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1. Controlled Trial of Mifepristone in Gulf War Veterans With Chronic Multisymptom Illness
This study is currently recruiting participants.
Verified by Bronx Veterans Medical Research Foundation, Inc, June 2008
Sponsors and Collaborators: Bronx Veterans Medical Research Foundation, Inc
U.S. Army Medical Research and Materiel Command
Information provided by: Bronx Veterans Medical Research Foundation, Inc
ClinicalTrials.gov Identifier: NCT00691067
Purpose:
We propose to conduct placebo-controlled trial of the glucocorticoid receptor antagonist mifepristone in Gulf War
veterans (GWV) with chronic multisymptom illness (CMI) to examine its effects on physical and mental health and
cognitive functioning. In addition, we propose to examine whether HPA axis biomarkers or their response to mifepristone
are useful predictors of clinical response.
Condition
Intervention
Phase
Chronic Multisymptom Illness in Gulf War Veterans
Drug: mifepristone
Drug: placebo
Phase IV
ChemIDplus related topics: Mifepristone
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Crossover Assignment,
Efficacy Study
Official Title: A Randomized, Double-Blind Placebo-Controlled Crossover Trial of Mifepristone in Gulf War Veterans
With Chronic Multisymptom Illness
Further study details as provided by Bronx Veterans Medical Research Foundation, Inc:
Primary Outcome Measures:
change in the health components score of the veterans RAND 36-item health survey (VR-36) [ Time Frame: baseline,
every two weeks, endpoint ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
cognitive functioning and measures of depression, fatigue and PTSD [ Time Frame: baseline and endpoint ]
[ Designated as safety issue: No ]
Estimated Enrollment: 40
Study Start Date: May 2008
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Intervention Details:
Drug: mifepristone
200 mg po per day x 6 weeks
Drug: placebo
placebo
Eligibility
Ages Eligible for Study: 35 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria:
Veteran of the 1991 Gulf War
Veteran meets criteria for multisymptom illness
Exclusion Criteria:
Veteran lacks the capacity to provide consent.
Veteran has a major medical or neurological disorder or traumatic brain injury
Veteran has morning plasma cortisol level less than 5 mcg/dl or a history of adrenal insufficiency
Veteran has a fasting blood glucose = 110 mcg/dl
Veteran is taking oral corticosteroids
Veteran has a lifetime diagnosis of schizophrenia, schizoaffective disorder or bipolar disorder
Veteran has been psychiatrically hospitalized or attempted suicide within the previous 2 years
Veteran has current suicidal ideation
Veteran is pregnant or breastfeeding or plans to become pregnant within the year (male or female) not
willing to use appropriate forms of contraception during the study and for at least 90 days post treatment.
Women veterans with diseases of the uterus by history or a family history of uterine cancer
Known allergy to mifepristone
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00691067
Contacts
Contact: Julia A Golier, M.D. 718-584-9000 ext 5196 julia.golier@va.gov
Locations
United States, New York
James J Peters VA Medical Center Recruiting
Bronx, New York, United States, 10468
Contact: Julia A Golier, M.D. 718-584-9000 ext 5196 julia.golier@va.gov
Principal Investigator: Julia A Golier, M.D.
Sponsors and Collaborators
Bronx Veterans Medical Research Foundation, Inc
U.S. Army Medical Research and Materiel Command
Investigators
Principal Investigator: Julia A Golier, M.D. James J Peters VA Medical Center
More Information
Responsible Party: James J Peters VA Medical Center ( Julia Golier, M.D. )
Study ID Numbers: GW060048
First Received: June 3, 2008
Last Updated: June 4, 2008
ClinicalTrials.gov Identifier: NCT00691067
Health Authority: United States: Food and Drug Administration
2. Gulf War Digestive Health Study
This study is currently recruiting participants.
