NCT01780428

Brief Summary

This is a double-blind, randomized, multiple-dose, placebo- and positive-controlled study of CL-108 (hydrocodone 7.5 mg/APAP 325 mg, promethazine 12.5 mg) in patients with moderate to severe pain following surgical removal of impacted third molar teeth. A positive control ( Norco, a commercial formulation of hydrocodone 7.5 mg/APAP 325 mg) was included to determine the anti-emetic effects of CL-108. The efficacy of CL-108 was also evaluated to placebo for the relief of pain.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
460

participants targeted

Target at P75+ for phase_3 pain

Timeline
Completed

Started Jan 2013

Typical duration for phase_3 pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

January 28, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 31, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

November 3, 2016

Status Verified

November 1, 2016

Enrollment Period

9 months

First QC Date

January 28, 2013

Last Update Submit

November 2, 2016

Conditions

PainNauseaVomiting

Keywords

PainNauseaVomiting

Outcome Measures

Primary Outcomes (2)

  • To compare the occurrence and severity of opioid-induced nausea and vomiting (OINV) associated with CL-108 to Norco.

    After data has been locked.

    Over the first 24 hours

  • To demonstrate the efficacy of CL-108 when compared to placebo for the relief of pain following surgical removal of impacted third molar teeth.

    After data has been locked.

    over 24 hours (SPID24)

Secondary Outcomes (2)

  • Reduction of the severity of nausea in patients treated with an opioid-containing pain reliever.

    over 6 hours

  • Reduction of vomiting in patients treated with an opioid-containing pain reliever.

    over 6 hours

Other Outcomes (2)

  • Elimination of vomiting in patients treated with an opioid-containing pain reliever.

    6 hours and 24 hours

  • Elimination of nausea in patients treated with an opioid-containing pain reliever.

    6 hours and 24 hours

Study Arms (3)

CL-108

EXPERIMENTAL

CL-108 (hydrocodone 7.5 mg, acetaminophen 325 mg, Promethazine 12.5 mg)

Drug: CL-108 (hydrodocone 7.5 mg, acetaminophen 325 mg, promethazine 12.5 mg)

Norco

ACTIVE COMPARATOR

Commercial product containing hydrocodone 7.5 mg. acetaminophen 325 mg

Drug: CL-108 (hydrodocone 7.5 mg, acetaminophen 325 mg, promethazine 12.5 mg)

Placebo

PLACEBO COMPARATOR

CL-108 formulation without API

Drug: Placebo

Interventions

CL-108 (hydrodocone 7.5 mg, acetaminophen 325 mg, promethazine 12.5 mg)DRUG
Also known as: Norco (hydrocodone 7.5 mg, acetaminophen 325 mg), Placebo
CL-108Norco
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Determination of being likely or possibly nausea-prone.
  • Male or non-pregnant and non-lactating female.
  • Surgical extraction of at least 2 impacted third molar teeth
  • A female of child-bearing potential is eligible to participate in this study if she has a negative urine pregnancy test and is using an acceptable method of birth control.
  • Surgical extraction of at least 2 impacted third molar teeth.
  • Presence of at least moderate post-operative pain.

You may not qualify if:

  • Medial Condition, presence of a serious medical condition.
  • Active local infection.
  • Drug Allergy history of hypersensitivity to an Opioid, Promethazine, Acetaminophen.
  • Caffeine use since midnight before the operation.
  • Use of an IND Drug within past 30 days.
  • Previous participation in this study.
  • Pregnant or lactating.
  • Employee of the PI,sub-investigator or Charleston Labs or relative of an employee.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104-6030, United States

Location

Related Links

MeSH Terms

Conditions

PainNauseaVomiting

Interventions

AcetaminophenPromethazineoxycodone-acetaminophenHydrocodone

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPropylaminesPhenothiazinesSulfur CompoundsHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsCodeineMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Design

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

Study Record Dates

First Submitted

January 28, 2013

First Posted

January 31, 2013

Study Start

January 1, 2013

Primary Completion

October 1, 2013

Study Completion

December 1, 2014

Last Updated

November 3, 2016

Record last verified: 2016-11

Locations

US(1)