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CLINICAL TRIALS PROFILE FOR MORPHINE SULFATE

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505(b)(2) Clinical Trials for Morphine Sulfate

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

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Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Dosage	NCT00266786	Safety and Efficacy of Multiple Doses of Intranasal Ketorolac in Postoperative Pain Following Major Abdominal Surgery	Completed	Luitpold Pharmaceuticals	Phase 3	2005-12-01	Ketorolac has been marketed for several years in other forms (tablet and injectable) for the short-term relief of pain. This study will test whether a new dosage form (nasal spray) containing ketorolac is effective at relieving the pain of major abdominal surgery, and will also assess product safety. Previous studies with the nasal spray have suggested that it is similar to the previously approved injectable form in effectiveness for pain relief and in its safety profile. Patients will be randomized in a 2:1 ratio to receive intranasal ketorolac or placebo when their pain reaches a moderate level (40 on a scale of 100) following surgery. After the first dose, patients will receive study drug every 6 hours for 48 hours, and then as needed (up to 4 times a day) for a total of 5 days. If pain is not adequately relieved by the study drug, patients will be given morphine sulfate or other standard analgesics. Follow-up safety evaluations will occur about 1 and 2 weeks after the start of dosing. Patients will be asked to answer questions about their pain relief and any possible side effects of the drug during the study, and will be given physical examinations, including nasal evaluations, before and during the clinical trial. A small amount of blood will be drawn for routine clinical laboratory testing.
>Trial Type	>Trial ID	>Title	>Status	>Sponsor	>Phase	>Start Date	>Summary

All Clinical Trials for Morphine Sulfate

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Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00020618	Inhaled Morphine Compared With Morphine By Mouth in Treating Cancer Patients With Breakthrough Pain	Completed	Dana-Farber Cancer Institute	Phase 2	2001-03-01	RATIONALE: Morphine that is inhaled may be more rapidly absorbed than morphine that is given by mouth. It is not yet known if inhaled morphine is more effective than morphine given by mouth in relieving breakthrough pain. PURPOSE: Randomized phase II trial to compare the effectiveness of inhaled morphine with that of morphine given by mouth in treating cancer patients who have breakthrough pain.
NCT00132392	ALGRX 4975 After Total Knee Replacement	Completed	AlgoRx Pharmaceuticals	Phase 2	2005-07-01	ALGRX 4975 or placebo will be dripped onto the cut muscles and soft tissues before the end of surgery for total replacement of the knee. Each subject will undergo a screening visit; a hospitalization, during which total replacement of the knee will be performed; and follow-up visits at 2, 6, and 12 weeks after surgery. In addition, once discharged, subjects will be contacted by telephone daily up to Day 14. Subjects will complete pain and medication diaries during the first 2 weeks following surgery and will return these diaries at the 2 week visit. Starting on the afternoon of Day 0 (the day of surgery), pain on active range of motion (ROM) of the operated knee will be measured each morning at 8 AM ± 2 hours and each afternoon at 3 PM ± 3 hours. In addition, if the subject ambulates, pain with ambulation will be measured during the first ambulation in the morning and during the first ambulation after noon. Subjects will complete the Brief Pain Inventory - Short Form (BPI-SF) preoperatively, and at the 2, 6, and 12 week visits. Subjects will be questioned regarding the use of assistive devices (cane, walker, wheelchair, bedside commode, or other assistive devices) at screening, at discharge, and at the 2, 6, and 12 week visits. The active ROM on flexion of the knee, measured using a goniometer, will be recorded at screening and at the 2 week visit. Sensory mapping of the knee will be performed at screening and at the 12 week visit.
NCT00266786	Safety and Efficacy of Multiple Doses of Intranasal Ketorolac in Postoperative Pain Following Major Abdominal Surgery	Completed	Luitpold Pharmaceuticals	Phase 3	2005-12-01	Ketorolac has been marketed for several years in other forms (tablet and injectable) for the short-term relief of pain. This study will test whether a new dosage form (nasal spray) containing ketorolac is effective at relieving the pain of major abdominal surgery, and will also assess product safety. Previous studies with the nasal spray have suggested that it is similar to the previously approved injectable form in effectiveness for pain relief and in its safety profile. Patients will be randomized in a 2:1 ratio to receive intranasal ketorolac or placebo when their pain reaches a moderate level (40 on a scale of 100) following surgery. After the first dose, patients will receive study drug every 6 hours for 48 hours, and then as needed (up to 4 times a day) for a total of 5 days. If pain is not adequately relieved by the study drug, patients will be given morphine sulfate or other standard analgesics. Follow-up safety evaluations will occur about 1 and 2 weeks after the start of dosing. Patients will be asked to answer questions about their pain relief and any possible side effects of the drug during the study, and will be given physical examinations, including nasal evaluations, before and during the clinical trial. A small amount of blood will be drawn for routine clinical laboratory testing.
NCT00269737	Efficacy of the Fentanyl Transdermal Therapeutic System (TTS) in the Management of Pain in Patients With Cancer	Completed	Alza Corporation, DE, USA	Phase 3	1986-05-01	The purpose of this study is to evaluate the safety and effectiveness of continuous use of TTS fentanyl (a transdermal patch delivering the narcotic pain reliever fentanyl) for the treatment of chronic cancer pain.
NCT00314340	A Comparison of the Addiction Liability of Hydrocodone and Sustained Release Morphine	Completed	University of California, Davis	Phase 4	2005-11-01	Characterize the relative abuse liability of a short versus a long acting opioid in chronic pain patients.
NCT00410540	A Study of OROS Hydromorphone HCL vs Morphine in Cancer Pain Patients.	Completed	Alza Corporation, DE, USA	Phase 3	1969-12-31	The purpose of this study was to demonstrate the clinical equivalence of hydromorphone and morphine (immediate-release [IR] and sustained-release [SR] formulations) using the "worst pain in the past 24 hours" item of the Brief Pain Inventory (BPI). The secondary objective of this study was to compare hydromorphone and morphine in the following variables: other pain measures, various questionnaires, and safety and tolerability variables.
NCT00410787	Safety and Tolerability of Long-term Administration of OROS Hydromorphone HCI (Slow Release) in Cancer Pain	Completed	Alza Corporation, DE, USA	Phase 3	1969-12-31	The primary purpose of this study was to characterize the pain control achieved with long-term repeated dosing of OROS hydromorphone (slow release) in patients with chronic cancer pain and the secondary purpose was to characterize the effects of pain on the patients' quality of life with long-term, repeated dosing of OROS hydromorphone (slow release) taken by patients with chronic cancer pain.
>Trial ID	>Title	>Status	>Sponsor	>Phase	>Start Date	>Summary