Trial Outcomes & Findings for Long-term Safety Study of Sublingual Fentanyl Tablets in Cancer Patients (NCT NCT00263575)
NCT ID: NCT00263575
Last Updated: 2024-06-18
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
139 participants
Primary outcome timeframe
screening, 2 week titration period and 12 monthly study visits
Results posted on
2024-06-18
Participant Flow
Recruitment period was first patient screened in December 2005 to last patient screened in November 2008. Patients were recruited from Medical Institutions in the US.
Patients with stable cancer-related pain receiving stable, fixed-schedule oral opioid regimen. Patients were not permitted to have 2 consecutive days without at least 1 episode of BTcP. This regimen was for 14 days prior to screening and was expected to remain unchanged for the titration period. Patients with ulcerative mucositis were permitted.
Participant milestones
| Measure |
Sublingual Fentanyl Tablet
EN3267 : EN3267 will be available in 100, 200, 300, 400, 600 (two 300 ug tablets), and 800 ug (two 400 ug tablets) doses
|
|---|---|
|
Titration Period
STARTED
|
139
|
|
Titration Period
COMPLETED
|
96
|
|
Titration Period
NOT COMPLETED
|
43
|
|
Maintence Period
STARTED
|
96
|
|
Maintence Period
COMPLETED
|
19
|
|
Maintence Period
NOT COMPLETED
|
77
|
Reasons for withdrawal
| Measure |
Sublingual Fentanyl Tablet
EN3267 : EN3267 will be available in 100, 200, 300, 400, 600 (two 300 ug tablets), and 800 ug (two 400 ug tablets) doses
|
|---|---|
|
Titration Period
Adverse Event
|
14
|
|
Titration Period
Withdrawal by Subject
|
10
|
|
Titration Period
Protocol Violation
|
9
|
|
Titration Period
Sponsor Decision
|
2
|
|
Titration Period
Other
|
2
|
|
Titration Period
Lack of Efficacy
|
6
|
|
Maintence Period
Adverse Event
|
23
|
|
Maintence Period
Withdrawal by Subject
|
8
|
|
Maintence Period
Protocol Violation
|
4
|
|
Maintence Period
Lack of Efficacy
|
4
|
|
Maintence Period
Physician Decision
|
6
|
|
Maintence Period
Lost to Follow-up
|
1
|
|
Maintence Period
Sponsor Decision
|
24
|
|
Maintence Period
Other
|
7
|
Baseline Characteristics
Long-term Safety Study of Sublingual Fentanyl Tablets in Cancer Patients
Baseline characteristics by cohort
| Measure |
Sublingual Fentanyl Tablet
n=139 Participants
EN3267 : EN3267 will be available in 100, 200, 300, 400, 600 (two 300 ug tablets), and 800 ug (two 400 ug tablets) doses
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
106 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
33 Participants
n=5 Participants
|
|
Age, Continuous
|
57 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
76 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
63 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
139 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: screening, 2 week titration period and 12 monthly study visitsOutcome measures
| Measure |
Titration
n=139 Participants
EN3267: EN3267 will be available in 100, 200, 300, 400, 600 (two 300 ug tablets), and 800 ug (two 400 ug tablets) doses
|
Maintenance
n=96 Participants
All patients enrolled who continued into the maintenance period
|
Overall
n=139 Participants
Combination of titration and maintenance period
|
|---|---|---|---|
|
Evaluate the Long-term Safety and Effectiveness of EN3267
Patients with at least 1 AE
|
64 participants
|
87 participants
|
116 participants
|
|
Evaluate the Long-term Safety and Effectiveness of EN3267
Patients with at least 1 AE causing discontinue
|
14 participants
|
23 participants
|
37 participants
|
|
Evaluate the Long-term Safety and Effectiveness of EN3267
Patients with at least 1 SAE
|
7 participants
|
40 participants
|
46 participants
|
|
Evaluate the Long-term Safety and Effectiveness of EN3267
Patients with an AE resulting in death
|
4 participants
|
15 participants
|
19 participants
|
Adverse Events
Sublingual Fentanyl Tablet
Serious events: 46 serious events
Other events: 116 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sublingual Fentanyl Tablet
n=139 participants at risk
EN3267: EN3267 will be available in 100, 200, 300, 400, 600 (two 300 ug tablets), and 800 ug (two 400 ug tablets) doses
|
|---|---|
|
General disorders
death
|
13.7%
19/139
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
3.6%
5/139
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
1.4%
2/139
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
1.4%
2/139
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
1.4%
2/139
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic carcinoma of the bladder
|
1.4%
2/139
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic renal cell carcinoma
|
1.4%
2/139
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.72%
1/139
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic gastric cancer
|
0.72%
1/139
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic pain
|
0.72%
1/139
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer metastatic
|
0.72%
1/139
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Esophageal cancer metastatic
