Phase III Study of the Safety and Efficacy of Cl-108 in the Treatment of Moderate to Severe Pain

A Double-Blind, Randomized, Placebo-Controlled, Multiple-dose Multi-Center Phase III Study of the Safety and Efficacy of Cl-108 in the Treatment of Moderate to Severe Pain

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01780428

Enrollment

460

Registered

2013-01-31

Start date

2013-01-31

Completion date

2014-12-31

Last updated

2016-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nausea, Pain, Vomiting

Keywords

Pain, Nausea, Vomiting

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.

Interventions

DRUGCL-108 (hydrodocone 7.5 mg, acetaminophen 325 mg, promethazine 12.5 mg)

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame	Description
To compare the occurrence and severity of opioid-induced nausea and vomiting (OINV) associated with CL-108 to Norco.	Over the first 24 hours	After data has been locked.
To demonstrate the efficacy of CL-108 when compared to placebo for the relief of pain following surgical removal of impacted third molar teeth.	over 24 hours (SPID24)	After data has been locked.

Secondary

Measure	Time frame	Description
Reduction of the severity of nausea in patients treated with an opioid-containing pain reliever.	over 6 hours	After data lock.
Reduction of vomiting in patients treated with an opioid-containing pain reliever.	over 6 hours	After data lock.

Other

Measure	Time frame	Description
Elimination of vomiting in patients treated with an opioid-containing pain reliever.	6 hours and 24 hours	After data lock.
Elimination of nausea in patients treated with an opioid-containing pain reliever.	6 hours and 24 hours	After data lock.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026