Safety and Efficacy Study of Oral XIGO Tablets to Treat The Common Cold
Completed · Not applicable · Has a placebo group
Conditions studied: Common Cold
In brief
The purpose of the study will be to assess the efficacy and safety of XIGO administered orally, three times a day, compared with placebo in patients with the common cold.
Key facts
- Study ID
- NCT01092039
- Run by
- Xigo Health LLC
- People needed
- 140
- Starts
- 2010-03-01
- Expected to finish
- 2011-04-01
- Last updated by the study team
- 2012-07-24
Who can join
Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Must be in good health in the clinical judgment of the investigator, other than cold symptoms
- Must have a cumulative score of 2 or higher, but not larger than 6, with symptom severity rated as 0=absent, 1=mild, 2= moderate, or 3=severe for each of the eight symptoms: sneezing, nasal discharge, nasal obstruction, sore throat, cough, headache, malaise and chillness. At least one of the first four "cold specific" symptoms must be present, and none of these symptoms can have been present for more than 12 hours.
- Must enter trial within 12 hours of symptoms onset.
- Aged 18-50 years, (inclusive), at visit 1.
- Subjects must understand and sign and date an informed consent form prior to any study related procedures being performed.
- Subjects must be capable of understanding and following directions.
You may not qualify if…
- Subjects taking medications, other than birth control, which, in the opinion of the investigator, could influence the purpose, integrity or outcome of the trial.
- Pre-menopausal women (last menstruation <=1 year prior to ICF) who are nursing or pregnant or are of child-bearing potential and, in the opinion of the investigator, are not practicing an acceptable method of birth control, or do not plan to continue using method throughout the study.
- A history of adverse reactions to OTC drugs or other personal care products.
- Subjects who have used systemic steroids for at least 6 weeks prior to trial initiation or during the trial.
- A medical history of autoimmune disease, including Type 1 or Type 2 diabetes or HIV.
- Treatment with immunosuppressive drugs with the exception of cyclosporine for keratitis sicca.
Where it is running
- Neccr/Imca Llc — Fall River, Massachusetts, United States
Full record on ClinicalTrials.gov
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