AcromegalyACRO-OPTIMNCT02698384
Therapeutic Strategies in Acromegalic Subjects Treated With Lanreotide 120mg
An observational study of Acromegaly, run by Ipsen at 10 sites in France.
Trial summary
The study aims to evaluate the biochemical and clinical effectiveness on symptoms and tumor size of a monotherapy with Lanreotide 120mg in acromegalic subjects, to describe criteria for starting alternative strategies, and to describe the modalities and the global effectiveness of alternative strategies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acromegaly
- How many people
- 4 participants
- Where
- 10 sitesFrance
- Study dates
- Jan 2016to Jun 2016
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Acromegalic subjects
Who may be able to join
- Male or female aged 18 years or more, suffering from acromegaly
- Treatment naïve or treated subject (whatever the previous treatments except Lanreotide 120mg and radiotherapy) who does not achieve biochemical control in the physician's opinion. Requiring a treatment with Somatostatin analog (SSA)
- Having performed a Magnetic Resonance Imaging (MRI) to evaluate the tumor size within the previous 12 weeks (post-surgery MRI for operated subjects)
- In whom the physician has already decided to initiate a treatment with Lanreotide 120mg as a monotherapy
Who cannot join
- Subject previously/currently treated with Lanreotide 120mg
- History of radiotherapy for acromegaly
- Subject who requires a surgical intervention for relief of any sign or symptom associated with tumor compression
- Concomitant prolactin hypersecretion requiring a treatment with dopaminergic agonists
- Active neoplastic disease
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
Hoptial Nord
Amiens, 80054
Hopital jean Minjoz
Besançon, 25030
Hopital Neuro-Cardiologique, Fédération d'Endocrinologie
Bron, 69677
Hopital Albert Michallon
La Tronche, 38700
Hopital De La Conception
Marseille, 13005
Hopital Haut Leveque
Pessac, 33604
Hopital Robert Debre
Reims, 51092
Hopital Nord
Saint-Etienne, 42055
Hopital De Hautepierre
Strasbourg, 67098
Hopital Larrey
Toulouse, 31059
About this study
Official title: Optimisation of Therapeutic Strategies in Acromegalic Subjects Treated With Lanreotide 120mg
The study aims to evaluate the biochemical and clinical effectiveness on symptoms and tumor size of a monotherapy with Lanreotide 120mg in acromegalic subjects, to describe criteria for starting alternative strategies, and to describe the modalities and the global effectiveness of alternative strategies.
- Conditions
- Acromegaly
- Medical subject headings
- Acromegaly
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects who achieve a safe concentration of random Growth Hormone (GH) (≤2.5 ng/mL) and normal age and sex-matched Insulin-like Growth Factor-1 (IGF-1) concentration of the monotherapy phase.
Measured: Month 5
Secondary outcomes (15)
Profile of subjects
Description of demographics, Patient-Assessed Acromegaly Symptom Questionnaire (PASQ) clinical score, PASQ overall health status, tumor volume, comorbidities, GH and IGF-1 levels
Measured: Baseline
History of acromegaly
Description of the date of diagnosis, GH and IGF-1 levels and tumor volume at diagnosis
Measured: Baseline
History of treatment
Description between the diagnosis of acromegaly and the 1st injection of Lanreotide 120mg (treatments, doses)
Measured: Baseline
Achievement of safe concentration of random GH (≤2.5 ng/mL) and normal age- and sex-matched IGF-1 concentrations of the monotherapy phase
Measured: Month 12 and 18
Raw values at each visit and change from baseline in random Growth Hormone (GH)
Measured: Baseline, month 5, 12 and 18
Raw values at each visit and change from baseline in overall health status (Patient-Assessed Acromegaly Symptom Questionnaire - PASQ) of the monotherapy phase
Measured: Baseline, month 5, 12 and 18
Raw values at each visit and change from baseline in the Acromegaly Quality of Life Questionnaire (ACROQoL total score and each dimension) of the monotherapy phase
Measured: Baseline, month 5, 12 and 18
Description of the GH and Insulin-like Growth Factor-1 (IGF-1) levels when the physician decides to start the first alternative strategy
Assessed in the alternate strategy phase
Measured: Day 1 (Visit 5)
Proportion of subjects achieving biochemical control (random GH ≤2.5 ng/mL and normal age- and sex-matched IGF-1 concentrations) at month 18 time point of the alternative strategy phase (18 months after the start of the first alternative strategy)
Measured: Month 18
Number of alternative strategies used during the alternative strategy phase
Measured: Month 18
Treatments received at least once during the alternative strategy phase
Measured: Month 18
Proportion of subjects with clinically relevant tumor shrinkage (tumor volume decrease of ≥ 20% versus V1 (month 0) of the monotherapy phase) at V6 (month 18 time point) of the alternative strategy phase
Measured: Month 18
Change in clinical score (PASQ) between baseline (month 0) of the monotherapy phase and month 18 time point of the alternative strategy phase
Measured: Month 18
Change in overall health status (PASQ) between baseline (month 0) of the monotherapy phase and month 18 time point of the alternative phase
Measured: Month 18
Change in Acromegaly Quality of Life Questionnaire (ACROQoL total score and dimensions) between baseline (month 0) of the monotherapy phase and Month 18 time point of the alternative strategy phase
Measured: Month 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2016 (estimated)
- Study startJan 2016
- Primary completionJan 2016
- Study completionJun 2016
Why it stopped: The study was terminated early due to insufficient potential for recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcromegalyStudies of the same condition, open and under way.
