NCT01361399

Brief Summary

The purpose of this study is to investigate the analgesic efficacy of a single dose of a fixed combination of 500 mg Aspirin (Acetylsalicylic Acid) and 4 mg Lidocaine in adult patients with sore throat associated with a common cold in comparison to a single treatment with 500 mg Aspirin or 4 mg Lidocaine alone as well a Placebo (treatment without any active ingredient). The combination of Aspirin and Lidocaine in a single lozenge is expected to provide relief from sore throat pain by sequential action. A very fast inset of action will be achieved by the locally acting Lidocaine and a long duration of action will be achieved by the systemically acting Aspirin.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
1,088

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Nov 2004

Shorter than P25 for phase_3

Geographic Reach
2 countries

19 active sites

Status
completed

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

November 30, 2004

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2005

Completed
6 years until next milestone

First Submitted

Initial submission to the registry

May 25, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 26, 2011

Completed
Last Updated

October 18, 2023

Status Verified

October 1, 2023

Enrollment Period

6 months

First QC Date

May 25, 2011

Last Update Submit

October 16, 2023

Conditions

Common ColdPharyngitisTonsillitis

Keywords

Sore Throat

Outcome Measures

Primary Outcomes (3)

  • Sum of pain intensity differences SPID

    120 minutes

  • Pain intensity difference to baseline (PID12 min)

    12 minutes

  • Pain intensity difference to baseline (PID120 min)

    120 minutes

Secondary Outcomes (5)

  • Pain intensity difference to baseline (PID)

    3, 6, 12, 18, 24, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 and 240 minutes post dose

  • Total pain relief to baseline (TOTPAR)

    3, 6, 12, 18, 24, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 and 240 minutes post dose

  • Symptoms of common cold (headache, sinus pressure/pain, feverish discomfort, muscle aches and pain)

    60, 120, 180, and 240 minutes post dose

  • Overall assessment of treatment

    240 minutes

  • Assessment of safety and tolerability

    240 minutes

Study Arms (4)

Arm 1

EXPERIMENTAL
Drug: Acetylsalicylic acid (Aspirin, BAYE4465) & Lidocain

Arm 2

ACTIVE COMPARATOR
Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)

Arm 3

ACTIVE COMPARATOR
Drug: Lidocain

Arm 4

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Acetylsalicylic acid (Aspirin, BAYE4465) & LidocainDRUG

Single oral application of a fixed combination of Aspirin and Lidocain (as one lozenge)

Arm 1
Acetylsalicylic Acid (Aspirin, BAYE4465)DRUG

Single oral application of Aspirin (as lozenge)

Arm 2
LidocainDRUG

Single oral application of Lidocain (as lozenge)

Arm 3
PlaceboDRUG

Single oral application of Placebo (as lozenge)

Arm 4

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and females of at least 18 years of age
  • Onset of common cold within the last 3 days (12 to 72 hours)
  • History of at least 4 symptoms associated with URTI in the last 24 hours out of runny nose, stuffy nose, sneezing, wet cough, dry cough, sweating, earache, ear fullness, sinus pressure/pain, head heaviness, muscle aches and pains, feverish discomfort, chills, hoarseness, sore throat, scratchy throat and headache as documented in the history of URTI
  • Current sore throat confirmed by a score ≥ 6 on a 11-category vertical ordinal scale for sore throat pain
  • Findings that confirmed the presence of tonsillopharyngitis

You may not qualify if:

  • Pregnancy (i.e. positive pregnancy test at baseline)
  • Breastfeeding
  • History of hypersensitivity (allergic reaction) to ASA or any other NSAID
  • History of hypersensitivity (allergic reaction) to lidocaine
  • History or acute state of peptic ulceration or gastrointestinal bleeding
  • History of bleeding tendency
  • History of asthma
  • Clinical diagnosis of chickenpox or influenza
  • History or presence of severe liver or kidney disease
  • Intake of short-acting analgesics (e.g. ASA, paracetamol, ibuprofen, diclofenac) either as a single ingredient or as part of a combination cold product in the last 6 hours, or intake of long-acting analgesics (e.g. naproxen) in the last 12 hours, or intake of any other NSAID in the last 24 hours
  • Use of any local or systemic short-acting cough and cold preparation (e.g. decongestant or antihistaminic drug) in the last 12 hours
  • Use of any cough or sore throat lozenges/candies or any menthol-containing product (including mentholated tissues) in the last 6 hours
  • Current intake or requirement of any prescription medication for the current treatment of acute respiratory tract illness
  • Administration of anticoagulants in the last 7 days
  • Inability to breathe through the nose or a history of chronic mouth breathing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Unknown Facility

Mocow, 117574, Russia

Location

Unknown Facility

Moscow, 105064, Russia

Location

Unknown Facility

Moscow, 114765, Russia

Location

Unknown Facility

Moscow, 117321, Russia

Location

Unknown Facility

Moscow, 117342, Russia

Location

Unknown Facility

Moscow, 117393, Russia

Location

Unknown Facility

Moscow, 117418, Russia

Location

Unknown Facility

Moscow, 117421, Russia

Location

Unknown Facility

Moscow, 117485, Russia

Location

Unknown Facility

Moscow, 117513, Russia

Location

Unknown Facility

Moscow, 117588, Russia

Location

Unknown Facility

Moscow, 127299, Russia

Location

Unknown Facility

Novosibirsk, 630099, Russia

Location

Unknown Facility

Kiev, 02091, Ukraine

Location

Unknown Facility

Kiev, 02222, Ukraine

Location

Unknown Facility

Kiev, 02232, Ukraine

Location

Unknown Facility

Kiev, 03049, Ukraine

Location

Unknown Facility

Luhansk, 91011, Ukraine

Location

Unknown Facility

Luhansk, 91055, Ukraine

Location

MeSH Terms

Conditions

Common ColdPharyngitisTonsillitis

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsPicornaviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

  • Bayer Study Director

    Bayer

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2011

First Posted

May 26, 2011

Study Start

November 30, 2004

Primary Completion

May 28, 2005

Study Completion

May 28, 2005

Last Updated

October 18, 2023

Record last verified: 2023-10

Locations

UA(6)RU(13)