Observational Prospective Study to Evaluate AEs, Risk Factors and Drug Utilization of BUSCAPINA COMPOSITUM N in Adults From Metropolitan Lima

An observational study of Acute Pain and Dysmenorrhea, run by Boehringer Ingelheim at 1 site in Peru.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

What AE occur in routine clinical practice, what is the incidence of AE and Adverse Drug Reaction, how many patients present with AE symptoms related to a potential liver injury. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Acute Pain, Dysmenorrhea
What is being tested?: Hyoscine n-butylbromide and Paracetamol
How many people: 360 participants
Where: 1 sitePeru
Study dates: 15 Oct 2016to 20 Feb 2017
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Metropolitan Lima

Who may be able to join

Patients 18 years of age and older who have received at least one dose of BUSCAPINA COMPOSITUM N according to label indications and who attend to one of the pharmacies, clinics, or private doctors office selected for the study.
Patients who agree to adhere to the protocol procedures of this study.
Women who are not pregnant or breast feeding
Persons who sign the informed consent

Who cannot join

Patients with allergy to BUSCAPINA COMPOSITUM N or any of the compounds in the formula.
Patients with mechanical stenosis of the gastrointestinal tract.
Patients with myasthenia gravis.
Patients with megacolon.
Patients breastfeeding at the time of enrollment or who have become pregnant during treatment with BUSCAPINA COMPOSITUM N.
Patients with clinical evidence of immunosuppression.

Show all 14Show fewer

Patients with urinary retention subvesical obstruction (such as prostatic adenoma).
Patients with right-angle glaucoma.
Patients with tachycardia and tachyarrhythmia.
Patients with severe hepatic impairment.
Patients with psychiatric disorders.
Patients with alcohol dependence or drugs.
Patients who discontinue the protocol are not eligible for re-enrollment.
Researchers, company personnel or their relatives.

Trial locations and contacts

1 site in 1 country.

Peru1 site

Study site
Multiple Locations

Other trials in Peru

About this study

Official title: Observational Prospective Cohort Study to Evaluate the Incidence of Adverse Events (AE), Risk Factors, and Drug Utilization Patterns Related to Treatment With BUSCAPINA COMPOSITUM N From March to December 2016 in Patients From Metropolitan Lima

What AE occur in routine clinical practice, what is the incidence of AE and Adverse Drug Reaction, how many patients present with AE symptoms related to a potential liver injury. What are the drug utilization patterns in patients, what are the predisposing factors for the occurrence of adverse events and adverse drug reactions.

Conditions: Acute Pain, Dysmenorrhea
Being tested: Hyoscine n-butylbromide, Paracetamol
Medical subject headings: Acute Pain, Dysmenorrhea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Hyoscine n-butylbromideDrug
Hyoscine n-butylbromide 10 mg
ParacetamolDrug
Paracetamol 500 mg
Hyoscine n-butylbromideDrug
Hyoscine n-butylbromide 10 mg
ParacetamolDrug
Paracetamol 500 mg

Study groups in NCT02910167
Study group	Role	What they receive
Men with spasmodic syndromes		Men with any type of gastrointestinal, hepato-biliary, urinary or genital spasmodic syndromes Receives: Drug: Hyoscine n-butylbromide; Drug: Paracetamol
Women with spasmodic syndromes		Women with any type of gastrointestinal, hepato-biliary, urinary or genital spasmodic syndromes Receives: Drug: Hyoscine n-butylbromide; Drug: Paracetamol

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Patients With an Incidence of Adverse Event (AE) Associated to Potential Liver Damage During the Clinical Evaluation of Patients
Percentage of patients with an incidence of Adverse Event (AE) associated to potential liver damage during the clinical evaluation of patients.
Measured: From the initial dose of study drug until end of the follow up period, up to 113 days

Secondary outcomes (4)

Percentage of Patients With Different Transaminase Levels Found by the Doctor During the Clinical Evaluation of Patients With Symptoms Related to Potential Liver Damage.
Percentage of patients with different transaminase levels found by the doctor during the clinical evaluation of patients with symptoms related to potential liver damage. No patient with symptoms related to potential liver damage was identified, thus analyses of transaminase levels was not performed.
Measured: From the initial dose of study drug until end of the follow up period, up to 113 days
Percentage of Patients With Different Drug Utilization Patterns of Buscapina Compositum N in Patients in Metropolitan Lima
Percentage of patients with different drug utilization patterns of Buscapina Compositum N in patients in Metropolitan Lima.
Measured: From the initial dose of study drug until end of the follow up period, up to 113 days
Percentage of Patients Per Adverse Event Preferred Term in Patients Who Developed Any Adverse Event During Treatment
Percentage of patients per adverse event preferred term in patients who developed any adverse event during treatment with Buscapina Compositum N.
Measured: From the initial dose of study drug until end of the follow up period, up to 113 days
Percentage of Patients With Different Variables Related to the Occurrence of Increase of Transaminases in Patients Under Treatment With Buscapina Compositum N
Percentage of patients with different variables related to the occurrence of increase of transaminases in patients under treatment with Buscapina Compositum N in Metropolitan Lima. No patient with symptoms related to potential liver damage was identified, thus analyses of transaminase levels was not performed.
Measured: From the initial dose of study drug until end of the follow up period, up to 113 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Oct 201620 Feb 2017

First posted21 Sep 2016 (estimated)
Study start15 Oct 2016
Primary completion20 Feb 2017
Study completion20 Feb 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Acute PainStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 360 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02910167
Sponsor's protocol ID: 218.705
Status last verified: Mar 2019
First submitted: 30 Aug 2016
Last updated: 27 Mar 2019
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruitingPhase 2
A Clinical Trial of MK-6916 in Participants With Pain After Bunion Removal Surgery (MK-6916-007)
Pain Management
Not yet recruitingPhase 2
Investigating the Analgesic Potential of (2R,6R)-HNK in Acute Pain in Healthy Volunteers
Healthy Volunteers
Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)

All Acute Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Observational Prospective Cohort Study to Evaluate the Incidence of Adverse Events (AE), Risk Factors, and Drug Utilization Patterns Related to Treatment With BUSCAPINA COMPOSITUM N From March to December 2016 in Patients From Metropolitan Lima
ClinicalTrials.gov ID: NCT02910167
Acronym / sponsor ID: 218.705
Conditions: Acute Pain, Dysmenorrhea
Study type: Observational
Recruitment status: Completed
Enrolment: 360 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 15 Oct 2016 (actual)
Primary completion: 20 Feb 2017 (actual)
Study completion: 20 Feb 2017 (actual)
First posted: 21 Sep 2016 (estimated)
Results: Posted 27 Mar 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Men with spasmodic syndromes	–	Drug: Hyoscine n-butylbromide, Drug: ParacetamolMen with any type of gastrointestinal, hepato-biliary, urinary or genital spasmodic syndromes
Women with spasmodic syndromes	–	Drug: Hyoscine n-butylbromide, Drug: ParacetamolWomen with any type of gastrointestinal, hepato-biliary, urinary or genital spasmodic syndromes

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Metropolitan Lima

Key inclusion criteria (4 listed)

Patients 18 years of age and older who have received at least one dose of BUSCAPINA COMPOSITUM N according to label indications and who attend to one of the pharmacies, clinics, or private doctors office selected for the study.
Patients who agree to adhere to the protocol procedures of this study.
Women who are not pregnant or breast feeding
Persons who sign the informed consent

Key exclusion criteria (14 listed)

Patients with allergy to BUSCAPINA COMPOSITUM N or any of the compounds in the formula.
Patients with mechanical stenosis of the gastrointestinal tract.
Patients with myasthenia gravis.
Patients with megacolon.
Patients breastfeeding at the time of enrollment or who have become pregnant during treatment with BUSCAPINA COMPOSITUM N.

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
Hyoscine n-butylbromideHyoscine n-butylbromide 10 mg	Drug	Men with spasmodic syndromes
ParacetamolParacetamol 500 mg	Drug	Men with spasmodic syndromes
Hyoscine n-butylbromideHyoscine n-butylbromide 10 mg	Drug	Women with spasmodic syndromes
ParacetamolParacetamol 500 mg	Drug	Women with spasmodic syndromes

Primary outcome

Percentage of Patients With an Incidence of Adverse Event (AE) Associated to Potential Liver Damage During the Clinical Evaluation of Patients
Time frame: From the initial dose of study drug until end of the follow up period, up to 113 days
Percentage of patients with an incidence of Adverse Event (AE) associated to potential liver damage during the clinical evaluation of patients.

4 secondary outcomes

Percentage of Patients With Different Transaminase Levels Found by the Doctor During the Clinical Evaluation of Patients With Symptoms Related to Potential Liver Damage.
Time frame: From the initial dose of study drug until end of the follow up period, up to 113 days
Percentage of Patients With Different Drug Utilization Patterns of Buscapina Compositum N in Patients in Metropolitan Lima
Time frame: From the initial dose of study drug until end of the follow up period, up to 113 days
Percentage of Patients Per Adverse Event Preferred Term in Patients Who Developed Any Adverse Event During Treatment
Time frame: From the initial dose of study drug until end of the follow up period, up to 113 days
Percentage of Patients With Different Variables Related to the Occurrence of Increase of Transaminases in Patients Under Treatment With Buscapina Compositum N
Time frame: From the initial dose of study drug until end of the follow up period, up to 113 days

Results and safety

Results posted to the registry on 27 Mar 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Buscapina Compositum N	360	341

Primary outcome: Percentage of Patients With an Incidence of Adverse Event (AE) Associated to Potential Liver Damage During the Clinical Evaluation of Patients

Time frame: From the initial dose of study drug until end of the follow up period, up to 113 days. Number. Unit: Percentage of Patients

Measure	Buscapina Compositum N n = 342
Value	0.0

Population analysed: Patients who have received at least one dose of Buscapina Compositum N according to label indications, attended to one of the health centers selected for the study, and who provided data for the baseline and the follow-up visit.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the initial dose of study drug until end of the follow up period, up to 113 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Buscapina Compositum N	0 of 360 (0%)	0 of 360 (0%)	0 of 360

Limitations and caveats (from the sponsor): Since the study is conducted at some health centers, it cannot be generalized to the whole population who uses study drug. It is without a control group, thus not able to compare cumulative incidence of AE with the patients not exposed to this drug

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Acute Pain

Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruitingPhase 2
A Clinical Trial of MK-6916 in Participants With Pain After Bunion Removal Surgery (MK-6916-007)
Pain Management
Not yet recruitingPhase 2
Investigating the Analgesic Potential of (2R,6R)-HNK in Acute Pain in Healthy Volunteers
Healthy Volunteers
Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)

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.

Boehringer Ingelheim study chair

Boehringer Ingelheim

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Pain and Dysmenorrhea, run by Boehringer Ingelheim at 1 site in Peru.

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 4 inclusion and 14 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: finished, as of the sponsor's last update on 27 Mar 2019. 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 Peru. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Patients With an Incidence of Adverse Event (AE) Associated to Potential Liver Damage During the Clinical Evaluation of Patients (time frame: From the initial dose of study drug until end of the follow up period, up to 113 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02910167.

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 27 Mar 2019.