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Surgical Debulking of Pituitary Adenomas

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ClinicalTrials.gov Identifier: NCT01371643
Recruitment Status : Completed
First Posted : June 13, 2011
Results First Posted : July 22, 2016
Last Update Posted : August 29, 2016
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label)
Condition Pituitary Adenoma
Interventions Drug: Octreotide LAR
Procedure: transsphenoidal surgery
Enrollment 41
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Medical Treatment by Octreotide LAR Surgical Debulking Followed by Octreotide LAR
Hide Arm/Group Description

Medical therapy with Octreotide LAR 30 mg/month for 3 months preceding surgery

Octreotide LAR

Surgical debulking of pituitary tumor followed by Octreotide LAR if not surgically cured

Octreotide LAR

transsphenoidal surgery

Period Title: Overall Study
Started 15 26
Completed 12 26
Not Completed 3 0
Reason Not Completed
Withdrawal by Subject             3             0
Arm/Group Title Medical Treatment by Octreotide LAR Surgical Debulking Followed by Octreotide LAR Total
Hide Arm/Group Description

Medical therapy with Octreotide LAR 30 mg/month for 3 months preceding surgery

Octreotide LAR

Surgical debulking of pituitary tumor followed by Octreotide LAR if not surgically cured

Octreotide LAR

transsphenoidal surgery

Total of all reporting groups
Overall Number of Baseline Participants 15 26 41
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 26 participants 41 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
14
  93.3%
25
  96.2%
39
  95.1%
>=65 years
1
   6.7%
1
   3.8%
2
   4.9%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 26 participants 41 participants
Female
5
  33.3%
12
  46.2%
17
  41.5%
Male
10
  66.7%
14
  53.8%
24
  58.5%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 15 participants 26 participants 41 participants
American Indian or Alaskan 0 0 0
Asian or Pacific Islander 1 2 3
Black, Not of Hispanic-American Origin 1 1 2
Hispanic-American 0 0 0
White, not of Hispanic-American Origin 10 21 31
Other or Unknown 3 2 5
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 15 participants 26 participants 41 participants
United States 8 14 22
Germany 5 8 13
Italy 2 4 6
1.Primary Outcome
Title Percentage of Responders (Primary Medical Treatment in Arm 1, Primary Surgical Treatment in Arm 2)
Hide Description Nadir growth hormone <1 ng/mL during a standard 2 hour oral glucose tolerance test using 75 g glucose and normal IGF-I according to age and gender-matched standards.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Medical Treatment by Octreotide LAR Surgical Debulking Followed by Octreotide LAR
Hide Arm/Group Description:

Medical therapy with Octreotide LAR 30 mg/month for 3 months preceding surgery

Octreotide LAR

Surgical debulking of pituitary tumor followed by Octreotide LAR if not surgically cured

Octreotide LAR

transsphenoidal surgery

Overall Number of Participants Analyzed 15 26
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
6.7
(.2 to 31.9)
50
(29.9 to 70.1)
2.Primary Outcome
Title Percentage of Responders (All Treatments)
Hide Description Nadir growth hormone <1 ng/mL during a standard 2 hour oral glucose tolerance test using 75 g glucose and normal IGF-I according to age and gender-matched standards.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Medical Treatment by Octreotide LAR Surgical Debulking Followed by Octreotide LAR
Hide Arm/Group Description:

Medical therapy with Octreotide LAR 30 mg/month for 3 months preceding surgery

Octreotide LAR

Surgical debulking of pituitary tumor followed by Octreotide LAR if not surgically cured

Octreotide LAR

transsphenoidal surgery

Overall Number of Participants Analyzed 15 26
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
6.7
(.2 to 31.9)
76.9
(56.4 to 91)
3.Secondary Outcome
Title Percentage of Responders (Only Including Surgical Failures in Arm 2)
Hide Description Nadir growth hormone <1 ng/mL during a standard 2 hour oral glucose tolerance test using 75 g glucose and normal IGF-I according to age and gender-matched standards.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Medical Treatment by Octreotide LAR Surgical Debulking Followed by Octreotide LAR
Hide Arm/Group Description:

