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| Tracking Information | |||||
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| First Received Date ICMJE | December 4, 2007 | ||||
| Last Updated Date | July 9, 2009 | ||||
| Start Date ICMJE | June 2007 | ||||
| Estimated Primary Completion Date | June 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00568555 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effects of Low Dose Naltrexone in Fibromyalgia | ||||
| Official Title ICMJE | Effects of Low Dose Naltrexone in Fibromyalgia | ||||
| Brief Summary | Low Dose Naltrexone (LDN) has been reported anecdotally to reduce the symptoms of Fibromyalgia, a Chronic Multisystem Illness. The drug may work by regulating natural pain-reducing systems. In this study, we will administer both LDN and placebo to a small group of individuals with Fibromyalgia and Gulf War Syndrome, both Chronic Multisymptom Illnesses, to assess the drug's efficacy in treating the condition. |
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| Detailed Description | This study will be a placebo-controlled, double-blind, cross-over drug tria. Patients with Primary Fibromyalgia or Gulf War Syndrome will be recruited from the Stanford University Pain Management Center and the surrounding community. Participation in the study will cover 22 weeks. Participants will attend a laboratory session 12 times for progress checkups, and will complete daily measures of symptoms. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study | ||||
| Condition ICMJE |
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| Intervention ICMJE | Drug: Naltrexone | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 60 | ||||
| Estimated Completion Date | June 2010 | ||||
| Estimated Primary Completion Date | June 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:Currently suffering from moderate to severe Fibromyalgia or symptoms of Gulf War Syndrome Age 18-65. Not taking any opioid analgesic Not pregnant or planning to become pregnant. Exclusion Criteria:Any known allergy to naltrexone or naloxone. Actual or planned pregnancy. |
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| Gender | Both | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00568555 | ||||
| Responsible Party | Sean Mackey, Principal Investigator, Stanford University School of Medicine | ||||
| Study ID Numbers ICMJE | SU-10232007-756, 8948 | ||||
| Study Sponsor ICMJE | Stanford University | ||||
| Collaborators ICMJE | American Fibromyalgia Syndrome Association | ||||
| Investigators ICMJE |
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| Information Provided By | Stanford University | ||||
| Verification Date | July 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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