Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
480 participants
INTERVENTIONAL
2005-05-25
2006-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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drotaverine + Ibuprofen placebo
Drotaverine 80 mg plus ibuprofen placebo orally
Drotaverine
Ibuprofen Placebo
Drotaverine placebo + ibuprofen
Drotaverine placebo plus ibuprofen 400 mg orally
Drotaverine Placebo
Ibuprofen
Drotaverine + ibuprofen
Drotaverine 80 mg plus ibuprofen 400 mg orally
Drotaverine
Ibuprofen
Interventions
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Drotaverine
Drotaverine Placebo
Ibuprofen
Ibuprofen Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* With regular menstrual cycles (25-35 days)
* Using an adequate barrier contraception method (except for virgins)
Exclusion Criteria
* Proven hypersensitivity to drotaverine hydrochloride or ibuprofen or proven intolerance to lactose
* Any described contraindication to either drotaverine hydrochloride or ibuprofen (see Summary of Product Characteristics)
* Oestro-progestative contraception within the last 2 months
* Regular use of sedative, hypnotics, tranquillizers or any other addictive agents
* History or evidence of acute or chronic alcohol abuse
* Heavy smoking (\> 10 cigarettes/day)
* Need of a permanent treatment with other antispasmodics and/or analgesic agents during the trial
* Lactation
* Pregnancy
* Participation in another clinical trial in the last 3 months prior to the start of this study
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
18 Years
45 Years
FEMALE
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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László Erős, MD
Role: STUDY_DIRECTOR
Sanofi-aventis, Hungary
Locations
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Sanofi-Aventis
Budapest, , Hungary
Countries
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Other Identifiers
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L_9134
Identifier Type: -
Identifier Source: org_study_id
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