search
Back to results

Drotaverine in Dysmenorrhoea Treatment

Primary Purpose

Dysmenorrhea

Status
Terminated
Phase
Phase 4
Locations
Hungary
Study Type
Interventional
Intervention
Drotaverine
Drotaverine Placebo
Ibuprofen
Ibuprofen Placebo
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysmenorrhea

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Sanofi-Aventis

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

drotaverine + Ibuprofen placebo

Drotaverine placebo + ibuprofen

Drotaverine + ibuprofen

Arm Description

Drotaverine 80 mg plus ibuprofen placebo orally

Drotaverine placebo plus ibuprofen 400 mg orally

Drotaverine 80 mg plus ibuprofen 400 mg orally

Outcomes

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.

Secondary Outcome Measures

Full Information

First Posted
February 15, 2006
Last Updated
August 4, 2017
Sponsor
Sanofi
search

1. Study Identification

Unique Protocol Identification Number
NCT00292747
Brief Title
Drotaverine in Dysmenorrhoea Treatment
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Terminated
Why Stopped
early termination due to loss of interest and low enrollment of patient
Study Start Date
May 25, 2005 (Actual)
Primary Completion Date
February 28, 2006 (Actual)
Study Completion Date
February 28, 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysmenorrhea

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
480 (false)

8. Arms, Groups, and Interventions

Arm Title
drotaverine + Ibuprofen placebo
Arm Type
Experimental
Arm Description
Drotaverine 80 mg plus ibuprofen placebo orally
Arm Title
Drotaverine placebo + ibuprofen
Arm Type
Active Comparator
Arm Description
Drotaverine placebo plus ibuprofen 400 mg orally
Arm Title
Drotaverine + ibuprofen
Arm Type
Active Comparator
Arm Description
Drotaverine 80 mg plus ibuprofen 400 mg orally
Intervention Type
Drug
Intervention Name(s)
Drotaverine
Other Intervention Name(s)
Z0124
Intervention Type
Drug
Intervention Name(s)
Drotaverine Placebo
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Intervention Type
Drug
Intervention Name(s)
Ibuprofen Placebo
Primary Outcome Measure Information:
Title
Reponse rate in each treatment arm: proportion of patients having pain intensity score 0 or 1 at hour 2 after the first drug intake.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
László Erős, MD
Organizational Affiliation
Sanofi-aventis, Hungary
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis
City
Budapest
Country
Hungary

12. IPD Sharing Statement

Learn more about this trial

Drotaverine in Dysmenorrhoea Treatment

We'll reach out to this number within 24 hrs