DysmenorrheaPhase 4NCT00292747
Drotaverine in Dysmenorrhoea Treatment
A Phase 4 study testing Drotaverine and Ibuprofen in people with Dysmenorrhea, run by Sanofi at 1 site in Hungary.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Dysmenorrhea
- What is being tested?
- Drotaverine and Ibuprofen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 480 participants
- Where
- 1 siteHungary
- Study dates
- 25 May 2005to 28 Feb 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Dysmenorrhea
- Being tested
- Drotaverine, Drotaverine Placebo, Ibuprofen, Ibuprofen Placebo
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DrotaverineDrug
Also called Z0124
Drotaverine PlaceboDrug
IbuprofenDrug
Ibuprofen PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| drotaverine + Ibuprofen placebo | Experimental | Drotaverine 80 mg plus ibuprofen placebo orally Receives: Drug: Drotaverine; Drug: Ibuprofen Placebo |
| Drotaverine placebo + ibuprofen | Active comparator | Drotaverine placebo plus ibuprofen 400 mg orally Receives: Drug: Drotaverine Placebo; Drug: Ibuprofen |
| Drotaverine + ibuprofen | Active comparator | Drotaverine 80 mg plus ibuprofen 400 mg orally Receives: Drug: Drotaverine; Drug: Ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reponse rate in each treatment arm: proportion of patients having pain intensity score 0 or 1 at hour 2 after the first drug intake.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2006 (estimated)
- Study start25 May 2005
- Primary completion28 Feb 2006
- Study completion28 Feb 2006
Why it stopped: early termination due to loss of interest and low enrollment of patient
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysmenorrheaStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 480 participants
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- László Erős, MD, Study director, Sanofi-aventis, Hungary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00292747
- Sponsor's protocol ID
- L_9134
- Status last verified
- Aug 2017
- First submitted
- 15 Feb 2006
- Last updated
- 8 Aug 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00292747
- Acronym / sponsor ID
- L_9134
- Conditions
- Dysmenorrhea
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: early termination due to loss of interest and low enrollment of patient
- Enrolment
- 480 participants
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 25 May 2005 (actual)
- Primary completion
- 28 Feb 2006 (actual)
- Study completion
- 28 Feb 2006 (actual)
- First posted
- 16 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| drotaverine + Ibuprofen placebo | Experimental | Drug: Drotaverine, Drug: Ibuprofen PlaceboDrotaverine 80 mg plus ibuprofen placebo orally |
| Drotaverine placebo + ibuprofen | Active comparator | Drug: Drotaverine Placebo, Drug: IbuprofenDrotaverine placebo plus ibuprofen 400 mg orally |
| Drotaverine + ibuprofen | Active comparator | Drug: Drotaverine, Drug: IbuprofenDrotaverine 80 mg plus ibuprofen 400 mg orally |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DrotaverineAlso: Z0124 | Drug | Drotaverine + ibuprofen, drotaverine + Ibuprofen placebo |
| Drotaverine Placebo | Drug | Drotaverine placebo + ibuprofen |
| Ibuprofen | Drug | Drotaverine + ibuprofen, Drotaverine placebo + ibuprofen |
| Ibuprofen Placebo | Drug | drotaverine + Ibuprofen placebo |
Primary outcome
Reponse rate in each treatment arm: proportion of patients having pain intensity score 0 or 1 at hour 2 after the first drug intake.
Results and safety
The study was stopped early (reason given: early termination due to loss of interest and low enrollment of patient). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
László Erős, MD study director
Sanofi-aventis, Hungary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Drotaverine and Ibuprofen in people with Dysmenorrhea, run by Sanofi at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: early termination due to loss of interest and low enrollment of patient). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2017.