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AcromegalyPhase 4LEADNCT00701363

Study to Assess the Efficacy of an Extended Injection Interval Schedule of Lanreotide Autogel in Acromegalic Subjects

A Phase 4 study testing Lanreotide Autogel 120 mg in people with Acromegaly, run by Ipsen at 44 sites in 14 countries.

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 purpose of the study is to assess the efficacy of an extended injection interval schedule of lanreotide Autogel 120 mg in acromegalic subjects who are biochemically controlled on long term treatment with octreotide LAR 10 or 20 mg Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acromegaly
What is being tested?
Lanreotide Autogel 120 mg
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
124 participants
Where
44 sitesin 14 countries
Study dates
Oct 2008to May 2013
Phase
Phase 4
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

Who may be able to join

  • The subject has given written informed consent prior to any study-related procedures
  • The subject is male or female and is over 18 years of age
  • The subject must have had documentation supporting the diagnosis of acromegaly, based on elevated IGF-1 and/or GH levels
  • The subject has been receiving octreotide LAR (10 or 20 mg) treatment for at least six months and is biochemically controlled. Control is defined as normal (age and sex adjusted) IGF 1 levels for two consecutive measurements (at least two months apart) preceding study entry
  • If the subject is receiving dopamine agonist therapy, treatment should be stable for at least four months, and no change in their dopamine-agonist medication is expected during the entire study period

Who cannot join

  • The subject has received radiation therapy to the pituitary gland before study entry
  • The subject has a history of hypersensitivity to lanreotide or drugs with a similar chemical structure
  • The subject has received a growth hormone receptor antagonist (pegvisomant) therapy within three months before study entry
  • The subject has undergone treatment with any other investigational drug in the 30 days before study entry or is scheduled to receive an investigational drug, other than lanreotide 120 mg, during the course of the study
  • The subject has received any unlicensed drug within the 30 days prior to the baseline visit or is scheduled to receive an unlicensed drug during the course of the study

Trial locations and contacts

44 sites in 14 countries.

44 sites in 14 countries

France15 sites

  • CHU Besançon - Hôpital Jean Minjoz

    Besançon, 25030

  • Hôpital Avicenne - Bâtiment Madeleine Breis

    Bobigny, 93009

  • Hôpital Neurologique - Pierre Wertheimer

    Bron, 69677

  • Hôpital du Bocage Sud - Service d'Endocrinologie

    Dijon, 21079

  • CH La Rochelle - Hopital Saint Louis - Service de Médecine interne - Endocrinologie - Maladies Métaboliques- Nutrition

    La Rochelle, 17019

  • Hôpital Du Cluzeau - Service de Médecine B

    Limoges, 87042

  • Hôpital Archet 1 - Service d'Endocrinologie

    Nice, 06200

  • CHU de Nîmes - Hôpital Caremeau

    Nîmes, 30029

  • Hôpital Lariboisière - Service Médecine Interne - Endocrinologie - Nutrition

    Paris, 75010

  • Hopital Pitié-Salpêtrière - Service d'Endocrinologie

    Paris, 75013

  • Hôpital Cochin - Saint-Vincent-de-Paul - La-Roche-Guyon

    Paris, 75074

  • Hôpital Haut Lévêque - Unité de soins normalisés

    Pessac, 33604

  • Hôpital Robert Debré

    Reims, 51092

  • Hôpital de Hautepierre, Service de Médecine Interne et Nutrition

    Strasbourg, 67098

  • CHU de Tours - Hopital Bretonneau - Service Endocrinologie-Diabétologie Medecine B

    Tours, 37044

Other trials in France

Greece4 sites

  • Evangelismos Hospital - Department of Endocrinology

    Athens

  • Polykliniki Hospital - Department of Endocrinology

    Athens

  • Metaxa Hospital - Department of Endocrinology

    Piraeus

  • B IKA Panagia Hospital - Department of Endocrinology

    Thessaloniki

Other trials in Greece

Denmark3 sites

  • Arhus University Hospital - Department of Medicinsk AVd M

    Arhus C, DK 8000

  • Righospitalet - University Department of Endocrinology & Internal Medicine P

    Copenhagen, DK-2100

  • Odense University Hospital - Department of Endocrinology

    Odense C, DK-5000

Other trials in Denmark

Poland3 sites

  • Swietorkryskie Centrum Onkologii, UL. Artwinskiego 3 - Department of endocrinology and Nuclear Medecine

    Kielce, 25-734

  • University Hospital in Krakow, Dept. of Endocrinology, Kopernika Str. 17

    Krakow, 31501

  • Samodzielny Publiczny Szpital Kliniczny nr 1, Ul. Pasteura 4

    Wroclaw, 50-367

Other trials in Poland

South Korea3 sites

  • Seoul National University hospital, 28 Yongon-dong Chongno-gu

    Seoul, 110-744

  • Yonsei University Severance Hospital - Department of Endocrinology and Metabolism

