Acute Pain Clinical Trial
Official title:
A Phase III, Multi-Center, Open-Label, Prospective, Repeated Dose, Randomized, Controlled, Multi-Day Study of the Safety and Efficacy of Intravenous Acetaminophen in Adult Inpatients
Verified date | May 2015 |
Source | Mallinckrodt |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The study will be investigating safety and efficacy administration of repeated dose of IV Acetaminophen (IV APAP) over five days for the treatment of acute pain or fever in adult patients.
Status | Completed |
Enrollment | 213 |
Est. completion date | November 2008 |
Est. primary completion date | November 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 85 Years |
Eligibility |
Inclusion Criteria: - Provide written informed consent prior to participation in the Study - Be at least 18 years of age and weigh at least 41 kilogram (kg) - Be anticipated by the Investigator to require multi-day (target is five days) use of IV treatment either because of having a "nothing by mouth" (NPO) status having a medical condition that makes oral intake difficult having a medical condition that requires IV treatment - Be willing to undergo 5 days of treatment with IV acetaminophen for the treatment of pain or fever (defined as a core temperature greater than or equal to 38 degrees celsius). Note that Subjects have a slightly less than 15% chance (one in seven) of being assigned to the Control Group and receiving standard of care treatment, but no IV APAP. - Have the ability to read and understand the Study procedures and have the ability to communicate meaningfully with the Study Investigator and staff - If a female of child bearing potential, have a negative pregnancy test within 48 hours of randomization Exclusion Criteria: - Has a significant medical disease, laboratory abnormality or condition that, in the Investigator's judgment, could compromise the Subject's welfare or would otherwise contraindicate Study participation - Is expected to have difficulty in communicating with the Study staff or completing Study requirements (including follow up visits) - Has known hypersensitivity to acetaminophen or the inactive ingredients (excipients) of IV acetaminophen or any contraindication to receiving acetaminophen - Has impaired liver function, e.g., Alanine aminotransferase (ALT) greater than or equal to 3 times the upper limit of normal (ULN), bilirubin greater than or equal to 3 times ULN, known active hepatic disease (e.g., hepatitis), evidence of clinically significant chronic liver disease or other condition affecting the liver (e.g., alcoholism as defined by DSM-IV, cirrhosis or chronic hepatitis) - Has participated in an interventional clinical Study (investigational or marketed product) within 30 days of Study entry |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Arcadia Methodist Hospital | Arcadia | California |
United States | The Ohio State University Medical Center | Columbus | Ohio |
United States | Nature Coast Clinical Research | Crystal River | Florida |
United States | G&G Research | Fort Pierce | Florida |
United States | Glendale Adventist Medical Center | Glendale | California |
United States | Memorial Herman/Memorial City Hospital | Houston | Texas |
United States | Accurate Clinical Trials, Inc. | Laguna Hills | California |
United States | University of Miami School of Medicine | Miami | Florida |
United States | Weill Medical College of Cornell University | New York | New York |
United States | Huntington Memorial Hospital | Pasadena | California |
United States | Lotus Clinical Research, Inc. | Pasadena | California |
United States | Thomas Jefferson University | Philadelphia | Pennsylvania |
United States | Oregon Health Science University | Portland | Oregon |
United States | Santa Barbara Cottage Hospital | Santa Barbara | California |
Lead Sponsor | Collaborator |
---|---|
Mallinckrodt |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Subjects Reporting at Least One Treatment-Emergent Adverse Event (TEAE). | Number of subjects who experienced at least one treatment emergent adverse event (TEAE). A TEAE is an adverse event that occurs on or after the first dose of study medication (T0). |
T0 (first dose of IV APAP or randomization to SOC group) to Day 7 - 12 Follow-up | Yes |
Primary | Subjects Who Experienced at Least One Serious Treatment-Emergent Adverse Event (TEAE) | Serious TEAE is any untoward medical occurrences at any dose of study medication that: results in death is life threatening requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity is a congenital anomaly/birth defect is an important medical event |
First dose (T0) to within 30 days of the last dose of study medication. | Yes |
Secondary | Subject Global Evaluation of the Level of Satisfaction With Side Effects Related to Study Treatments | Using a four point categorical scale 0= poor, 1= fair, 2= good, 3= excellent, comparisons of subject's Global Evaluations of the level of satisfaction with side effects related to study treatment at End of Day 5 (prior to discharge) | End of Day 5 (prior to discharge) | No |
Secondary | Subject Global Evaluation of the Level of Satisfaction With Study Treatments Looking Back Over the Entire Treatment Period. | Using a four point categorical scale 0= poor, 1= fair, 2= good, 3= excellent, comparisons of subject's Global Evaluations of the level of satisfaction with study treatments looking back over the entire treatment period was conducted at Day 7. | Study period lookback at Day 7 | No |
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