- More trials run by IpsenThe 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
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02698384
- Sponsor's protocol ID
- A-54-52030-315
- Acronym
- ACRO-OPTIM
- Status last verified
- Dec 2018
- First submitted
- 26 Feb 2016
- Last updated
- 21 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimisation of Therapeutic Strategies in Acromegalic Subjects Treated With Lanreotide 120mg
- ClinicalTrials.gov ID
- NCT02698384
- Acronym / sponsor ID
- ACRO-OPTIM / A-54-52030-315
- Conditions
- Acromegaly
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study was terminated early due to insufficient potential for recruitment.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 3 Mar 2016 (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 aims to evaluate the biochemical and clinical effectiveness on symptoms and tumor size of a monotherapy with Lanreotide 120mg in acromegalic subjects, to describe criteria for starting alternative strategies, and to describe the modalities and the global effectiveness of alternative strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acromegalic subjects
Key inclusion criteria (4 listed)
- Male or female aged 18 years or more, suffering from acromegaly
- Treatment naïve or treated subject (whatever the previous treatments except Lanreotide 120mg and radiotherapy) who does not achieve biochemical control in the physician's opinion. Requiring a treatment with Somatostatin analog (SSA)
- Having performed a Magnetic Resonance Imaging (MRI) to evaluate the tumor size within the previous 12 weeks (post-surgery MRI for operated subjects)
- In whom the physician has already decided to initiate a treatment with Lanreotide 120mg as a monotherapy
Key exclusion criteria (5 listed)
- Subject previously/currently treated with Lanreotide 120mg
- History of radiotherapy for acromegaly
- Subject who requires a surgical intervention for relief of any sign or symptom associated with tumor compression
- Concomitant prolactin hypersecretion requiring a treatment with dopaminergic agonists
- Active neoplastic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of subjects who achieve a safe concentration of random Growth Hormone (GH) (≤2.5 ng/mL) and normal age and sex-matched Insulin-like Growth Factor-1 (IGF-1) concentration of the monotherapy phase.
Time frame: Month 5
15 secondary outcomes
Profile of subjects
Time frame: Baseline
History of acromegaly
Time frame: Baseline
History of treatment
Time frame: Baseline
Achievement of safe concentration of random GH (≤2.5 ng/mL) and normal age- and sex-matched IGF-1 concentrations of the monotherapy phase
Time frame: Month 12 and 18
Raw values at each visit and change from baseline in random Growth Hormone (GH)
Time frame: Baseline, month 5, 12 and 18
Raw values at each visit and change from baseline in overall health status (Patient-Assessed Acromegaly Symptom Questionnaire - PASQ) of the monotherapy phase
Time frame: Baseline, month 5, 12 and 18
Raw values at each visit and change from baseline in the Acromegaly Quality of Life Questionnaire (ACROQoL total score and each dimension) of the monotherapy phase
Time frame: Baseline, month 5, 12 and 18
Description of the GH and Insulin-like Growth Factor-1 (IGF-1) levels when the physician decides to start the first alternative strategy
Time frame: Day 1 (Visit 5)
Proportion of subjects achieving biochemical control (random GH ≤2.5 ng/mL and normal age- and sex-matched IGF-1 concentrations) at month 18 time point of the alternative strategy phase (18 months after the start of the first alternative strategy)
Time frame: Month 18
Number of alternative strategies used during the alternative strategy phase
Time frame: Month 18
Treatments received at least once during the alternative strategy phase
Time frame: Month 18
Proportion of subjects with clinically relevant tumor shrinkage (tumor volume decrease of ≥ 20% versus V1 (month 0) of the monotherapy phase) at V6 (month 18 time point) of the alternative strategy phase
Time frame: Month 18
Change in clinical score (PASQ) between baseline (month 0) of the monotherapy phase and month 18 time point of the alternative strategy phase
Time frame: Month 18
Change in overall health status (PASQ) between baseline (month 0) of the monotherapy phase and month 18 time point of the alternative phase
Time frame: Month 18
Change in Acromegaly Quality of Life Questionnaire (ACROQoL total score and dimensions) between baseline (month 0) of the monotherapy phase and Month 18 time point of the alternative strategy phase
Time frame: Month 18
Results and safety
The study was stopped early (reason given: The study was terminated early due to insufficient potential for recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2018.
Related trials for Acromegaly
RecruitingPhase 1
A Phase 1 Clinical Trial of NTQ6179 Tablets in Healthy Volunteers
Acromegaly
RecruitingObservational study
An Observational Study of Octreotide Subcutaneous Depot in Patients With Acromegaly
Acromegaly
RecruitingPhase 3
A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs
Acromegaly
RecruitingObservational study
An Investigation of Pituitary Tumors and Related Hypothalmic Disorders
Panhypopituitarism, Gigantism/Acromegaly
Recruiting
Managing Pasireotide-associated Hyperglycaemia in Acromegaly With Ketogenic Diet
Acromegaly Due to Pituitary Adenoma, Hyperglycemia
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.
Ipsen Medical Director study director
Ipsen
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acromegaly, run by Ipsen at 10 sites in France.
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 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: stopped early, as of the sponsor's last update on 21 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. 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?
The study was stopped early (reason given: The study was terminated early due to insufficient potential for recruitment.). Results are not available in the source record.
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 who achieve a safe concentration of random Growth Hormone (GH) (≤2.5 ng/mL) and normal age and sex-matched Insulin-like Growth Factor-1 (IGF-1) concentration of the monotherapy phase. (time frame: Month 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Dec 2018.