Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00411307
Status:
COMPLETED
Last Update Posted:
2010-04-27
First Post:
2006-12-12
Brief Title:
A Randomized Open-Label Single-Dose Small Study to Evaluate the Safety and Effectiveness of Hydromorphone in Patients With Short Term Moderate to Severe Postoperative Pain
Sponsor:
Alza Corporation DE USA
Organization:
Alza Corporation DE USA
Study Overview
Official Title:
A Randomized Open-Label Single-Dose Pilot Study to Evaluate the Safety and Efficacy of OROS Hydromorphone in Patients With Acute Moderate-to-Severe Postoperative Pain
Status:
COMPLETED
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this small study was to investigate the safety and effectiveness of OROS hydromorphone HCI for the treatment of short-term moderate to severe postoperative pain following total knee replacement surgery
Detailed Description:
This was a multicenter randomized patients are assigned different treatments based on chance open-label single dose small study During the 36 hour study period concomitant analgesic pain medications and physical therapy were recorded in the patients case report form The study duration for each patient was 36 hours after a single dose of OROS hydromorphone HCI had been administered After surgery eligible patients had to tolerate liquids swallow a tablet and have audible bowel sounds Before OROS hydromorphone HCI was administered all analgesic medications were discontinued and patients with a pain score of 2moderate pain or 3 severe pain upon movement were eligible to enter the study and receive a single oral dose of OROS hydromorphone HCI Patients had to have stable heart rates blood pressure respiration oxygen saturation greater than or equal to 94 and patients who had undergone regional anesthesia had to have motor and sensory recovery from nerve blockade Qualifying patients were given OROS hydromorphone HCI between 6 and 48 hours after completion of the surgical procedure Patients were randomized into 3 groups OROS hydromorphone HCI 8 16 and 32 mg The precise time of OROS hydromorphone HCI administration was considered time zero To maintain consistency dosing was to occur between 6 am and 2 pm if possible Following study drug administration patients could be given rescue medication of oral hydromorphone immediate-release tablets 2 or 4 mg for breakthrough pain as needed Oxygen saturation vital signs pain relief ratings and pain intensity ratings at rest and upon movement were obtained at 2-hour time intervals during the first 8 hours following study drug administration and at 4 hour intervals from 8 to 36 hours following study drug administration The study concluded 36 hours after dosing at which time a global evaluation of pain relief was obtained from each patient One single dose of OROS hydromorphone HCI 8 16 or 32 mg administered orally at the beginning of the 36 hour study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None