CLINICAL TRIALS PROFILE FOR MS CONTIN
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All Clinical Trials for Ms Contin
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00003687 ↗ | Treatment for Chronic Pain in Patients With Advanced Cancer | Completed | NCIC Clinical Trials Group | Phase 3 | 1998-06-11 | RATIONALE: Different drug formulations and combinations of drugs may help patients with chronic pain live more comfortably. It is not yet known which regimen is most effective for chronic pain. PURPOSE: Randomized phase III trial to compare the effectiveness of different morphine formulations with or without dextromethorphan in treating chronic pain in patients who have advanced cancer. |
| NCT00009672 ↗ | Pain Treatment for Sciatica | Completed | National Institute of Dental and Craniofacial Research (NIDCR) | Phase 2 | 2001-01-30 | This study will test the effectiveness of two drugs-nortriptyline and MS Contin (a type of morphine)-to treat pain caused by lumbar radiculopathy, or sciatica. Sciatica results from damage to the lumbar nerve roots, typically causing back pain and sharp, shooting pain down one or both legs. Although sciatica is common, there are no good treatments for it. Tricyclic antidepressants, such as nortriptyline, and opioids, such as morphine, have been effective in treating other kinds of pain from nerve damage. Patients between 18 and 65 years of age who have had sciatica pain daily for at least 3 months may be eligible for this study. Participants will provide a medical history and occupational and other social information. They will undergo a neurological examination, routine blood tests and an electrocardiogram and will fill out three questionnaires providing information on daily functioning and psychological well-being. This "cross-over" study consists of several parts, including a baseline study and four different treatment regimens. During each part, patients keep a daily log in which they rate their pain, record other procedures they undergo, such as injections and manipulations, and record medication side effects. In the first week of the study, patients remain on their current medications. Any antidepressants or opioids are stopped gradually before starting the drug trials. After the first week, patients go through the following four drug trials in random order: 1. Nortriptyline and inert placebo-Patients take nortriptyline in doses ranging from 25 mg. to 100 mg. and an inert placebo for morphine. (An inert placebo is a dummy pill; it looks like the test drug but has no active ingredient.) 2. MS Contin (morphine) and inert placebo-Patients take MS Contin in doses ranging from 30 mg. to 90 mg. and an inert placebo for nortriptyline. 3. Nortriptyline and MS Contin-Patients take MS Contin and nortriptyline in the same dose ranges as for each drug alone. 4. Active placebo and inactive placebo-Patients take an active placebo-in this case benztropine-and an inert placebo. An active placebo is a drug that does not work for the problem being studied but whose side effects are like those of the test drug-in this case, slight sleepiness or dry mouth. Benztropine is given at one-third the recommended dosage. For each drug regimen, the medication dose is increased gradually over 5 weeks until the maximum tolerated dose is reached. At the end of each regimen, patients are taken off the study drugs over a 12-day tapering period and are off drugs completely for another 2 days. Patients are seen by a doctor or nurse at the 7-week point in each study period. After all the drug trials are finished, patients repeat the questionnaires they filled out at the beginning of the study. Patients and their doctors will be informed of the medications that were effective in each individual's care. |
| NCT00288769 ↗ | Oral Vitamin B12 as Potential Treatment of Recurrent Aphthous Stomatitis | Completed | Soroka University Medical Center | N/A | 2006-03-01 | Background: Recurrent aphthous stomatitis is a common phenomenon in Primary Medicine.Frequency of the phenomenon can be as high as 25% of the general population and the recurrence of the problem can be up to 50%.Different approaches for treatment are described: treatment with various natural vitamins , local ointments , disinfectant agents for local treatment , local antibiotic ointments , NSAID, local cortisone-steroids , and even medication on the basis of immune-depressants of the immune system and systematic steroids . Methods: A double-blind study of daily administration of sublingual Vitamin B12 tablets manufactured by Solgar (each tablet containing 1000 mcg. of Vitamin B12) opposed to placebo tablets. Purpose of the research: To investigate the effect of Vitamin B12 on the frequency of recurrent canker sores of the mouth (RAS). Study hypothesis: Treatment with vitamin B12 will reduce the recurrence rate and will diminish the symptomatology of RAS episodes. |
