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A Clinical Trial of KT07 Capsule in the U.S.A

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ClinicalTrials.gov Identifier: NCT02867358
Recruitment Status : Recruiting
First Posted : August 15, 2016
Last Update Posted : February 28, 2018
Sponsor:
Information provided by (Responsible Party):
Yiling Pharmaceutical Inc.

Brief Summary:
The purpose of this study is to investigate clinical efficacy of KT07 capsule in alleviation of fever and other symptoms including nasal congestion, sore throat, cough, aches and pains, fatigue, headache, chills or sweats in subjects with acute uncomplicated influenza.

Condition or disease Intervention/treatment Phase
Influenza, Human Drug: KT07 Capsule Other: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multi-center, Randomized, Double-blind, and Placebo-controlled Phase II Clinical Study to Investigate the Safety and Efficacy of Two Doses of KT07 Compared to Placebo in Subjects With Acute Uncomplicated Influenza
Study Start Date : September 2016
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Active Comparator: High dose of KT07 capsule
It will assess about 140 subjects with influenza at high dose KT07 (6 capsules each time, bid).
Drug: KT07 Capsule
Other Name: Lianhua Qingwen Capsule

Active Comparator: Low dose of KT07 capsule
It will assess about 140 subjects with influenza at low dose KT07 (4 capsules of KT07 + 2 capsules of placebo each time, bid).
Drug: KT07 Capsule
Other Name: Lianhua Qingwen Capsule

Other: Placebo
Placebo Comparator: Placebo
It will assess 140 subjects with influenza using 6 capsules of placebo each time, bid as control.
Other: Placebo



Primary Outcome Measures :
  1. To investigate the improvement in reducing the duration of illness compared to placebo. [ Time Frame: Up to 19 days ]

    Duration of illness is defined as: the length of time to alleviation of all symptoms.

    The duration of alleviation is calculated from time 0 (first administration of study medication) to the time at which symptom is alleviated.



Secondary Outcome Measures :
  1. The reduction in duration of alleviation of individual symptom [ Time Frame: Up to 19 days ]
    From time zero to the time at which the symptom is less than or equal to mild and stable for at least 24 hours

  2. Quality of life assessment [ Time Frame: Up to 19 days ]
    Based on the self-assessment questionnaire


Other Outcome Measures:
  1. Duration of viral shedding [ Time Frame: At day 3 and day 6 ]
    Use RT-PCR and TCID50 assay to quantitate virus load



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects with mild or moderate acute uncomplicated influenza with oral temperature of 37.3-39.3℃ (99.1-102.8°F); plus at least one respiratory symptom (nasal congestion, sore throat or cough); and at least one constitutional symptoms (aches and pains, fatigue, headache and chills or sweats).
  2. Subjects with Rapid Influenza Diagnostic Test (RIDT) confirmed influenza infection.
  3. Onset of symptoms less than 48 hours before Visit 1 (Screening; study drug administration visit) and receiving no antiviral/anti-influenza medication.
  4. Age 18 to 65 years old.
  5. Subjects who are able to understand and are willing to sign the informed consent form (ICF).
  6. All female subjects of child-bearing potential must have a negative urine pregnancy test result. All female subjects of child-bearing potential and male subjects and their spouse/partner must agree to use a medically acceptable method of contraception (e.g., abstinence, an intrauterine device, a double-barrier method such as condom + spermicide or condom + diaphragm with spermicide, a contraceptive implant, an oral contraceptive or have a vasectomised partner with confirmed azoospermia) throughout the entire study period and for 30 days for female and 90 days for male subjects after study drug discontinuation.

Exclusion Criteria:

  1. Subjects who suffer from severe influenza with oral temperature of more than 39.3℃ (102.8°F) with or without other symptoms.
  2. Subjects who have any of the following documented conditions: Subjects with hypertension and diabetes; lower respiratory tract infection other than influenza, asthma requiring daily therapy, including acute flare of chronic asthma, bronchial asthma, chronic obstructive pulmonary disease (COPD), acute infectious disease, any other chronic respiratory disease, bacterial infection of respiratory system, such as: suppurative tonsillitis, acute tracheobronchitis, sinusitis, otitis; subjects with history of moderate to severe cardiac, hepatic, renal and hematopoietic disorders, bleeding tendency or hemorrhagic disease, mental and neurological system disease; subjects with hyperthyroidism and increased intraocular pressure; and subjects with current cancer.
  3. Subjects with anatomical nasal obstruction or gross anatomical abnormalities. For example, nasal polyps or significant nasal septal deviation.
  4. Subjects who have to take other medications for the treatment of influenza or related symptoms, including but not limited to antipyretic and analgesic medicines (within 8 hours prior to randomization), antibiotics, and antiviral drugs.
  5. Subjects with acute dyspnea, wheezing, or moist rales on screening examination.
  6. Clinically very excessively obese subjects with BMI ≥40.
  7. Subjects with recent history (within 1 year) of alcoholism or substance abuse.
  8. Received influenza vaccine within 21 days.
  9. Participation in other clinical trial within 1 month, or during the study.
  10. Pregnant or breast-feeding female subjects.
  11. Allergy or known allergy to components of study medication.
  12. Allergy to aspirin or non-steroid anti-inflammatory drugs (NSAIDs), such as ibuprofen.
  13. Subjects who took a monoamine oxidase inhibitor (MAOI) within 2 weeks prior to enrollment.
  14. Subjects received antipyretic and/or analgesic medications for conditions other than influenza such as back pain within 8 hours prior to randomization.
  15. Administration of immunomodulators, interferon inducers, homeopathic, hormonal other than hormone replacement therapy, antiviral and antibacterial drugs during last 4 weeks before the first dose.
  16. Previous history of difficulty swallowing capsules.
  17. Any other associated disease or condition which, in the opinion of the investigator, might restrict or impede participation in the study or affect the study results.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02867358


Contacts
Contact: Nan Zhang, PhD 614-441-7888 zhangnan@yilingus.net

  Show 38 Study Locations
Sponsors and Collaborators
Yiling Pharmaceutical Inc.
Investigators
Study Chair: Xuedong Gao, MD Yiling Pharmaceutical Inc.

Responsible Party: Yiling Pharmaceutical Inc.
ClinicalTrials.gov Identifier: NCT02867358     History of Changes
Other Study ID Numbers: KT07-US-01
First Posted: August 15, 2016    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yiling Pharmaceutical Inc.:
acute uncomplicated influenza

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases