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Completed

NCT Number: NCT01780428

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

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.

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Key information

Conditions

Pain Nausea Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104-6030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Drug

Other names: Norco (hydrocodone 7.5 mg, acetaminophen 325 mg), Placebo

Placebo

Drug

Primary outcomes

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

    Time frame: Over the first 24 hours

    After data has been locked.

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

    Time frame: over 24 hours (SPID24)

    After data has been locked.

Secondary outcomes

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

    Time frame: over 6 hours

    After data lock.

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

    Time frame: over 6 hours

    After data lock.

Other outcomes

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

    Time frame: 6 hours and 24 hours

    After data lock.

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

    Time frame: 6 hours and 24 hours

    After data lock.

Sponsors and collaborators

Lead sponsor

Charleston Laboratories, Inc

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Jan 31, 2013
Registry last updated
Nov 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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