HypolactasiaPhase 3EF099NCT01145339

A Non-inferiority, Multicenter and Randomized, Single-Dose Study About a Treatment to Hypolactasia (LAILAI)

A Phase 3 study testing Lactase in people with Hypolactasia, run by Eurofarma Laboratorios S.A. at 7 sites in Brazil.

Completed

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

Trial summary

The study primary objective is to compare the clinical efficacy of two formulations in the supportive treatment of lactose intolerance. Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Hypolactasia
What is being tested?: Lactase
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 140 participants
Where: 7 sitesBrazil
Study dates: Jul 2011to Mar 2012
Phase: Phase 3
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 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

The patient should be a male or female, aged between 18 and 60 years old;
Have a medical history consistent with lactose intolerance, confirmed by the test of hydrogen in the expired air;
The female patients should agree to use birth control methods during the study participation;
To be able to meet the study instructions and all the visits required;
To give a free consent to participate in the study and sign the informed consent form (ICF).

Who cannot join

Smoking;
Secondary hypolactasia;
Gastrointestinal inflammatories diseases - present diverticular disease, diabetic gastropathy or neoplasias;
Colonoscopy or colon cleaning procedure 4 weeks before the start of study
Latrogenic: unnoticed intake of laxatives in over-the-counter drugs or alternative medicine, intake of cereal bran or probiotics;
Diagnosis of HIV, immunodepression of any origin, or cancer under treatment.

Show all 13Show fewer

Diagnosis of other comorbidity that, at the investigator's discretion, may compromise the study participation (e.g., systemic infection during the study or use of antibiotics in the last 4 weeks, diabetes mellitus, uncontrolled hypertension or renal failure),
Hypersensitivity or previous laboratory or clinical adverse event related to the use of lactase or any of the components of the formulations used in the study;
Incapacity to understand and complete the study questionnaires, including the questions that require the use of the Visual Analogue Scale and ICF;
Pregnancy or lactation;
Use of alcohol, exceeding 3 doses daily;
Participation in another clinical study on the last 12 months;
Patient having some chronic pulmonary disease that, in the investigator's opinion, may harm or interfere with the expired hydrogen test (e.g., cystic fibrosis).

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

Brazil7 sites

Instituto Alfa de Gastroenterologia
Belo Horizonte, Minas Gerais
Hospital Nossa Senhora das Graças
Curitiba, Paraná
Instituto Goiano de Gastroenterologia
Goiânia, Goiás
Hospital São Lucas
Porto Alegre, Rio Grande do Sul, 90610-000
Hospital Mãe de Deus
Porto Alegre, Rio Grande do Sul
Faculdade de Medicina do ABC
Santo André, São Paulo
Hospital São Paulo / UNIFESP
São Paulo, São Paulo

Other trials in Brazil

About this study

Official title: A Phase III, Non-Inferiority, Randomized, Double-Blind, Parallel-Group, Multicentre, Single-Dose, Comparative Clinical Study of Lactase Eurofarma (Test Drug) and Lactaid® (Comparative Drug), Assessing the Efficacy and Safety in the Treatment of Patients With Lactose Intolerance (Hypolactasia)

The study primary objective is to compare the clinical efficacy of two formulations in the supportive treatment of lactose intolerance.

Conditions: Hypolactasia
Being tested: Lactase
Medical subject headings: Lactose Intolerance

What participants receive

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

LactaseDrug
1 chewable tablet of the test drug or comparative drug 30 minutes before the standard lactose dose (25 g).

Study groups in NCT01145339
Study group	Role	What they receive
Lactase EUF	Experimental	1 chewable tablet of the test drug 30 minutes before the standard lactose dose (25 g). Receives: Drug: Lactase
Lactase Ref	Active comparator	1 chewable tablet of the comparative drug 30 minutes before the standard lactose dose (25 g). Receives: Drug: Lactase

What is being measured

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

Hydrogen value in the air expired
Hydrogen value in the expired air for 3h after the patient exposure to the standardized Lactose 25g dose with interventional exogenous Lactase (comparative and test drugs).
Measured: 03 times

Timeline

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

Jul 2011Mar 2012

First posted16 Jun 2010 (estimated)
Study startJul 2011
Primary completionNov 2011
Study completionMar 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HypolactasiaStudies of the same condition, open and under way.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 140 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01145339
Sponsor's protocol ID: EF099
Acronym: EF099
Status last verified: Oct 2011
First submitted: 15 Jun 2010
Last updated: 26 Jun 2012
Results posted: No
Data monitoring committee: Yes

