Ultrasound Guided Sandostatin LAR Injection in Acromegaly
The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Cedars-Sinai Medical Center.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Cedars-Sinai Medical Center
Collaborator:
Novartis Pharmaceuticals
Information provided by:
Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
NCT00552071
First received: October 31, 2007
Last updated: August 18, 2010
Last verified: August 2010
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Purpose
The purpose of this study is to determine the difference in drug levels of Sandostatin after IM injection of Sandostatin LAR without ultrasound guidance (as is the standard of care) compared to drug levels of Sandostatin after IM injection of Sandostatin LAR with ultrasound guidance in subjects with Acromegaly.
| Condition | Intervention |
|---|---|
|
Acromegaly |
Drug: Sandostatin LAR |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Does Ultrasound-Guidance Improve the Delivery and Efficacy of Intramuscular (IM) Injection of Sandostatin LAR in the Treatment of Acromegaly |
Resource links provided by NLM:
Further study details as provided by Cedars-Sinai Medical Center:
Primary Outcome Measures:
- Serum drug levels of octreotide after third month of ultrasound guided IM injection of octreotide LAR compared to third month of non-ultrasound guided IM injection of octreotide LAR [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- IGF-I levels after ultrasound guided octreotide LAR injection compared to non-ultrasound guided injections [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 20 |
| Study Start Date: | July 2007 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1
3 months of ultrasound guided IM injections of octreotide LAR followed by 3 months of non-ultrasound guided injections of octreotide LAR
|
Drug: Sandostatin LAR
use of consistent monthly dose of medication for duration of 6 months.
Other Name: Ultrasound guided Sandostatin LAR injection
Drug: Sandostatin LAR
All patients receive Sandostatin LAR throughout trial at a fixed dose established at entry into the study.
|
|
2
3 months of non-ultrasound guided octreotide LAR IM injections followed by ultrasound guided IM injections of LAR
|
Drug: Sandostatin LAR
All patients receive Sandostatin LAR throughout trial at a fixed dose established at entry into the study.
|
Detailed Description:
IM intragluteal injections have been reported to be inaccurate in their placement in the intramuscular compartment when performed as dictated by the current standard of care. This inaccuracy of placement may have an effect on the efficacy of drugs delivered by the IM route. Furthermore, the inaccuracy of IM injections was found to be directly related to BMI and was found to be more inaccurate in female subjects. Ultrasound guidance of IM injections will improve the accuracy of placement of IM injections and may improve drug levels and efficacy of Sandostatin LAR in the treatment of Acromegaly.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male and female patients ≥18 years old
- Patients with active acromegaly due to a pituitary adenoma. Historical data indicating a diagnosis of acromegaly based on circulating IGF-I concentration elevated compared to age and gender matched controls OR GH >1 mcg/l at 120 Minutes of a two hour OGTT.
- Currently being treated with Sandostatin LAR and have been treated with a stable dose for 3 months prior to entry into the study.
- Patients with diabetes may be included, blood glucose and diabetic treatments are to be monitored closely during the trial in these subjects
- Patients have provided written informed consent
Exclusion Criteria:
- Uncontrolled diabetes mellitus
- Patients who are pregnant or lactating
- Patients who have a known hypersensitivity to Sandostatin acetate or other related drug or compound
- Patients with current gallstones
- Patients with a past or current history of cancer, except for basal cell carcinoma or in situ cancer of the cervix
- Patients with a history of hepatic disease (patients with minimal, i.e., <3Xs the upper limit of normal for LFTs indicative of hepatic steatosis, MAY participate)
- Patients who have received glucocorticoid therapy within the past 6 months, or who are currently receiving any chemotherapeutic agents, or exogenous growth hormone therapy
- Patients who have received other investigational drugs administered or received within 30 days of study entry
- Patients with unacceptable concomitant diagnoses, or who have received medications and/or therapies (i.e., any concomitant illnesses or therapies that would place the patient at increased risk, or would, in the opinion of the investigator or sponsor, interfere with the evaluation of efficacy or safety) Interruption or discontinuation of treatment
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00552071
Contacts
| Contact: Billy Gellepis | (310) 423-3395 | gellepisw@cshs.org |
| Contact: Lori Korsakoff, RN, BSN | (310) 423-2411 | korsakoffl@cshs.org |
Locations
| United States, California | |
| Cedars-Sinai Medical Center | Recruiting |
| Los Angeles, California, United States, 90048 | |
| Principal Investigator: John D Carmichael, MD | |
| Sub-Investigator: Shlomo Melmed, MD | |
| Sub-Investigator: Vivien Bonert, MD | |
Sponsors and Collaborators
Cedars-Sinai Medical Center
Novartis Pharmaceuticals
Investigators
| Principal Investigator: | John D Carmichael, MD | Cedars-Sinai Medical Center |
More Information
No publications provided
| Responsible Party: | John Carmichael, MD, Cedars-Sinai Medical Center, Pituitary Center |
| ClinicalTrials.gov Identifier: | NCT00552071 History of Changes |
| Other Study ID Numbers: | 11482, CSMS995BUS60 |
| Study First Received: | October 31, 2007 |
| Last Updated: | August 18, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Cedars-Sinai Medical Center:
|
Acromegaly Octreotide LAR Ultrasound guidance |
Additional relevant MeSH terms:
|
Acromegaly Bone Diseases, Endocrine Bone Diseases Musculoskeletal Diseases Hyperpituitarism Pituitary Diseases Hypothalamic Diseases Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Endocrine System Diseases Octreotide Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Gastrointestinal Agents |
ClinicalTrials.gov processed this record on June 18, 2013