NCT00825656

Brief Summary

The purpose of this study is to demonstrate the equivalence of two homeopathic capsaicin containing nasal sprays (Sinol-M™ and Sinol) in patients with nasal congestion due to allergic rhinitis.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2008

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

January 19, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 21, 2009

Completed
Last Updated

January 23, 2009

Status Verified

January 1, 2009

Enrollment Period

4 months

First QC Date

January 19, 2009

Last Update Submit

January 21, 2009

Conditions

Allergic Rhinitis

Keywords

Allergic RhinitisCapsaicinHomeopathicSinolSinol-M

Outcome Measures

Primary Outcomes (1)

  • Daily Total Nasal Symptom Score (congestion, rhinorrhea, sneezing, nasal itching)

    twice daily for 28 days

Secondary Outcomes (1)

  • Number of sprays of study drug used

    twice daily for 28 days

Study Arms (2)

1

EXPERIMENTAL

Sinol-M

Drug: Sinol or Sinol-M nasal spray

2

ACTIVE COMPARATOR

Sinol

Drug: Sinol or Sinol-M nasal spray

Interventions

Sinol or Sinol-M nasal sprayDRUG

One spray in each nostril up to a maximum of 12 times / day on an "as needed" basis

Also known as: Capsaicin nasal spray
12

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Willing to participate as indicated by providing written informed consent
  • years of age or older, of any gender and any race
  • Have had a positive skin prick and/or intradermal test for a currently prevalent allergen within the past 5 years
  • A history of allergic rhinitis, for at least 2 years
  • Have undergone washout of all medications that could have an influence on the study
  • Willing and able to make required study visits
  • Able to follow instructions and record diary symptoms.
  • Free of significant anatomic abnormalities, infection, bleeding, and mucosal ulcerations on nasal examination
  • Have a TNSS between 4 and 12 averaged over the 7 days immediately prior to V2
  • Have an average individual score for nasal congestion greater than or equal to 2 over the 7 days immediately prior to V2.

You may not qualify if:

  • any concurrent disease that could interfere with the investigation or evaluation of the study medications such as: rhinitis medicamentosa or large obstructive nasal polyps
  • any other anatomic nasal deformity that could interfere with their participation in the study
  • asthma, with the exception of mild intermittent asthma
  • congestion that, in the opinion of the study investigator, could interfere with successful nasal drug administration/absorption (in either nostril)
  • use of systemic corticosteroids (oral, parenteral, intravenous, rectal) or inhaled or ocular corticosteroids within the last 30 days
  • be undergoing allergy immunotherapy, unless on a stable dosing regimen throughout the course of the study
  • Be using dermal potent or super-potent topical corticosteroids
  • any systemic disorder that could interfere with the evaluation of the study medication
  • hypersensitivity to the study drugs or any component thereof
  • history of drug or alcohol abuse that would interfere with participation in the study
  • history of severe, unstable, or uncontrolled cardiovascular, hepatic, renal and/or other diseases/illnesses that could be expected to interfere with the study
  • upper or lower respiratory infection within 14 days of Vist 2
  • acute sinusitis within 30 days of Visit 2
  • any history or evidence of nasolacrimal drainage system malfunction
  • Be planning to travel to an area significantly antigenically different for a substantial portion (more than 48 hours) of any given study week.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Allergy and Asthma

Wheaton, Maryland, 20902, United States

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Martha White, MD

    Institute for Allergy and Asthma

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 19, 2009

First Posted

January 21, 2009

Study Start

September 1, 2008

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

January 23, 2009

Record last verified: 2009-01

Locations

US(1)