    Seoul, 120-752

  • Sungkyunkwan University Samsung Medical Center

    Seoul, 135-710

Other trials in South Korea

Sweden3 sites

  • EM-Kliniken, Universitetssjukhuset

    Linköping, 581 85

  • Skane University Hospital, Department of Endocrinology

    Lund, 221 85

  • Karolinska University Hospital, Dpt of Endocrinology, Metabolism & Diabetology, Solna

    Stockholm, 17176

Other trials in Sweden

Brazil2 sites

  • Universidade Federal do Rio de Janeiro - Department of Internal Medicine - Section of Endocrinology - Neuroendocrine Research Center

    Rio de Janeiro

  • Hospital das Clínicas de São Paulo - Internal Medicine - Neuroendocrine Unit - Division of Endocrinology and Metabolism

    São Paulo

Other trials in Brazil

Finland2 sites

  • Helsinki University Central Hospital - (HUCH) Division of Endocrinology - Department of Medicine

    Helsinki, 00290

  • Kuopio University Hospital - Department of Medicine, Internal Medicine/Endocrinology and Diabetology Division

    Kuopio, 70210

Other trials in Finland

Netherlands2 sites

  • Erasmus Medical Centre - Department of Endocrinology

    Rotterdam, NL-3015 CE

  • UMC Utrecht - Department of Endocrinology, Heidelberglaan 100

    Utrecht, NL-3584 CX

Other trials in Netherlands

Russia2 sites

  • Federal State Institution "Endocrinology Research Centre - Federal agency of high-tech medical care" - Neuroendocrinology & Osteopathy Department

    Moscow

  • I.M. Sechenov Moscow Medical Academy - Endocrinology Department

    Moscow

Other trials in Russia

Serbia2 sites

  • Clinical Centre of Serbia - Institute for Endocrinology, Diabetes and Metabolic Diseases, - Dr Subotica Street n°13

    Belgrade, 11000

  • Clinic for Endocrinology, Diabetes and Metabolic Disorders, Clinical Center of Vojvodina, Hajduk Veljkova 3-9

    Novi Sad, 21000

Other trials in Serbia

Latvia1 site

  • P. Stradins Clinical University Hospital - Department of Endocrinology

    Riga, 1002

Other trials in Latvia

Norway1 site

  • Department of Medicine, Haukeland Hospital Jonas Lies

    Bergen, N-5009

Other trials in Norway

Romania1 site

  • University of Medicine and Pharmacy Iuliu Hatieganu

    Cluj-Napoca

Other trials in Romania

About this study

Official title: A Prospective, International, Multi-centric, Open-label Study to Assess the Efficacy of an Extended Injection Interval Schedule of Lanreotide Autogel 120 mg in Acromegalic Subjects Who Are Biochemically Controlled on the Long Term Treatment With Octreotide LAR 10 or 20 mg

The purpose of the study is to assess the efficacy of an extended injection interval schedule of lanreotide Autogel 120 mg in acromegalic subjects who are biochemically controlled on long term treatment with octreotide LAR 10 or 20 mg

Conditions
Acromegaly
Being tested
Lanreotide Autogel 120 mg
Medical subject headings
Acromegaly

What participants receive

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

  • Lanreotide Autogel 120 mgDrug

    120mg, injections every 6 weeks, then depending on IGF-1 results at Week 24

Study groups in NCT00701363
Study groupRoleWhat they receive
Lanreotide Autogel 120 mgExperimentalNot described
Receives: Drug: Lanreotide Autogel 120 mg

What is being measured

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

  1. Percentage of Subjects Having Maintained Their Injection Interval Schedule of Six Weeks or Increased Their Injection Interval to Eight Weeks Whilst Keeping Their Normalised Insulin Growth Factor (IGF-1) Levels (Age and Sex Adjusted)

    A subject was responder if he maintained his injection interval schedule of 6 weeks or increased his injection interval to eight weeks whilst keeping his normalised IGF-1 level (age and sex adjusted) at the end of the study (Week 48)

    Measured: At week 48 (End of Study)

Secondary outcomes (14)

  1. Percentage of Subjects With Normalised IGF-1 Levels (Age and Sex Adjusted)

    The criterion for a subject is satisfied if he has a normalised IGF-1 level (age and sex adjusted) at week 24.

    Measured: At week 24

  2. Percentage of Subjects Having Maintained an Injection Interval of Six Weeks or Increasing Their Injection Interval to Eight Weeks

    The criterion for a subject is satisfied if he maintained an injection interval of six weeks or increasing his injection interval to eight weeks during Phase 2 of the study.

