EUCTR2004-001069-17-LTActive, not recruitingNot Applicable
A double-blind, active-controlled, randomized, multicenter, parallel-group 2 day comparison of 1000 mg propyphenazone / 80 mg codeine (applied as two suppositories) combination therapy versus a 1000 mg propyphenazone monotherapy (applied as two suppositories) in terms of safety and efficacy in patients suffering from urogenital or biliary pain
ovartis Pharma GmbH0 sites400 target enrollmentStarted: January 31, 2005Last updated:
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 400
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •? patients with at least moderate to severe urogenital or biliary pain (VAS > 60 mm), at least 18 years of age
- •? written informed consent prior to study medication
- •? indication for medicamentous therapy of the urogenital or biliary pain
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •? pregnancy or breast feeding
- •? female patients in childbearing age without medically approved method of contraception
- •? patients who had any spasmolytic or analgesic treatment because of the current urogenital or biliary pain before entry in the study
- •? known drug related allergies or hypersensitivity, especially towards one of the compounds of the study drugs or rescue medication (propyphenazone or codeine or metamizole)
- •? known allergy or hypersensitivity towards non-steroidal antiphlogistics or acetylsalicylic acid
- •? acute intermittent porphyria
- •? chronic constipation
- •? paralytic intestinal obstruction
- •? glucose-6-phosphase-deficiency
- •? patients with asthma or hay fever
- •? alcohol or drug abuse
- •? tachyarrhythmia
- •? hypotension
- •? intake of antidepressants, MAO-inhibitors, amantadines and neuroleptics, opiadagonists, pancuronium and vecuronium, centrally sedating pharmaceutics
- •? intake of other investigational drugs within the last 30 days before the participation of this trial
Investigators
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