Medical therapy with Octreotide LAR 30 mg/month for 3 months preceding surgery

Octreotide LAR

Surgical debulking of pituitary tumor followed by Octreotide LAR if not surgically cured

Octreotide LAR

transsphenoidal surgery

Overall Number of Participants Analyzed 15 13
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
6.7
(.2 to 31.9)
53.9
(25.1 to 80.8)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Medical Treatment by Octreotide LAR Surgical Debulking Followed by Octreotide LAR
Hide Arm/Group Description

Medical therapy with Octreotide LAR 30 mg/month for 3 months preceding surgery

Octreotide LAR

Surgical debulking of pituitary tumor followed by Octreotide LAR if not surgically cured

Octreotide LAR

transsphenoidal surgery

All-Cause Mortality
Medical Treatment by Octreotide LAR Surgical Debulking Followed by Octreotide LAR
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Medical Treatment by Octreotide LAR Surgical Debulking Followed by Octreotide LAR
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/15 (0.00%)      1/26 (3.85%)    
General disorders     
Hyponatremia with Abdominal Discomfort  0/15 (0.00%)  1/26 (3.85%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Medical Treatment by Octreotide LAR Surgical Debulking Followed by Octreotide LAR
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/15 (33.33%)      12/26 (46.15%)    
Ear and labyrinth disorders     
Otitis Media  1/15 (6.67%)  1 0/26 (0.00%)  0
Endocrine disorders     
Thyroiditis  0/15 (0.00%)  0 1/26 (3.85%)  1
Gastrointestinal disorders     
Nausea/Vomiting/Diarrhea/Bloating/Constipation/GI distress  2/15 (13.33%)  7 9/26 (34.62%)  19
General disorders     
Dry nose  1/15 (6.67%)  1 0/26 (0.00%)  0
Fatigue  2/15 (13.33%)  3 2/26 (7.69%)  3
Sinus irritation/pressure  0/15 (0.00%)  0 2/26 (7.69%)  2
Dizziness  0/15 (0.00%)  0 3/26 (11.54%)  3
Arm Weakness/Numbing  0/15 (0.00%)  0 1/26 (3.85%)  2
Muscle ache  0/15 (0.00%)  0 1/26 (3.85%)  1
Infections and infestations     
Respiratory Infections/Cold symptoms/ Cough  0/15 (0.00%)  0 2/26 (7.69%)  5
Musculoskeletal and connective tissue disorders     
Back Pain  0/15 (0.00%)  0 1/26 (3.85%)  1
Joint Pain  0/15 (0.00%)  0 1/26 (3.85%)  1
Nervous system disorders     
Headaches  1/15 (6.67%)  1 6/26 (23.08%)  7
Seizures (Seizure disorder since childhood)  1/15 (6.67%)  1 0/26 (0.00%)  0
Psychiatric disorders     
Depression  0/15 (0.00%)  0 1/26 (3.85%)  1
Renal and urinary disorders     
Urinary Tract Infection  0/15 (0.00%)  0 1/26 (3.85%)  1
Respiratory, thoracic and mediastinal disorders     
Nosebleed  0/15 (0.00%)  0 1/26 (3.85%)  2
Surgical and medical procedures     
Pain at the Injection site  0/15 (0.00%)  0 2/26 (7.69%)  2
Planned excision of occipital skin tumor  0/15 (0.00%)  0 1/26 (3.85%)  1
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: David Kleinberg
Organization: NYU Langone Medical Center
Phone: 212 263 6772
EMail: David.Kleinberg@nyumc.org
Layout table for additonal information
Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT01371643     History of Changes
Other Study ID Numbers: R11104
First Submitted: June 9, 2011
First Posted: June 13, 2011
Results First Submitted: February 5, 2016
Results First Posted: July 22, 2016
Last Update Posted: August 29, 2016