    Measured: During phase 2 of the study (up to week 48)

  3. Percentage of Subjects Who Extend Their Injection Interval to Eight Weeks During Phase 2 of the Study, Whilst Maintaining Normalised IGF-1 Levels

    The criterion for a subject is satisfied if he extended his injection interval to eight weeks during Phase 2 of the study, whilst maintaining normalised IGF-1 levels at Week 48.

    Measured: At week 48

  4. Mean Change From Baseline in IGF-1 Values [Expressed as % of Upper Limit of Normal (ULN)], Overall and by Injection Interval

    IGF-1 change from Baseline to Week 48 = Mean IGF-1 level at Week 48 - Mean IGF-1 level at Baseline

    Measured: Baseline (visit 1) and week 48

  5. Treatment Group (A, B or C) Mean Baseline IGF-1 Levels (Expressed as % of ULN) in Subjects Who Maintained Normalised IGF-1 Values at Week 48. Comparisons Will be Made as Follows: A Versus B, A Versus C, A Versus (B+C) and B Versus C

    Measured: Baseline (visit 1)

  6. Mean Baseline IGF-1 Levels (Expressed as % of ULN) in All Groups (A, B and C) Versus Mean Baseline IGF-1 Levels (Expressed as % of ULN) in Subjects With Uncontrolled IGF-1 Levels at Week 24

    Measured: Baseline (visit 1)

  7. Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia)

    Acromegaly symptoms were assessed by the patients using the Patient Assessed Acromegaly Symptom Questionnaire (PASQ) scale ranging from 0 (No symptoms) to 8 (Severe, incapacitating symptoms).

    Measured: At baseline, week 24 and week 48

  8. Mean Changes From Baseline in Quality of Life Scores (AcroQoL)

    AcroQoL score groups 22 components: Eight physical, Seven psychological appearance and Seven psychological personal relations, adjusted to a scale of 100, where a score of 100 corresponds to the best possible QoL and 0 to the worst.

    Measured: At weeks 24 and 48

  9. Mean Changes From Baseline in Quality of Life Scores (SF-36)

    Short Form-36 questionnaire (SF-36) score comprises eight components: Physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health on a scale of 100, where a score of 100 corresponds to the best possible QoL and 0 to the worst.

    Measured: At weeks 24 and 48

  10. Percentage of Subjects With Normalized IGF-1 Levels (Age and Sex Adjusted), Without Any Worsening of the AcroQoL Change Score Between Inclusion and Week 48

    The criterion for a subject is satisfied if he had a IGF-1 level (age and sex adjusted) without any worsening of the AcroQoL change score between Inclusion and Week 48.

    Measured: At week 48 (End of Study)

  11. Correlation Between the Changes From Baseline in Quality of Life (AcroQoL) With the Corresponding Changes in IGF-1 Level (Expressed as % of ULN) at Each Visit

    AcroQoL change from Baseline to Week 24 (48) = AcroQoL at Week 24 (48) - AcroQoL at Baseline.

    IGF-1 change from Baseline to Week 24 (48) = IGF-1 at Week 24 (48) - IGF-1 at Baseline.

    Correlation presented is a Spearman correlation (non parametric).

    Measured: At weeks 24 and 48

  12. Serum Growth Hormone (GH) Levels

    Measured: At Baseline, week 24 and week 48

  13. Percentage of Subjects With GH Level Less Than or Equal to 2.5 ng/mL

    Measured: At weeks 24 and 48

  14. Subject Treatment Schedule Preference

    At week 24, the preference assessed between Octreotide Long Acting Repeatable intramuscular injection (Oct-LAR IM) every 4 weeks and Lanreotide Autogel 120 mg subcutaneous injection (SC) every 6 weeks.

    At week 48, the preference is assessed between Oct-LAR IM every 4 weeks and Lanreotide Autogel 120 mg SC either injected every 4, 6 or 8 weeks (as injected during Phase II of the study).

    Measured: At weeks 24 and 48

Timeline

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

  1. First posted19 Jun 2008 (estimated)
  2. Study startOct 2008
  3. Primary completionMar 2013
  4. Study completionMay 2013

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 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
124 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00701363
Sponsor's protocol ID
A-38-52030-214
Other IDs
2007-005838-37
Acronym
LEAD
Status last verified
Jan 2019
First submitted
18 Jun 2008
Last updated
29 Jan 2019

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Lanreotide Autogel 120 mg in people with Acromegaly, run by Ipsen at 44 sites in 14 countries.

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 5 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 29 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites in France, Greece, Denmark, Poland, South Korea and 9 more countries. 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?

Yes. Results are posted in the registry (first posted 14 Dec 2015). 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 Subjects Having Maintained Their Injection Interval Schedule of Six Weeks or Increased Their Injection Interval to Eight Weeks Whilst Keeping Their Normalised Insulin Growth Factor (IGF-1) Levels (Age and Sex Adjusted) (time frame: At week 48 (End of Study)). 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 NCT00701363.

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 29 Jan 2019.

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