Drotaverine in Dysmenorrhoea Treatment

August 4, 2017 updated by: Sanofi

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

480

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • Budapest, Hungary
        • Sanofi-Aventis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: drotaverine + Ibuprofen placebo
Drotaverine 80 mg plus ibuprofen placebo orally
Drug: Drotaverine
Other Names:
  • Z0124
Drug: Ibuprofen Placebo
Active Comparator: Drotaverine placebo + ibuprofen
Drotaverine placebo plus ibuprofen 400 mg orally
Drug: Ibuprofen
Drug: Drotaverine Placebo
Active Comparator: Drotaverine + ibuprofen
Drotaverine 80 mg plus ibuprofen 400 mg orally
Drug: Ibuprofen
Drug: Drotaverine
Other Names:
  • Z0124

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Reponse rate in each treatment arm: proportion of patients having pain intensity score 0 or 1 at hour 2 after the first drug intake.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Investigators

  • Study Director: László Erős, MD, Sanofi-aventis, Hungary

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 25, 2005

Primary Completion (Actual)

February 28, 2006

Study Completion (Actual)

February 28, 2006

Study Registration Dates

First Submitted

February 15, 2006

First Submitted That Met QC Criteria

February 15, 2006

First Posted (Estimate)

February 16, 2006

Study Record Updates

Last Update Posted (Actual)

August 8, 2017

Last Update Submitted That Met QC Criteria

August 4, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • L_9134

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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