Safety and Efficacy Study of Oral XIGO Tablets to Treat The Common Cold

NCT01092039 | Completed DMC

• 1 other identifier: XIGO-001
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Common Cold

Keywords

Common Cold; Cold Virus; Feeling sick; Influenza

Outcome Measures

Primary Outcomes (1)

• Severity of cold symptoms over 7 days.

  The primary outcome measure will be to assess the severity of the typical interrelated common cold symptoms, over the first seven days of observation period, with the first day being the 24 hour period after first dose of treatment, using the patient/subject completion of the Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21).

  7 days post dose

Secondary Outcomes (3)

• Severity of Cold Symptoms over 14 days

  Over 14 day observation period

• Assess time to resolution

  14 days post dose

• Percentage of patients with unresolved symptoms

  14 days post dose

Study Arms (2)

XIGO pill

EXPERIMENTAL

Oral Xigo tablet

Dietary Supplement: lactoferrin, L-Glutamine and beta-glucans

Placebo

PLACEBO COMPARATOR

Oral placebo tablet

Dietary Supplement: lactoferrin, L-Glutamine and beta-glucans; Dietary Supplement: Placebo Comparator

Interventions

lactoferrin, L-Glutamine and beta-glucans DIETARY_SUPPLEMENT

Subject will be given XIGO pills or placebo. two tablets to be taken by mouth 3 times per day.

Placebo; XIGO pill

Placebo Comparator DIETARY_SUPPLEMENT

Subject will be given placebo comparator of two tablets to be taken by mouth 3 times per day.

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Xigo Health LLC: lead

Study Sites (1)

Neccr/Imca Llc

Fall River, Massachusetts, 02720, United States

Location

MeSH Terms

Conditions

Common Cold; Nausea; Influenza, Human

Interventions

Lactoferrin; Glutamine; beta-Glucans

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Orthomyxoviridae Infections

Intervention Hierarchy (Ancestors)

Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Glycoproteins; Glycoconjugates; Carbohydrates; Transferrins; Iron-Binding Proteins; Carrier Proteins; Proteins; Amino Acids, Peptides, and Proteins; Lactoglobulins; Whey Proteins; Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Globulins; Metalloproteins; Amino Acids, Basic; Amino Acids; Amino Acids, Diamino; Amino Acids, Neutral; Glucans; Polysaccharides

Study Officials

• Gregory G Allen J.R., D.O.

  NECCR/ IMCA LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 22, 2010
• First Posted: March 24, 2010
• Study Start: March 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: April 1, 2011
• Last Updated: July 24, 2012

Record last verified: 2011-06

Locations

US (1)