| NCT00737737 ↗ | Hormone Function in Men Treated for Pain With Opioids or Placebo | Completed | National Institute of Nursing Research (NINR) | Phase 4 | 2008-08-01 | This study will examine hormone function in men with osteoarthritis pain and how it is affected by opioid medication (such as Percocet, Vicodin, MS Contin and morphine) versus placebo. Men between 30 and 65 years of age who have had moderate to severe osteoarthritis joint pain at least 5 days a week over the past 3 months may be eligible for this study. Candidates are screened with a physical examination, x-rays, laboratory and other tests, and questionnaires about pain, mood and medical health. They are given a pain diary to complete for 2 weeks. Participants are admitted to the hospital for two 12 hour overnight stays, during each of which they provide a 24-hour urine collection and have a small blood sample drawn every 20 minutes for 12 hours (from 8:00 p.m. to 8:00 a.m.) through a catheter that remains in place in a vein. Blood pressure and pulse are monitored during this time. After the catheter is removed, subjects complete questionnaires about their pain, mood and activity. For the several weeks between the two hospitalizations, subjects take either an opioid medication or placebo, or standard medication such as motrin and naprosyn, according to random assignment to one of the three groups. All participants will be allowed to take anti-inflammatory medications and acetaminophen during this time as needed, but no other pain medications or treatments. They are monitored two or three times a week by telephone and complete a pain diary. After the second hospitalization, subjects are tapered off the study medication. After 2 to 4 weeks of stopping medication, they return for a final outpatient visit to review pain or other medical problems and to have blood drawn. |
| NCT01665209 ↗ | Bioequivalence Study of Morphine Sulfate 60 mg Extended-Release Tablets Under Fed Conditions | Completed | Ranbaxy Inc. | Phase 1 | 2006-10-01 | The study was to evaluate the relative bioavailability of morphine and morphine-6-glucuronide from 2 tablet products and determine if the 2 products were bioequivalent to each other. |
| NCT01665222 ↗ | Bioequivalence Study of Morphine Sulfate 60 mg Extended-Release Tablets Under Fasting Conditions | Completed | Ranbaxy Inc. | Phase 1 | 2006-10-01 | The study was to evaluate the relative bioavailability of morphine and morphine-6-glucuronide from 2 tablet products and determine if the 2 products were bioequivalent to each other. |
| NCT01734252 ↗ | Argatroban in Critically Ill Patients With Heparin Resistance | Completed | Medical University Innsbruck | Phase 2 | 2012-07-29 | Critically ill patients with high risk for thrombosis or tromboembolic events with the presence of heparin resistance, treated at the Department for General and Surgical Critical Care Medicine of the Medical University Innsbruck, Austria will be enrolled in the study when meeting the inclusion- and exclusion criteria. If a patient meets the inclusion criteria and is recruited for the study, the patient will be randomized either to Group A or Group H. All patients have to achieve a prophylactic aPTT-target range of an aPTT-level of 45 - 60 sec (Pathromtin® SL) within 6 to 8 hours. Randomisation Group A: If a Heparin resistance appears and the patient meets the inclusion and exclu-sion criteria, he/she will be enrolled. The Heparin administration will be stopped and Argatroban will be given and adjusted until the target aPTT-range is achieved. Randomisation Group H - Standard therapy: If a Heparin resistance appears and the patient meets the inclusion and exclu-sion criteria, he/she will be enrolled. The Heparin administration will be contin-ued and, if necessary increased. Hereby the maximum heparin dose is 1.500 IU per hour. Therapy failure Group H: Primary target failure at Visit 3 (6-8 hours): If a patient of Group H does not achieve the target-aPTT within 6-8 hours, he/she will switch to Group A and will start with T1 (Baseline) and will follow the visits according to Group A until the final Visit 9 (T1 / day 30). Maintenance failure after Visit 3: Maintenance failure after 6-8 hours is defined as non-maintenance of the tar-get-aPTT until day 7 with a max. heparin dosage of 1.500 IU per hour. In this case, heparin therapy has to be changed to Argatroban. The patient will start with T1 (Baseline) and will follow the visits according to Group A until the final Visit 9 (day 30) counting from the Baseline of Group A. Therapy failure Group A: If a patient of Group A does not achieve the target-aPTT within 6-8 hours or cannot maintain the target-aPTT in spite of reaching the maximum dosage of 10µg/kg/min during the further study period, the patient automatically drops out of the study. The same is effective for patients who switched to the Group A after a therapy failure in Group H. General: Two hours after starting the Baseline investigations, patient's parameters in-cluding blood collections will be measured for the second time (T2). Additional measurements will be made at 6-8 hours (T3), 24 hours (T4), 48 hours (T5), 5 days (T6) after start of study drug and on day 7 before (T7) stop of study medication and 6h (T8) after stop of study medication. 30 days after inclusion in the study, a final investigation is planned (T9). |
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