Trial Outcomes & Findings for Efficacy of Diclofenac Potassium Versus Acetaminophen in Febrile Children With Acute Upper Respiratory Tract Infections (NCT NCT01019980)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

2 participants

Primary outcome timeframe

2 hours

Results posted on

2012-11-19

Participant Flow

2 participants entered the study but did not receive drug because drug was not available in the region. The study was then terminated.

Participant milestones

Participant milestones
Measure	Diclofenac Potassium This study was cancelled. Two patients were enrolled, but neither received drug as it was not available in the region	Acetaminophen This study was cancelled. No patients were enrolled in this group.
Overall Study STARTED	2	0
Overall Study Discontinued	2	0
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Diclofenac Potassium This study was cancelled. Two patients were enrolled, but neither received drug as it was not available in the region	Acetaminophen This study was cancelled. No patients were enrolled in this group.
Overall Study Drug not available.	2	0

Baseline Characteristics

Efficacy of Diclofenac Potassium Versus Acetaminophen in Febrile Children With Acute Upper Respiratory Tract Infections

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: 2 hours

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 hours

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 hours

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 hours

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 hours

Outcome measures

Outcome data not reported

Adverse Events

Diclofenac Potassium

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Acetaminophen

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Results disclosure agreements

Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
Publication restrictions are in place

Restriction type: OTHER