain, than does the comparator Percocet

Conditions

Pain, Fracture, Sprain

Keywords

Emergency Department; acute

Outcome Measures

Primary Outcomes (2)

• Time to Analgesia

  Time it took for subjects to achieve a pain score reduction of 2 units (on a 0 to 10 scale)

  60 minutes

• Pain Reduction

  Number of subjects who reached pain reduction. A subject was deemed to have reached pain reduction if there was a two-point drop in pain scale (0-10).

  60 minutes

Secondary Outcomes (1)

• Occurrence of Untoward Opioid Side Effects

  120 minutes

Study Arms (2)

Arm 1 / Fentora

EXPERIMENTAL

Intervention Group: Subject receives: 1. placebo oral/swallowed pill 2. Fentanyl (Fentora) 100mcg rapidly dissolving transbuccal tablet

Drug: Fentanyl

Arm 2 / Percocet/Prevacid

ACTIVE COMPARATOR

Active Comparator Group: Subject receives: 1. Oxycodone/APAP (Percocet) 5/325 mg oral/swallowed pill 2. Lansoprazole 15 mg (Prevacid) comparator rapidly dissolving transbuccal tablet

Drug: Lansoprazole; Drug: Oxycodone

Interventions

Fentanyl DRUG

Fentanyl rapid dissolving tablet 100mcg

Also known as: Fentora

Arm 1 / Fentora

Lansoprazole DRUG

lansoprazole 15mg rapidly dissolving tablet

Also known as: Prevacid SoluTab

Arm 2 / Percocet/Prevacid

Oxycodone DRUG

Oxycodone 5/325 mg tablet

Also known as: Percocet

Arm 2 / Percocet/Prevacid

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years of age
• Present to ED with a chief complaint of extremity injury
• Negative pregnancy test (urine or blood)
• Clinician judges subject to need extremity radiography to rule out a fracture
• Subjects must indicate that their pain is of sufficient severity to warrant treatment with a pain medication stronger than acetaminophen or aspirin.
• Subject's treating ED provider is aware of, and approves, participation (i.e. participation cannot be allowed to impair provision of standard patient care).

You may not qualify if:

• Treating provider judges that IV analgesia is required
• Allergy to acetaminophen or to any opiate/opioid
• Currently taking phenothiazines or CNS depressants (including alcohol), or if subject has taken MAO inhibitors or SSRIs within the past two weeks
• Already taken or been administered opioid analgesia for their current injury
• Chronic opioid therapy or if the subject (or their medical records) indicate a history of opioid abuse
• Breastfeeding mothers
• If subject is planning to drive home after their ED visit, or if they are judged for any other reason to be non-candidates for opioid therapy.
• hypersensitivity to lansoprazole
• phenylketonuria

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Pain; Fractures, Bone; Sprains and Strains; Emergencies

Interventions

Fentanyl; Lansoprazole; Oxycodone; oxycodone-acetaminophen

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Stephen Thomas
• Organization: Harvard/MGH

sthomasmd@gmail.com

6177267622

Study Officials

• Stephen H Thomas, MD, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: May 23, 2008
• First Posted: May 28, 2008
• Study Start: August 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: February 9, 2017
• Results First Posted: February 9, 2017

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)