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

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2004-001069-17-LT
• Date of registration: 31/01/2005
• Prospective Registration: No
• Primary sponsor: Novartis Pharma GmbH
• Public title: 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
• Scientific title: 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
• Date of first enrolment: 16/09/2004
• Target sample size: 400
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-001069-17
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no

Countries of recruitment

Lithuania

Key inclusion & exclusion criteria

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
? coma
? 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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

acute, at least moderate to severe biliary or urogenital pain
MedDRA version: 7.0 Level: low Classification code 10004670

Intervention(s)

Trade Name: Cibalgin compositum N Zäpfchen (suppositories)
Product Name: Cibalgin compositum N Zäpfchen (suppositories)
Product Code: SPJ 135
Pharmaceutical Form: Suppository
INN or Proposed INN: Propyphenazone
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
INN or Proposed INN: Codeine phospat
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-

Product Name: Propyphenazone
Pharmaceutical Form: Suppository
INN or Proposed INN: Propyphenazone
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-

Primary Outcome(s)

Primary end point(s): The primary endpoint is the AUC of the pain intensity measured on a 100 mm visual analogue scale within the time period from 1-5 hours after drug application. The AUC will be calculated using the trapezoidal rule and will be standardized by observation time (i.e. will be divided by 4 hours) in order to keep it compatible to the original VAS scale.

Main Objective: The primary objective is to demonstrate the superiority of the combination therapy of propyphenazone and codeine compared to propyphenazone monotherapy with respect to the primary endpoint, the AUC of the pain intensity measured on a 100 mm visual analogue scale within the time period from 1-5 hours after drug application. The pain intensity will be measured every hour within the first 5 hours after drug application.

Secondary Objective: ? Amount of rescue medication used in the two treatment groups.
? Safety and tolerability of the combination therapy propyphenazone (1000 mg) and codeine (80 mg) compared to the monotherapy of propyphenazone (1000 mg).
? Global satisfaction with the analgesic treatment by using a patient questionnaire within the two treatment groups.

Secondary ID(s)

CSPI135ZDE04