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
Partially Hydrolysed Whey Based Formula in Differentiation Between Non IgE Gastrointestinal Cow's Milk Protein Allergy and Milk Intolerance
Cow Milk Protein Allergy, Cow Milk Intolerance
Recruiting
Milk for Diabetes Prevention
Lactose Intolerance, Lactose Intolerant
Enrolling by invitationObservational study
Lactose Intolerance and Intestinal Permability
Lactose Intolerance, Adult Type, Intestinal Permability
Not yet recruitingObservational study
Screening of Lactose Intolerance Among IBS Patients Diarrhea Dominant
Lactose Intolerance
RecruitingPhase 3
Efficacy of a Low FODMAP Diet in the Absence of Lactose Malabsorption in Moderate to Severe ROME IV IBS.
Irritable Bowel Syndrome

All Hypolactasia trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Non-Inferiority, Randomized, Double-Blind, Parallel-Group, Multicentre, Single-Dose, Comparative Clinical Study of Lactase Eurofarma (Test Drug) and Lactaid® (Comparative Drug), Assessing the Efficacy and Safety in the Treatment of Patients With Lactose Intolerance (Hypolactasia)
ClinicalTrials.gov ID: NCT01145339
Acronym / sponsor ID: EF099 / EF099
Conditions: Hypolactasia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 140 participants (actual)
Lead sponsor: Eurofarma Laboratorios S.A.Industry (pharma, biotech, devices)
Study start: Jul 2011
Primary completion: Nov 2011 (actual)
Study completion: Mar 2012 (actual)
First posted: 16 Jun 2010 (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 study primary objective is to compare the clinical efficacy of two formulations in the supportive treatment of lactose intolerance.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
Lactase EUF	Experimental	Drug: Lactase1 chewable tablet of the test drug 30 minutes before the standard lactose dose (25 g).
Lactase Ref	Active comparator	Drug: Lactase1 chewable tablet of the comparative drug 30 minutes before the standard lactose dose (25 g).

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

The patient should be a male or female, aged between 18 and 60 years old;
Have a medical history consistent with lactose intolerance, confirmed by the test of hydrogen in the expired air;
The female patients should agree to use birth control methods during the study participation;
To be able to meet the study instructions and all the visits required;
To give a free consent to participate in the study and sign the informed consent form (ICF).

Key exclusion criteria (13 listed)

Smoking;
Secondary hypolactasia;
Gastrointestinal inflammatories diseases - present diverticular disease, diabetic gastropathy or neoplasias;
Colonoscopy or colon cleaning procedure 4 weeks before the start of study
Latrogenic: unnoticed intake of laxatives in over-the-counter drugs or alternative medicine, intake of cereal bran or probiotics;

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
Lactase1 chewable tablet of the test drug or comparative drug 30 minutes before the standard lactose dose (25 g).	Drug	Lactase EUF, Lactase Ref

Primary outcome

Hydrogen value in the air expired
Time frame: 03 times
Hydrogen value in the expired air for 3h after the patient exposure to the standardized Lactose 25g dose with interventional exogenous Lactase (comparative and test drugs).

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2012.

Related trials for Hypolactasia

Not yet recruiting
Partially Hydrolysed Whey Based Formula in Differentiation Between Non IgE Gastrointestinal Cow's Milk Protein Allergy and Milk Intolerance
Cow Milk Protein Allergy, Cow Milk Intolerance
Recruiting
Milk for Diabetes Prevention
Lactose Intolerance, Lactose Intolerant
Enrolling by invitationObservational study
Lactose Intolerance and Intestinal Permability
Lactose Intolerance, Adult Type, Intestinal Permability
Not yet recruitingObservational study
Screening of Lactose Intolerance Among IBS Patients Diarrhea Dominant
Lactose Intolerance
RecruitingPhase 3
Efficacy of a Low FODMAP Diet in the Absence of Lactose Malabsorption in Moderate to Severe ROME IV IBS.
Irritable Bowel Syndrome

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.

Aderson Damião, M.D principal investigator

Hospital das Clínicas de São Paulo

Heda Amarante, M.D principal investigator

Hospital Nossa Senhora das Graças

Marta Machado, M.D principal investigator

Hospital São Lucas PUCRS

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lactase in people with Hypolactasia, run by Eurofarma Laboratorios S.A. at 7 sites in Brazil.

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 5 inclusion and 13 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 26 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Brazil. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Hydrogen value in the air expired (time frame: 03 times). 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 NCT01145339.

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 26 Jun 2012.