A Study Of The Effectiveness Of Wafermine Alone And In Combination With Opioids In Subjects Undergoing Bunionectomy

NCT02541396 | Completed Phase 2 DMC

• 1 other identifier: KET009
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety and effectiveness of Wafermine administered with and without an opioid medication for acute pain following bunionectomy surgery.

Conditions

Acute Pain

Keywords

Bunion; Bunionectomy

Outcome Measures

Primary Outcomes (1)

• Total Pain Relief (TOTPAR)

  Subjects will use an 11 point numerical pain rating scale (NPRS) where 0=No Pain and 10= Worst Possible pain to rate their pain at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, 11.5, 12, 12.5, 13, 13.5, 14, 14.5, 15, 15.5, 16 and 24 hours. TOTPAR is computed as follows at the specified time points: TOTPAR-t = ∑ \[T(i) - T(i-1) \* \[(PR(i-1) + PR(i))/2\]

  24 hours

Secondary Outcomes (12)

• Percent with maximum Pain Relief

  24 hours

• Proportion of Subjects requiring "Rescue Medication"

  24 hours

• Time to onset of perceptible and meaningful pain relief

  24 hours

• Time to onset of complete pain relief (Peak Relief)

  24 hours

• Time to maximum reduction in pain intensity

  24 hours

Study Arms (7)

Group A

PLACEBO COMPARATOR

Placebo wafers given every 2 hours Placebo capsule given every 4 hours Placebo wafers "top-up" dose given at hour 1

Drug: Placebo

Group B

ACTIVE COMPARATOR

Placebo wafers given every 2 hours Oxycodone given every 4 hours Placebo wafers "top-up" dose given at hour 1

Drug: Oxycodone

Group C

EXPERIMENTAL

Wafermine™ 35 mg wafer + placebo wafer given every 2 hours Placebo capsule given every 4 hours Wafermine™ 35 mg wafer + placebo wafer "top-up" dose at hour 1

Drug: Wafermine

Group D

EXPERIMENTAL

Wafermine™ 35 mg wafer + placebo wafer given every 2 hours Oxycodone 5 mg capsule every 4 hours Wafermine™ 35 mg "wafer + placebo wafer top-up" dose at hour 1

Drug: Wafermine; Drug: Oxycodone

Group E

EXPERIMENTAL

Wafermine™ 35 mg + placebo wafer given every 4 hours Placebo wafers given every 2 hours Placebo capsule given every 4 hours Wafermine™ 35 mg wafer + placebo wafer "top-up" dose at hour 1

Drug: Wafermine

Group F

EXPERIMENTAL

Wafermine™ 35 mg + placebo wafer given every 4 hours Placebo wafers given every 2 hours Oxycodone 5 mg given every 4 hours Wafermine™ 35 mg wafer + placebo wafer "top-up" dose at hour 1

Drug: Wafermine; Drug: Oxycodone

Group G

EXPERIMENTAL

Wafermine™ 70 mg given every 4 hours Placebo wafer given every 2 hours Placebo capsule given every 4 hours 2 Placebo wafers "top-up" dose at hour 1

Drug: Wafermine

Interventions

Wafermine DRUG

35 or 70 mg ketamine in a sublingual wafer

Also known as: Sublingual ketamine

Group C; Group D; Group E; Group F; Group G

Oxycodone DRUG

5 mg oxycodone capsule

Group B; Group D; Group F

Placebo DRUG

Placebo capsule or placebo wafer

Group A

Eligibility Criteria

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

You may qualify if:

• Scheduled for a bunionectomy (with no additional procedures).
• Healthy, ambulatory subjects able to understand and willing to comply with study procedures, study restrictions and requirements.
• Body mass index (BMI) ≥19 to ≤33 kg/m2.
• Females: Not pregnant, not lactating, and not planning to become pregnant during the study.
• Females: Be abstinent, surgically sterile, at least two years post-menopausal; or medically acceptable contraception.
• Able to read and understand English.
• Able to swallow oral capsules whole.

You may not qualify if:

• Allergy, intolerance, or contraindication to ketamine, oxycodone, morphine, ibuprofen or surgical medications.
• Clinically significant medical condition.
• History of illicit drug use or alcohol abuse and not in full remission.
• Positive test for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) at the screening visit.
• Clinically significant 12 lead ECG abnormalities at screening.
• Smokers who are unwilling to abstain during the inpatient stay.

Sponsors & Collaborators

• iX Biopharma Ltd.: lead
• Jean Brown Research: collaborator

Study Sites (1)

Jean Brown Research

Salt Lake City, Utah, 84124, United States

Location

MeSH Terms

Conditions

Acute Pain; Bunion

Interventions

Oxycodone

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2015
• First Posted: September 4, 2015
• Study Start: October 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 23, 2016

Record last verified: 2016-02

Locations

US (1)