A Study of Flurbiprofen 8.75 mg Lozenge in Patient With Pharyngitis

Reckitt Benckiser

Status and phase: Completed; Phase 3

Conditions: Pharyngitis

Treatments: Drug: Placebo; Drug: Flurbiprofen

Study type: Interventional

Funder types: Industry

Identifiers

NCT01049334

TH 0901

Details and patient eligibility

About

The purposes of this study is to demonstrate the analgesic efficacy of flurbiprofen 8.75 mg lozenge compared to its vehicle lozenge and to demonstrate the safety of the flurbiprofen lozenge throughout the course of treating sore throat due to acute pharyngitis.

Enrollment: 204 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. The patient has a complaint of sore throat.
2. If the patient is a female of childbearing potential, she has been using effective contraception since the last date of menses and is not breast-feeding or lactating.
3. If the patient is a female of childbearing potential, the patient must have a negative urine pregnancy.
4. The patient has provided written informed consent prior to any study-related procedures.

Exclusion criteria

1. The patient has a history of an upper gastrointestinal ulcer within the past 60 days, is currently experiencing clinically significant upper gastrointestinal complaints, or is currently taking medication regularly (≥ three times in the previous week).
2. The patient has a history of any hepatic disease or renal dysfunction.
3. The patient has a history of chronic analgesic use (≥ three times per week over the prior four weeks). (Patients on low-dose aspirin therapy may be allowed in the study per investigator's clinical decision.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

204 participants in 2 patient groups, including a placebo group

flurbiprofen 8.75 mg lozenge

Experimental group

Description:

Participants sucked flurbiprofen 8.75mg lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.

Treatment:

Drug: Flurbiprofen

Placebo lozenge

Placebo Comparator group

Description:

Participants sucked vehicle placebo lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.

Treatment:

Drug: Placebo