NCT00229021 is a Phase 3 clinical trial of doripenum in Urinary Tract Infections, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..

Who is sponsoring NCT00229021?

NCT00229021 is sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..

What drugs are being tested in NCT00229021?

Interventions in NCT00229021: doripenum.

What condition does NCT00229021 study?

NCT00229021 studies Urinary Tract Infections, Pyelonephritis.

Is NCT00229021 still recruiting?

NCT00229021 is currently completed. Last updated 8 June 2011.

Last reviewed 2011-06-08 · How we verify

NCT00229021

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Multicenter, Double-Blind, Randomized, Phase 3 Study of Doripenem Verus a Comparator Antibiotic in the Treatment of Complicated Lower Urinary Tract Infection or Pyelonephritis

Completed Phase 3 Last updated 8 June 2011

What this trial tests

Phase 3 trial testing doripenum in Urinary Tract Infections in 741 participants. Completed in 1 March 2006.

Timeline

1 December 2003

1 March 2006

Quick facts

Lead sponsor	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	741
Start date	1 December 2003
Estimated completion	1 March 2006

Drugs / interventions tested

doripenum — full drug profile →

Conditions studied

Urinary Tract Infections — all drugs for Urinary Tract Infections →
Pyelonephritis — all drugs for Pyelonephritis →

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. — full company profile →

Who can join

18 and older, any sex, with Urinary Tract Infections or Pyelonephritis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Microbiological response measured at test of cure visit at early follow-up.

Sponsor's own description

The purpose of this study is to compare the microbiological cure rate of doripenem versus a comparator antibiotic in the treatment of patients with complicated urinary tract infection or pyelonephritis. The study will also characterize the safety and tolerability of treatment with doripenem in patients with complicated urinary tract infection or pyelonephritis.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Worldwide experience with the use of doripenem against extended-spectrum-beta-lactamase-producing and ciprofloxacin-resistant Enterobacteriaceae: analysis of six phase 3 clinical studies.
Kaniga K, Flamm R, Tong SY, Lee M, et al · · 2010 · cited 22× · PMID 20211892 · DOI 10.1128/aac.01450-09
Safety and efficacy of intravenous doripenem for the treatment of complicated urinary tract infections and pyelonephritis.
Redman R, Damiao R, Kotey P, Kaniga K, et al · · 2010 · cited 12× · PMID 21303745 · DOI 10.1179/joc.2010.22.6.384

Verify or expand the search:

Other recruiting trials for Urinary Tract Infections

Currently open trials in the same condition.

NCT06976125 — Application of a Prediction Model for Directing Antibiotic Use in the Treatment of Urinary Tract Infection in an Ambulat · NA · recruiting
NCT06808451 — Diagnosis and Treatment of Urinary Tract Infection Using DNA Polymerase Chain Reaction Versus Urine Culture · NA · recruiting
NCT07186465 — Microbiome-Modulating Prophylaxis RCT: Antibiotic vs Gynoflor in Postmenopausal Women With Recurrent Cystitis · Phase 4 · recruiting
NCT07207291 — Phase I Study of Single/Multiple Ascending Doses of JKN2501 for Injection in Chinese Healthy Volunteers · Phase 1 · recruiting
NCT06715306 — Intravenous Versus Oral Treatment of the Main Acute Infections · NA · recruiting

Other Johnson & Johnson Pharmaceutical Research & Development, L.L.C. trials

Trials by the same sponsor.

NCT04330248 — A Study of Steady-state Carbamazepine on the Single-dose of Erdafitinib Tablets in Healthy Adult Participants · Phase 1 · completed
NCT01094262 — A Safety and Tolerability Study of JNJ-42160443 in Patients With Moderate to Severe, Chronic Knee Pain From Osteoarthrit · Phase 2 · terminated
NCT01060254 — A Study to Evaluate the Pain Relieving Effects, Safety, and Tolerability of JNJ-42160443 for the Relief of Bladder Pain · Phase 2 · terminated
NCT00973141 — A Dose-ranging Study of the Safety and Effectiveness of JNJ-42160443 as add-on Treatment in Patients With Osteoarthritis · Phase 2 · terminated
NCT01756404 — Study to Assess the Pharmacokinetics, Pharmacodynamics, and Safety of Canagliflozin (JNJ-28431754) in Otherwise Healthy · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00229021 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Last refreshed: 8 June 2011

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00229021.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing