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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
QRxPharma Inc.
ClinicalTrials.gov Identifier:
NCT00565760
First received: November 28, 2007
Last updated: May 15, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Acute Moderate to Severe Pain
Drug: Q8003
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Multi-Center Extension Study to Evaluate the Safety and Efficacy of Q8003 in Patients With Acute Moderate to Severe Pain

Further study details as provided by QRxPharma Inc.:

Primary Outcome Measures:
  • Safety: adverse events [ Time Frame: Up to 4 weeks with 3 weeks follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy: difference in pain intensity scores from baseline [ Time Frame: Up to 4 weeks with 3 weeks follow-up ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: November 2007
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Q8003
Capsules
Placebo Comparator: 2 Drug: Placebo
Capsules

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00565760

Locations
United States, California
Advanced Clinical Research Institute
Anaheim, California, United States, 92801
United States, Maryland
Chesapeake Research Group
Pasadena, Maryland, United States, 21122
United States, Pennsylvania
Advanced Regional Center for Foot and Ankle Care
Altoona, Pennsylvania, United States, 16602
United States, Texas
Scirex Research Center
Houston, Texas, United States, 77081
United States, Utah
Lifetree Clinical Research
Salt Lake City, Utah, United States, 84106
Jean Brown Research
Salt Lake City, Utah, United States, 84124
Sponsors and Collaborators
QRxPharma Inc.
Investigators
Study Director: Warren Stern, Ph.D. QRxPharma Inc.
  More Information

No publications provided

Responsible Party: QRxPharma Inc.
ClinicalTrials.gov Identifier: NCT00565760     History of Changes
Other Study ID Numbers: Q8003-010
Study First Received: November 28, 2007
Last Updated: May 15, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by QRxPharma Inc.:
Acute
Pain

ClinicalTrials.gov processed this record on April 17, 2014