Extension Study to Evaluate the Safety of Q8003 in Patients With Acute Moderate to Severe Pain

NCT ID: NCT00565760

Last Updated: 2012-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2008-03-31

Brief Summary

This is a Phase 3 double-blind, multiple dose safety extension study of Q8003 administered at daily doses up to 36 mg morphine/24 mg oxycodone (Q8003 36mg/24mg) over a treatment period of up to 4 weeks. Patients with acute moderate to severe pain who have completed participation in one of the designated QRxPharma, Inc. acute pain lead-in studies will be eligible for this trial.

Detailed Description

The currently designated acute pain lead-in study is Study Q8003-007, which is a safety and efficacy study of Q8003 in the management of post-bunionectomy pain.

Conditions

Acute Moderate to Severe Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Group Type: EXPERIMENTAL

Q8003

Intervention Type: DRUG

Capsules

2

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Capsules

Interventions

Q8003

Capsules

Intervention Type: DRUG

Placebo

Capsules

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patient has completed participation in one of the designated eligible QRxPharma, Inc. acute pain lead-in studies.
• Patient has a BMI ≤35.
• Patient will anticipate taking the first dose of study medication in this Extension Study no longer than 24 hours after taking the final dose of study medication in the lead-in study.
• Patient is in good health as determined by the Investigator via physical examination at the Extension Study Baseline Visit.
• If female, patient is at least one year post-menopausal (defined as one year without menses), surgically sterile (must be documented), or practicing effective contraception, in the opinion of the Investigator, and be willing to continue to use effective contraception for the duration of participation in the study.
• If female, patient is non-lactating, and if of child-bearing potential, has a negative urine pregnancy test result at Baseline Visit.
• Patient has a pulse-oximetry measurement ≥95%, a respiration rate ≥12 breaths/minute, systolic blood pressure ≥100 mm Hg, and diastolic blood pressure ≥50 mm Hg at the Extension Study Baseline Visit.
• Patient is willing to refrain from driving throughout the duration of participation in the study.

Exclusion Criteria

• Patient has acute asthma, head injury, elevated intracranial pressure, convulsive states, congestive heart failure (NYHA classification of III or IV), current cardiac arrhythmia, current transient cerebral ischemic attacks, current uncontrolled unstable co-existent systemic disease, serious intercurrent illness, other medical condition, laboratory abnormality, or extenuating circumstance that, in the opinion of the Investigator, would preclude participation in the study.
• Patient has allergy, hypersensitivity, or contraindications to opioids.
• Patient has poorly controlled hypertension (systolic blood pressure >180 mm Hg or diastolic blood pressure >95 mm Hg despite antihypertensive medication) at the Extension Study Baseline Visit.
• Patient is currently taking tramadol or anticipates taking tramadol during the course of the study.
• Patient is currently taking antipsychotic drugs, monoamine oxidase inhibitors, muscle relaxants, or medications for the treatment of depression.
• Patient is currently taking any opioid analgesic other than Q8003 or other opioid study medication, or anticipates taking any opioid analgesic other than Q8003 or other opioid study medication during the course of the study.
• Patient is at high risk of addiction: patient has a history of substance abuse (excluding nicotine or caffeine), a family history of substance abuse, or a history of adverse consequences related to substance abuse including legal issues.
• Patient has a history of drug or alcohol use or dependence that, in the opinion of the Investigator, would interfere with adherence to study requirements.
• Patient has any medical, psychological, cognitive, social and/or legal conditions that could, in the opinion of the Investigator, compromise patient safety or interfere with the ability of the patient to give informed consent and/or comply with all study requirements, including the necessary time commitment.
• Patient has received any investigational medication within 30 days prior to the first dose of study drug in this study other than Q8003 or is scheduled to receive any investigational drug other than Q8003 during the course of this study.
• Patient has previously been admitted to the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

QRxPharma Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Warren Stern, Ph.D.

Role: STUDY_DIRECTOR

QRxPharma Inc.

Locations

Advanced Clinical Research Institute

Anaheim, California, United States

Chesapeake Research Group

Pasadena, Maryland, United States

Advanced Regional Center for Foot and Ankle Care

Altoona, Pennsylvania, United States

Scirex Research Center

Houston, Texas, United States

Lifetree Clinical Research

Salt Lake City, Utah, United States

Jean Brown Research

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

Q8003-010

Identifier Type: -

Identifier Source: org_study_id