Verified by Department of Veterans Affairs, May 2008
Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00680836
Purpose
The purposes of this study are to estimate the burden of disease due to chronic gastrointestinal
illness in PG veterans, to evaluate whether SBBO is associated with chronic diarrhea in PG veterans,
and to determine whether eradication of SBBO reduces symptoms of chronic diarrhea, abdominal pain and
bloating in PG veterans.
Condition Intervention
Irritable Bowel Syndrome
Drug: Placebo
Drug: Rifaximin
MedlinePlus related topics: Diarrhea
ChemIDplus related topics: Rifaximin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor),
Placebo Control, Parallel Assignment, Efficacy Study
Official Title: Diarrhea-Predominant Irritable Bowel Syndrome in Persian Gulf Veterans
Further study details as provided by Department of Veterans Affairs:
Primary Outcome Measures:
Improvement in IBS Global Improvement Scale. [ Time Frame: once a month for the 6 months following
completion of medication ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
Change in Symptom Severity [ Time Frame: 6 months after medication regimine is completed ]
[ Designated as safety issue: No ]
Change in IBS-QOL Questionnaire [ Time Frame: 1 week after starting the medication,
2 weeks after starting the medication, 1 month after finishing medication, 6 months after finishing medication ]
[ Designated as safety issue: No ]
Change in LBT [ Time Frame: 6 months after completion of medication ] [ Designated as safety issue: No ]
Estimated Enrollment: 140
Study Start Date: October 2007
Estimated Study Completion Date: March 2009
Estimated Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: No Intervention
These patients do not have IBS. They may be deployed or non-deployed veterans.
2: Active Comparator
These patients have IBS and are receiving the rifaximin. Drug: Rifaximin
550 mg orally two times per day for 14 days
3: Placebo Comparator
These patients have IBS and are receiving the placebo. Drug: Placebo
orally two times per day for 14 days
Show Detailed Description
Eligibility
Ages Eligible for Study: 35 Years to 72 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: Yes
Criteria
Inclusion Criteria:
Men and women age 32-75 years
Rome III criteria for diarrhea-predominant IBS
Symptom onset after an apparent episode of acute gastroenteritis
Symptoms of > 3 months duration
Normal endoscopic appearance of the colonic mucosa
Negative markers for celiac disease and inflammatory bowel disease.
Normal thyroid function and serum calcium levels.
Must have served in the military or reserves during the time of Operation Desert Storm (August 1990 to May 1991)
Exclusion Criteria:
Clinically significant cardiac, pulmonary, hepatic or renal dysfunction
History of/or presence of systemic malignancy
Current evidence of any gastrointestinal disorder such as celiac disease or inflammatory bowel
disease (i.e. Crohns disease or ulcerative colitis)
Current effects of drug or alcohol abuse
Investigator perception of patients inability to comply with study protocol
Unstable psychiatric disease
Recent change in gastrointestinal medications
Subjects with a positive pregnancy test
Subject is currently participating in another research protocol that could interfere or influence the
outcome measures of the present study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00680836
Contacts
Contact: Karolyn Wright (801) 582-1565 ext 1993 karolyn.wright@va.gov
Locations
United States, Utah
Division of Epidemiology Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Karolyn Wright 801-582-1565 ext 1993 karolyn.wright@va.gov
Principal Investigator: Ashok K Tuteja, MD MPH
Sponsors and Collaborators
Department of Veterans Affairs
Investigators
Principal Investigator: Ashok K Tuteja, MD MPH Division of Epidemiology
More Information
Publications:
[No authors listed] Self-reported illness and health status among Gulf War veterans. A population-based study. The Iowa Persian Gulf Study Group. JAMA. 1997 Jan 15;277(3):238-45.
Fukuda K, Nisenbaum R, Stewart G, Thompson WW, Robin L, Washko RM, Noah DL, Barrett DH, Randall B, Herwaldt BL, Mawle AC, Reeves WC. Chronic multisymptom illness affecting Air Force veterans of the Gulf War. JAMA. 1998 Sep 16;280(11):981-8.
