A Phase 2 interventional study of SOM230 s.c. in Cushing's Syndrome, sponsored by Novartis Pharmaceuticals. Completed at 5 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-11-07.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 2, Interventional, and Treatment
Among 58 studies in Cushing Syndrome with a site in United States — 14 open to participants now, 17 under way, none of them phase 3. Cushing Syndrome · United States.
Among the 58 studies in Cushing Syndrome with a site in United States, this one is the 22nd largest by enrollment of the 34 interventional ones, is the only one that started in 2004, is one of 17 in phase 2, and was the 15th registered.
123 studies on the registry are indexed under Cushing Syndrome; 42 are open to participants now.
This study's enrollment of 26 is below the median of 44 across 58 interventional studies indexed under Cushing Syndrome.
Browse Cushing Syndrome studies →14 of the 58 studies in Cushing Syndrome with a site in United States are open now, in 7 countries. Each count lists the studies.
Of the 35 Cushing Syndrome studies recruiting now, 14 (40%) set no upper age limit and 10 (29%) stop at 75 or younger; 8 take children under 18; 7 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →58 studies; the count open now beside each. This study's row is marked.
First in 1982; this study’s year is marked. 1 started in 2004.
Median enrollment 35 across the 34 interventional studies, 206 across the 23 observational. Of the 38 that completed or were terminated, 15 (39%) have results posted.
27 of 58 have an industry lead sponsor. The 10 most frequent:
Novartis Pharmaceuticals is the lead sponsor of 2,718 studies on the registry; 221 are open to participants now.
Of its 585 completed or terminated interventional studies of FDA-regulated products, 438 (75%) have results posted.
Novartis Pharmaceuticals has 2 studies filed under Cushing Syndrome — fewer than ten, so there is no comparison to draw.
6 of the studies in Cushing Syndrome with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03364803Memorial Sloan Kettering Cancer CenterCollecting Information About Treatment Results for Patients With Cushing's Syndrome | 2026-11-28 |
| NCT03604198Corcept TherapeuticsExtension Study to Evaluate the Safety of Long-Term Use of Relacorilant in Patients With Cushing Syndrome | 2026-12 |
| NCT07104812Mayo ClinicImpact of 1 mg Osilodrostat Therapy on Mild Autonomous Cortisol Secretion (MACS) | 2027-01 |
| NCT05382156RECORDATI GROUPNon-interventional Study on Osilodrostat in Patients With Endogenous Cushing's Syndrome | 2027-06 |
| NCT03708900RECORDATI GROUPPharmacokinetic (PK), Pharmacodynamic (PD) and Tolerability of Osilodrostat in Pediatric Patients With Cushing's Syndrome | 2027-07-21 |
Among the 58 studies in Cushing Syndrome with a site in United States, from their registry updates:
The study treatment period is 15 days in length and includes patients with pituitary Cushing's disease who are candidates for surgical intervention as well as and patients who have recurrent Cushing's post operatively.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Urinary Free Cortisol after 15 days of treatment
Serum cortisol
ACTH
Clinical manifestations
Pharmacokinetics
Safety
Tolerability
Development of biomarkers
The record gives a start of Apr 2004 and a primary completion of Jun 2006. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Pasireotide