Cushing's DiseasePhase 3NCT00889525
Study of Cabergoline in Treatment of Corticotroph Pituitary Tumor
A Phase 3 study testing Cabergoline in people with Cushing's Disease and Corticotroph Adenoma, run by Seth Gordhandas Sunderdas Medical College at 1 site in India.
Trial summary
This study was designed to check the efficacy of a new oral medical drug treatment, namely Cabergoline, for the treatment of Cushing Disease due to pituitary adenoma. Background: Cabergoline is a Dopamine 2 receptor agonist. Corticotroph adenoma has shown to have the D2 receptor in in vitro studies. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Cushing's Disease, Corticotroph Adenoma
- What is being tested?
- Cabergoline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteIndia
- Study dates
- Nov 2007to not given
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient with Cushing's disease uncured biochemically after pituitary surgery with adenoma on histopathology
Who cannot join
- Patient's intolerance to drug or known sensitivity to ergot derivatives
- Pregnancy, lactation or female wishing to be pregnant
- Any serious medical illness
- Patient on any drugs known to have an interaction with cabergoline including antihypertensives like reserpine and methyl dopa, neuroleptics, metoclopramide, etc
Trial locations and contacts
1 site in 1 country.
About this study
This study was designed to check the efficacy of a new oral medical drug treatment, namely Cabergoline, for the treatment of Cushing Disease due to pituitary adenoma.
Background: Cabergoline is a Dopamine 2 receptor agonist. Corticotroph adenoma has shown to have the D2 receptor in in vitro studies.
- Conditions
- Cushing's Disease, Corticotroph Adenoma
- Being tested
- Cabergoline
- Keywords
- Cabergoline
- Medical subject headings
- Pituitary ACTH Hypersecretion, ACTH-Secreting Pituitary Adenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CabergolineDrug
Dose 1 mg/week in divided doses, increased by 1 mg/week every month, to the maximum of 5 mg/week. If response is seen than the dose at which response is seen is continued until the end of the study.
| Study group | Role | What they receive |
|---|---|---|
| Cabergoline | Experimental | Not described Receives: Drug: Cabergoline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response in term of mid night cortisol < 5.0 mcg/dl and/or Standard two day dexamethasone suppression test < 1.8 mcg/dl
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2009 (estimated)
- Study startNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cushing's DiseaseStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Seth Gordhandas Sunderdas Medical College
- Sponsor type
- University, hospital or other
- Investigators
- Nalini S Shah, DM, Principal investigator, Seth GSMC and KEM hospital, Mumbai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00889525
- Sponsor's protocol ID
- EC/104/2005
- Status last verified
- Apr 2009
- First submitted
- 27 Apr 2009
- Last updated
- 29 Apr 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Cabergoline in Treatment of Corticotroph Pituitary Tumor
- ClinicalTrials.gov ID
- NCT00889525
- Acronym / sponsor ID
- EC/104/2005
- Conditions
- Cushing's Disease, Corticotroph Adenoma
- Keywords
- Cabergoline
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Seth Gordhandas Sunderdas Medical CollegeUniversity, hospital or other
- Study start
- Nov 2007
- First posted
- 29 Apr 2009 (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.
This study was designed to check the efficacy of a new oral medical drug treatment, namely Cabergoline, for the treatment of Cushing Disease due to pituitary adenoma.
Background: Cabergoline is a Dopamine 2 receptor agonist. Corticotroph adenoma has shown to have the D2 receptor in in vitro studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cabergoline | Experimental | Drug: Cabergoline |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patient with Cushing's disease uncured biochemically after pituitary surgery with adenoma on histopathology
Key exclusion criteria (4 listed)
- Patient's intolerance to drug or known sensitivity to ergot derivatives
- Pregnancy, lactation or female wishing to be pregnant
- Any serious medical illness
- Patient on any drugs known to have an interaction with cabergoline including antihypertensives like reserpine and methyl dopa, neuroleptics, metoclopramide, etc
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 |
|---|---|---|
| CabergolineDose 1 mg/week in divided doses, increased by 1 mg/week every month, to the maximum of 5 mg/week. If response is seen than the dose at which response is seen is continued until the end of the study. | Drug | Cabergoline |
Primary outcome
Response in term of mid night cortisol < 5.0 mcg/dl and/or Standard two day dexamethasone suppression test < 1.8 mcg/dl
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 29 Apr 2009.
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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.
Nalini S Shah, DM principal investigator
Seth GSMC and KEM hospital, Mumbai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cabergoline in people with Cushing's Disease and Corticotroph Adenoma, run by Seth Gordhandas Sunderdas Medical College at 1 site in India.
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 1 inclusion and 4 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 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. 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?
Response in term of mid night cortisol < 5.0 mcg/dl and/or Standard two day dexamethasone suppression test < 1.8 mcg/dl. 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 29 Apr 2009.