Drotaverine in Dysmenorrhoea Treatment
This study has been terminated.
(early termination due to loss of interest and low enrollment of patient)
Information provided by:
First received: February 15, 2006
Last updated: November 14, 2008
Last verified: November 2008
The aim of the study is to show that the combination of drotaverine 80mg and ibuprofen 400 mg is more effective and as well-tolerated as ibuprofen 400 mg or drotaverine 80 mg administered alone, in the treatment of primary and secondary dysmenorrhoea.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
||Comparison of the Efficacy and Tolerability of Drotaverine 80 mg, Ibuprofen 400 mg and Their Combination in a Calendar Packaging for the Treatment of Primary and Secondary Dysmenorrhoea
Primary Outcome Measures:
- Reponse rate in each treatment arm: proportion of patients having pain intensity score 0 or 1 at hour 2 after the first drug intake.
| Estimated Enrollment:
| Study Start Date:
|Ages Eligible for Study:
||18 Years to 45 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- History of at least 6 months of dysmenorrhea, with presence of moderate to severe pain in each of the last 3 cycles
- With regular menstrual cycles (25-35 days)
- Using an adequate barrier contraception method (except for virgins)
- Evidence of clinically relevant gynecological, cardiovascular, hematologic, hepatic, gastrointestinal, renal, pulmonary, endocrinologic, neurologic or psychiatric disease, based on a clinical assessment and routine laboratory investigations
- 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
- Participation in another clinical trial in the last 3 months prior to the start of this study
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00292747
|Budapest, Hungary |
||László Erős, MD
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 15, 2006
||November 14, 2008
||Hungary: National Institute of Pharmacy
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on November 25, 2014
Signs and Symptoms
Central Nervous System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents