Acute Pain, Dysmenorrhea
Conditions
Brief 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. What are the drug utilization patterns in patients, what are the predisposing factors for the occurrence of adverse events and adverse drug reactions.
Interventions
DRUGHyoscine n-butylbromide
Hyoscine n-butylbromide 10 mg
DRUGParacetamol
Paracetamol 500 mg
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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. 2. Patients who agree to adhere to the protocol procedures of this study. 3. Women who are not pregnant or breast feeding 4. Persons who sign the informed consent
Exclusion criteria
1. Patients with allergy to BUSCAPINA COMPOSITUM N or any of the compounds in the formula. 2. Patients with mechanical stenosis of the gastrointestinal tract. 3. Patients with myasthenia gravis. 4. Patients with megacolon. 5. Patients breastfeeding at the time of enrollment or who have become pregnant during treatment with BUSCAPINA COMPOSITUM N. 6. Patients with clinical evidence of immunosuppression. 7. Patients with urinary retention subvesical obstruction (such as prostatic adenoma). 8. Patients with right-angle glaucoma. 9. Patients with tachycardia and tachyarrhythmia. 10. Patients with severe hepatic impairment. 11. Patients with psychiatric disorders. 12. Patients with alcohol dependence or drugs. 13. Patients who discontinue the protocol are not eligible for re-enrollment. 14. Researchers, company personnel or their relatives.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With an Incidence of Adverse Event (AE) Associated to Potential Liver Damage During the Clinical Evaluation of Patients | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Different Transaminase Levels Found by the Doctor During the Clinical Evaluation of Patients With Symptoms Related to Potential Liver Damage. | From the initial dose of study drug until end of the follow up period, up to 113 days | 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. |
| Percentage of Patients With Different Drug Utilization Patterns of Buscapina Compositum N in Patients in Metropolitan Lima | 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 Per Adverse Event Preferred Term in Patients Who Developed Any Adverse Event During Treatment | 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 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 | 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 in Metropolitan Lima. No patient with symptoms related to potential liver damage was identified, thus analyses of transaminase levels was not performed. |
Countries
Peru
Participant flow
Recruitment details
Observational prospective study to evaluate adverse events (AEs), Risk factors and drug utilization of Buscapina Compositum N in adults from metropolitan lima
Pre-assignment details
All patients were screened for eligibility to participate in the trial. Patients attended one of 4 specialist sites which ensured that they met all strictly implemented inclusion/exclusion criteria. Patients were not to be entered to trial treatment if any one of the specific entry criteria was violated.
Participants by arm
| Arm | Count |
|---|---|
| Buscapina Compositum N Combination of 10 milligram (mg) of hyoscine n-butylbromide (HBB) and 500 mg of paracetamol. The dose of Buscapina Compositum N was according to label instructions which patients had to acquire on their own (one to two tablets by mouth every 8 hours for 3 to 4 days, swallowed whole with sufficient water). | 360 |
| Total | 360 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Lost to Follow-up | 18 |
Baseline characteristics
| Characteristic | Buscapina Compositum N | — |
|---|---|---|
| Age, Continuous | 36.2 Years STANDARD_DEVIATION 13.6 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 270 Participants | — |
| Sex: Female, Male Male | 90 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 360 |
| other Total, other adverse events | 0 / 360 |
| serious Total, serious adverse events | 0 / 360 |
Outcome results
Primary
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.
Time frame: From the initial dose of study drug until end of the follow up period, up to 113 days
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Buscapina Compositum N | Percentage of Patients With an Incidence of Adverse Event (AE) Associated to Potential Liver Damage During the Clinical Evaluation of Patients | 0.0 Percentage of Patients |
Secondary
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.
Time frame: From the initial dose of study drug until end of the follow up period, up to 113 days
Population: 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, provided data for the baseline and the follow-up visit, and who developed any adverse event during treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Buscapina Compositum N | Percentage of Patients Per Adverse Event Preferred Term in Patients Who Developed Any Adverse Event During Treatment | Abdominal pain (upper) | 0.3 Percentage of Patients |
| Buscapina Compositum N | Percentage of Patients Per Adverse Event Preferred Term in Patients Who Developed Any Adverse Event During Treatment | Diarrhoea | 0.3 Percentage of Patients |
| Buscapina Compositum N | Percentage of Patients Per Adverse Event Preferred Term in Patients Who Developed Any Adverse Event During Treatment | Nausea | 0.3 Percentage of Patients |
| Buscapina Compositum N | Percentage of Patients Per Adverse Event Preferred Term in Patients Who Developed Any Adverse Event During Treatment | Constipation | 0.3 Percentage of Patients |
| Buscapina Compositum N | Percentage of Patients Per Adverse Event Preferred Term in Patients Who Developed Any Adverse Event During Treatment | Abdominal Pain | 0.3 Percentage of Patients |
| Buscapina Compositum N | Percentage of Patients Per Adverse Event Preferred Term in Patients Who Developed Any Adverse Event During Treatment | Dizziness | 0.3 Percentage of Patients |
| Buscapina Compositum N | Percentage of Patients Per Adverse Event Preferred Term in Patients Who Developed Any Adverse Event During Treatment | Somnolence | 1.2 Percentage of Patients |
| Buscapina Compositum N | Percentage of Patients Per Adverse Event Preferred Term in Patients Who Developed Any Adverse Event During Treatment | Cough | 0.3 Percentage of Patients |
| Buscapina Compositum N | Percentage of Patients Per Adverse Event Preferred Term in Patients Who Developed Any Adverse Event During Treatment | Urine color abnormal | 0.3 Percentage of Patients |
| Buscapina Compositum N | Percentage of Patients Per Adverse Event Preferred Term in Patients Who Developed Any Adverse Event During Treatment | Headache + nausea | 0.3 Percentage of Patients |
| Buscapina Compositum N | Percentage of Patients Per Adverse Event Preferred Term in Patients Who Developed Any Adverse Event During Treatment | Nausea + constipation | 0.3 Percentage of Patients |
| Buscapina Compositum N | Percentage of Patients Per Adverse Event Preferred Term in Patients Who Developed Any Adverse Event During Treatment | Flatulence + constipation | 0.3 Percentage of Patients |
| Buscapina Compositum N | Percentage of Patients Per Adverse Event Preferred Term in Patients Who Developed Any Adverse Event During Treatment | Polydipsia + abdominal pain (upper) | 0.3 Percentage of Patients |
Secondary
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.
Time frame: From the initial dose of study drug until end of the follow up period, up to 113 days
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Buscapina Compositum N | Percentage of Patients With Different Drug Utilization Patterns of Buscapina Compositum N in Patients in Metropolitan Lima | Patient took the medication with liquids (Yes) | 100.0 Percentage of Patients |
| Buscapina Compositum N | Percentage of Patients With Different Drug Utilization Patterns of Buscapina Compositum N in Patients in Metropolitan Lima | Patient took the medication with liquids (No) | 0.0 Percentage of Patients |
| Buscapina Compositum N | Percentage of Patients With Different Drug Utilization Patterns of Buscapina Compositum N in Patients in Metropolitan Lima | Type of liquid used (Water) | 94.7 Percentage of Patients |
| Buscapina Compositum N | Percentage of Patients With Different Drug Utilization Patterns of Buscapina Compositum N in Patients in Metropolitan Lima | Type of liquid used (Juice) | 8 Percentage of Patients |
| Buscapina Compositum N | Percentage of Patients With Different Drug Utilization Patterns of Buscapina Compositum N in Patients in Metropolitan Lima | Type of liquid used (Other) | 2.9 Percentage of Patients |
| Buscapina Compositum N | Percentage of Patients With Different Drug Utilization Patterns of Buscapina Compositum N in Patients in Metropolitan Lima | Amount of liquid used (A straw/sip) | 0.3 Percentage of Patients |
| Buscapina Compositum N | Percentage of Patients With Different Drug Utilization Patterns of Buscapina Compositum N in Patients in Metropolitan Lima | Amount of liquid used (1/4 cup) | 3.8 Percentage of Patients |
| Buscapina Compositum N | Percentage of Patients With Different Drug Utilization Patterns of Buscapina Compositum N in Patients in Metropolitan Lima | Amount of liquid used (1/2 cup) | 33.0 Percentage of Patients |
| Buscapina Compositum N | Percentage of Patients With Different Drug Utilization Patterns of Buscapina Compositum N in Patients in Metropolitan Lima | Amount of liquid used (A full cup) | 44.7 Percentage of Patients |
| Buscapina Compositum N | Percentage of Patients With Different Drug Utilization Patterns of Buscapina Compositum N in Patients in Metropolitan Lima | Amount of liquid used (More than a cup) | 18.1 Percentage of Patients |
| Buscapina Compositum N | Percentage of Patients With Different Drug Utilization Patterns of Buscapina Compositum N in Patients in Metropolitan Lima | Storage of medicine (In a dry and fresh location) | 98.0 Percentage of Patients |
| Buscapina Compositum N | Percentage of Patients With Different Drug Utilization Patterns of Buscapina Compositum N in Patients in Metropolitan Lima | Storage of medicine (In a hot location) | 0.3 Percentage of Patients |
| Buscapina Compositum N | Percentage of Patients With Different Drug Utilization Patterns of Buscapina Compositum N in Patients in Metropolitan Lima | Storage of medicine (In the refrigerator) | 0.0 Percentage of Patients |
| Buscapina Compositum N | Percentage of Patients With Different Drug Utilization Patterns of Buscapina Compositum N in Patients in Metropolitan Lima | Storage of medicine (Other) | 1.8 Percentage of Patients |
| Buscapina Compositum N | Percentage of Patients With Different Drug Utilization Patterns of Buscapina Compositum N in Patients in Metropolitan Lima | Reason - Not taking medicine (No symptoms anymore) | 51.4 Percentage of Patients |
| Buscapina Compositum N | Percentage of Patients With Different Drug Utilization Patterns of Buscapina Compositum N in Patients in Metropolitan Lima | Reason - Not taking medicine (Forgot it) | 23.4 Percentage of Patients |
| Buscapina Compositum N | Percentage of Patients With Different Drug Utilization Patterns of Buscapina Compositum N in Patients in Metropolitan Lima | Reason - Not taking medicine (Had no time) | 5.6 Percentage of Patients |
| Buscapina Compositum N | Percentage of Patients With Different Drug Utilization Patterns of Buscapina Compositum N in Patients in Metropolitan Lima | Reason - Not taking medicine (Other) | 12.2 Percentage of Patients |
| Buscapina Compositum N | Percentage of Patients With Different Drug Utilization Patterns of Buscapina Compositum N in Patients in Metropolitan Lima | Reason - Not taking medicine (No answer) | 7.5 Percentage of Patients |
Secondary
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.
Time frame: From the initial dose of study drug until end of the follow up period, up to 113 days
Population: 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, provided data for the baseline and the follow-up visit, and who reported symptoms related to potential liver damage at the follow-up visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Buscapina Compositum N | Percentage of Patients With Different Transaminase Levels Found by the Doctor During the Clinical Evaluation of Patients With Symptoms Related to Potential Liver Damage. | NA Percentage of Patients |
Secondary
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.
Time frame: From the initial dose of study drug until end of the follow up period, up to 113 days
Population: 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, provided data for the baseline and the follow-up visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 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 | NA Percentage of Patients |