Sostek MB, Jackson S, Linevsky JK, Schimmel EM, Fincke BG. High prevalence of chronic gastrointestinal symptoms in a National Guard Unit of Persian Gulf veterans. Am J Gastroenterol. 1996 Dec;91(12):2494-7.
[No authors listed] Unexplained illnesses among Desert Storm veterans. A search for causes, treatment, and cooperation. Persian Gulf Veterans Coordinating Board. Arch Intern Med. 1995 Feb 13;155(3):262-8
Orskov F, Sack RB, Orskov I, Froelich JL. Changing fecal Escherichia coli flora during travel. Eur J Clin Microbiol. 1984 Aug;3(4):306-9.
Hyams KC, Bourgeois AL, Merrell BR, Rozmajzl P, Escamilla J, Thornton SA, Wasserman GM, Burke A, Echeverria P, Green KY, et al. Diarrheal disease during Operation Desert Shield. N Engl J Med. 1991 Nov 14;325(20):1423-8.
Camilleri M. Mechanisms in IBS: something old, something new, something borrowed... Neurogastroenterol Motil. 2005 Jun;17(3):311-6. No abstract available.
Singh VV, Toskes PP. Small Bowel Bacterial Overgrowth: Presentation, Diagnosis, and Treatment. Curr Treat Options Gastroenterol. 2004 Feb;7(1):19-28.
Spiller RC. Postinfectious irritable bowel syndrome. Gastroenterology. 2003 May;124(6):1662-71. Review.
Pimentel M, Chow EJ, Lin HC. Normalization of lactulose breath testing correlates with symptom improvement in irritable bowel syndrome. a double-blind, randomized, placebo-controlled study. Am J Gastroenterol. 2003 Feb;98(2):412-9.
Pimentel M, Soffer EE, Chow EJ, Kong Y, Lin HC. Lower frequency of MMC is found in IBS subjects with abnormal lactulose breath test, suggesting bacterial overgrowth. Dig Dis Sci. 2002 Dec;47(12):2639-43.
Pimentel M, Chow EJ, Lin HC. Eradication of small intestinal bacterial overgrowth reduces symptoms of irritable bowel syndrome. Am J Gastroenterol. 2000 Dec;95(12):3503-6.
Responsible Party: Department of Veterans Affairs ( Tuteja, Ashok - Principal Investigator )
Study ID Numbers: GWRA-014-05F, IRB#16469
First Received: May 16, 2008
Last Updated: May 16, 2008
ClinicalTrials.gov Identifier: NCT00680836
Health Authority: United States: Federal Government
3. Effects of Low Dose Naltrexone in Fibromyalgia
This study is currently recruiting participants.
Verified by Stanford University, April 2008
Sponsored by: Stanford University
Information provided by: Stanford University
ClinicalTrials.gov Identifier: NCT00568555
Purpose
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.
Condition Intervention
Fibromyalgia
Persian Gulf Syndrome
Drug: Naltrexone
MedlinePlus related topics: Fibromyalgia
ChemIDplus related topics: Naltrexone Naltrexone hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Single Blind, Placebo Control, Single Group Assignment, Efficacy Study
Official Title: Effects of Low Dose Naltrexone in Fibromyalgia
Further study details as provided by Stanford University:
Primary Outcome Measures:
Pain
Fatigue
Sleep quality
Secondary Outcome Measures:
Mechanical Pain Sensitivity
Thermal Pain Sensitivity
Estimated Enrollment: 60
Study Start Date: June 2007
Detailed Description:
This study will be a placebo-controlled, single-blind, pre-post drug trial. 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.
Eligibility
Ages Eligible for Study: 18 Years to 65 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00568555
Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Jarred Younger LDN_Younger@stanford.edu
Principal Investigator: Sean Mackey
Sub-Investigator: Jarred Younger
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Sean Mackey Stanford University
More Information
Study ID Numbers: SU-10232007-756, 8948
First Received: December 4, 2007
Last Updated: April 4, 2008
ClinicalTrials.gov Identifier: NCT00568555
Health Authority: USA:Office of Human Research Protection
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