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Lactose IntolerancePhase 3LAILAIINCT01145586

A Non-inferiority, Multicenter and Randomized, Multiple-Dose Study About a Treatment to Hypolactasia

A Phase 3 study testing Lactase Oral Tablets in people with Lactose Intolerance, run by Eurofarma Laboratorios S.A. at 8 sites in Brazil.

Completed

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

Official record
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Trial summary

The primary objective is to determine the compared clinical efficacy of Lactase Eurofarma (test drug), showing non-inferiority to Lactaid® (comparative drug) in the supportive treatment of lactose intolerance and to assess the safety and tolerance of Lactase Eurofarma (test drug) in the supportive treatment of lactose… Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Lactose Intolerance
What is being tested?
Lactase Oral Tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
8 sitesBrazil
Study dates
Jun 2011to May 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

  • To have participated in the single-dose clinical study (EF099) previously performed, with the clinical response being considered as satisfactory by the investigator
  • 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

8 sites in 1 country.

8 sites in 1 country

Brazil8 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 Israelita Albert Einstein

    São Paulo, 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, Blind, Parallel-Group, Multicentre, Multiple-Dose, Comparative Clinical Study of Lactase Eurofarma and Lactaid®, Assessing the Efficacy and Safety in the Treatment of Patients With Lactose Intolerance"

The primary objective is to determine the compared clinical efficacy of Lactase Eurofarma (test drug), showing non-inferiority to Lactaid® (comparative drug) in the supportive treatment of lactose intolerance and to assess the safety and tolerance of Lactase Eurofarma (test drug) in the supportive treatment of lactose intolerance.

Being tested
Lactase Oral Tablets
Medical subject headings
Lactose Intolerance

What participants receive

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

  • Lactase Oral TabletsDrug

    3 tablets/day for 42 days Take with breakfast, lunch and dinner

Study groups in NCT01145586
Study groupRoleWhat they receive
Lactase EUFExperimental1 oral tablet of the test drug before breakfast, lunch and dinner for 42 consecutive days
Receives: Drug: Lactase Oral Tablets
Lactase RefActive comparator1 oral tablet of the comparative drug before breakfast, lunch and dinner for 42 consecutive days
Receives: Drug: Lactase Oral Tablets

What is being measured

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

  1. Hydrogen value in the expired air

    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

Secondary outcomes (1)

  1. Signs and Symptoms Diary

    • Signs and Symptoms Diary, registered for the period between V0 and V1 / V1 and V2;
    • The Specific Symptom Score registered during the tests of hydrogen in the expired air;
    • Global Evaluation of the Treatment Tolerance by the patient and the investigator; Frequency of adverse events noted.

    Measured: 42 days

Timeline

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

  1. First posted16 Jun 2010 (estimated)
  2. Study startJun 2011
  3. Primary completionMar 2012
  4. Study completionMay 2012

Resources

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
NCT01145586
Sponsor's protocol ID
EF099-2
Acronym
LAILAII
Status last verified
Jun 2010
First submitted
15 Jun 2010
Last updated
28 Jun 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • Francesconi CF, Machado MB, Steinwurz F, Nones RB, Quilici FA, Catapani WR, Miszputen SJ, Bafutto M. ORAL ADMINISTRATION OF EXOGENOUS LACTASE IN TABLETS FOR PATIENTS DIAGNOSED WITH LACTOSE INTOLERANCE DUE TO PRIMARY HYPOLACTASIA. Arq Gastroenterol. 2016 Oct-Dec;53(4):228-234. doi: 10.1590/S0004-28032016000400004.

    PubMed 27706451

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lactase Oral Tablets in people with Lactose Intolerance, run by Eurofarma Laboratorios S.A. at 8 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 6 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 28 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 8 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 expired air (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 NCT01145586, which also lists 1 linked publication.

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 28 Jun 2012; AzTrials last refreshed its copy on 28 Oct 2026.

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