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Efficacy and Safety Study of Amelior in Hospitalized Adult Orthopedic Patients
This study has been completed.
First Received: May 7, 2007   Last Updated: September 23, 2008   History of Changes
Sponsored by: Cumberland Pharmaceuticals
Information provided by: Cumberland Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00470600
  Purpose

The primary objective of this study of Amelior administered to post-operative hospitalized adult orthopedic patients every 6 hours for at least 24 hours is to determine the efficacy of Amelior compared to placebo for the treatment of post-operative pain by patients self-assessment of pain.


Condition Intervention Phase
Pain
Drug: Amelior
Phase III

U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Further study details as provided by Cumberland Pharmaceuticals:

Primary Outcome Measures:
  • Self-assessment of pain [ Time Frame: Seven Days ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: May 2007
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Placebo Comparator Drug: Amelior
800mg or placebo, IV
2: Experimental Drug: Amelior
800mg or placebo, IV

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Scheduled for elective hip or knee replacement, reconstruction or arthroplasty surgery with anticipated need for post-operative I.V. morphine analgesia with anticipated use of ≥ 28 hours.
  2. Adequate IV access
  3. Anticipated hospital stay ≥ 28 hours

Exclusion Criteria:

  1. Be unable to make a reliable self-report of pain intensity to pain relief
  2. Less than 18 years of age
  3. Greater than 80 years of age
  4. Use of analgesics, muscle relaxants, NSAIDS and sedatives less than 12 hours prior to CTM administration with the following exceptions: paracetamol (acetaminophen) can be administered until 6 hours prior to surgery; tramadol can be administered until midnight the evening prior to surgery; muscle relaxants working at the neuromuscular junction used for intubation and/or anesthesia administration for the surgical procedure prior to CTM administration; and sedatives (i.e., midazolam) used as a co-induction agent for the surgical procedure prior to CTM administration
  5. Patients taking warfarin, lithium, combination of ACE-inhibitors and furosemide
  6. Patients with anemia (active, clinically significant anemia) and/or a history or evidence of asthma or heart failure
  7. History of allergy or hypersensitivity to any component of Amelior, aspirin (or aspirin related products), NSAIDs, or COX-2 inhibitors
  8. Pregnant or nursing
  9. History of severe head trauma that required current hospitalization, intracranial surgery or stroke within the previous 30 days, or any history of intracerebral arteriovenous malformation, cerebral aneurysm or CNS mass lesion
  10. Weigh less than 30kg
  11. Have a history of congenital bleeding diathesis (eg hemophilia) or any active clinically significant bleeding, or have underlying platelet dysfunction including (but not limited to) idiopathic thrombocytopenic purpura, disseminated intravascular coagulation, or congenital platelet dysfunction
  12. Have GI bleeding that required medical intervention within the previous 6 weeks (unless definitive surgery has been performed)
  13. Have a platelet count less than 30,000mm3 determined within the 28 days prior to surgery
  14. Pre-existing dependence on narcotics or known tolerance to opioids
  15. Inability to understand the requirements of the study, be willing to provide written informed consent (as evidenced by signature on an informed consent document approved by an Institutional Review Board [IRB]), and agree to abide by the study restrictions and to return for the required assessments
  16. Refusal to provide written authorization for use and disclosure of protected health information
  17. Be on dialysis, have oliguria or creatinine greater than 3.0 mg/dL.
  18. Inability to achieve hemostasis or inability to close surgical incision, prior to Operating Room discharge
  19. Operative procedure includes organ transplant
  20. Pre or intra-operative procedure utilized for the prevention of pre- or post-operative pain (i.e. epidural or nerve blocks)
  21. Be receiving full dose anticoagulation therapy or Activated Protein C within 6 hours before dosing (Prophylaxis with subcutaneous heparin is acceptable)
  22. Have received another investigational drug within the past 30 days
  23. Be otherwise unsuitable for the study in the opinion of the investigator
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00470600

Locations
United States, Alabama
Wilmax Clinical Research Inc.
Mobile, Alabama, United States, 336608
United States, Arkansas
Teton Research, LLC
Little Rock, Arkansas, United States, 72205
United States, California
Clinical Management Services, Inc.
Arcadia, California, United States, 91007
United States, Georgia
Southeastern Center for Clinical Trials
Atlanta, Georgia, United States, 30350
United States, Texas
Research Concepts, Inc.
Houston, Texas, United States, 77401
Research Concepts, Inc
Houston, Texas, United States, 77054
South Africa
Eugene Marais Hospital
Pretoria, South Africa
Krugersdorp Private Hospital
Krugersdorp, South Africa
Johannesburg General Hospital
Johannesburg, South Africa
Sponsors and Collaborators
Cumberland Pharmaceuticals
  More Information

No publications provided

Responsible Party: Cumberland Pharmaceuticals Inc. ( Army Rock, Ph.D., Senior Manager, Regulatory Affairs )
Study ID Numbers: CPI-CL-008C
Study First Received: May 7, 2007
Last Updated: September 23, 2008
ClinicalTrials.gov Identifier: NCT00470600     History of Changes
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Pain

ClinicalTrials.gov processed this record on May 07, 2009