|
0.72%
1/139
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.72%
1/139
|
|
Infections and infestations
Central line infection
|
1.4%
2/139
|
|
Infections and infestations
Pneumonia
|
1.4%
2/139
|
|
Infections and infestations
Bronchitis
|
0.72%
1/139
|
|
Infections and infestations
Candida sepsis
|
0.72%
1/139
|
|
Infections and infestations
Intestinal fistula infection
|
0.72%
1/139
|
|
Infections and infestations
Pneumonia herpes viral
|
0.72%
1/139
|
|
Infections and infestations
Sepsis
|
0.72%
1/139
|
|
Infections and infestations
Wound infection staphylococcal
|
0.72%
1/139
|
|
Blood and lymphatic system disorders
Anemia
|
2.2%
3/139
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.2%
3/139
|
|
Blood and lymphatic system disorders
Pancytopenia
|
1.4%
2/139
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.72%
1/139
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.4%
2/139
|
|
Respiratory, thoracic and mediastinal disorders
Alveolitis allergic
|
0.72%
1/139
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructed airway disease
|
0.72%
1/139
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.72%
1/139
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.72%
1/139
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.72%
1/139
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.72%
1/139
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.72%
1/139
|
|
Cardiac disorders
Acute coronary syndrome
|
0.72%
1/139
|
|
Cardiac disorders
Cardiac failure congestive
|
0.72%
1/139
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.72%
1/139
|
|
Cardiac disorders
Myocardial ischaemia
|
0.72%
1/139
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.72%
1/139
|
|
Cardiac disorders
Ventricular tachycardia
|
0.72%
1/139
|
|
Metabolism and nutrition disorders
Dehydration
|
4.3%
6/139
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.72%
1/139
|
|
General disorders
Pain
|
2.2%
3/139
|
|
General disorders
Asthenia
|
0.72%
1/139
|
|
General disorders
Infusion site reaction
|
0.72%
1/139
|
|
Nervous system disorders
Convulsion
|
1.4%
2/139
|
|
Nervous system disorders
Dizziness
|
0.72%
1/139
|
|
Nervous system disorders
Dyskinesia
|
0.72%
1/139
|
|
Vascular disorders
Deep vein thrombosis
|
0.72%
1/139
|
|
Vascular disorders
Hypotension
|
0.72%
1/139
|
|
Vascular disorders
Orthostatic hypotension
|
0.72%
1/139
|
|
Vascular disorders
Subclavian vein thrombosis
|
0.72%
1/139
|
|
Gastrointestinal disorders
Abdominal pain
|
0.72%
1/139
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.72%
1/139
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.72%
1/139
|
|
Hepatobiliary disorders
Cholecystitis
|
1.4%
2/139
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.72%
1/139
|
|
Injury, poisoning and procedural complications
Radiation pneumonitis
|
0.72%
1/139
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.72%
1/139
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.72%
1/139
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.72%
1/139
|
|
Renal and urinary disorders
Azotemia
|
0.72%
1/139
|
|
Renal and urinary disorders
Hematuria
|
0.72%
1/139
|
|
Renal and urinary disorders
Obstructive uropathy
|
0.72%
1/139
|
|
Renal and urinary disorders
Renal failure acute
|
0.72%
1/139
|
|
Immune system disorders
Immunosuppression
|
0.72%
1/139
|
|
Skin and subcutaneous tissue disorders
Leukocytoclastic vasculitis
|
0.72%
1/139
|
Other adverse events
| Measure |
Sublingual Fentanyl Tablet
n=139 participants at risk
EN3267: EN3267 will be available in 100, 200, 300, 400, 600 (two 300 ug tablets), and 800 ug (two 400 ug tablets) doses
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
23.0%
32/139
|
|
Gastrointestinal disorders
Vomiting
|
12.9%
18/139
|
|
Gastrointestinal disorders
Constipation
|
8.6%
12/139
|
|
Gastrointestinal disorders
Diarrhea
|
7.9%
11/139
|
|
Gastrointestinal disorders
Stomatitis
|
7.9%
11/139
|
|
Gastrointestinal disorders
Abdominal pain
|
5.8%
8/139
|
|
Gastrointestinal disorders
Dry mouth
|
5.8%
8/139
|
|
General disorders
Fatigue
|
15.1%
21/139
|
|
General disorders
Edema peripheral
|
10.8%
15/139
|
|
General disorders
Asthenia
|
8.6%
12/139
|
|
Nervous system disorders
Somnolence
|
7.9%
11/139
|
|
Nervous system disorders
Dizziness
|
7.2%
10/139
|
|
Nervous system disorders
Headache
|
6.5%
9/139
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
7.9%
11/139
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.1%
14/139
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.4%
13/139
|
|
Investigations
Weight decreased
|
5.8%
8/139
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.0%
7/139
|
|
Metabolism and nutrition disorders
Dehydration
|
11.5%
16/139
|
|
Metabolism and nutrition disorders
Anorexia
|
7.9%
11/139
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.0%
7/139
|
|
Blood and lymphatic system disorders
Anemia
|
7.2%
10/139
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.0%
7/139
|
|
Psychiatric disorders
Insomnia
|
9.4%
13/139
|
|
Psychiatric disorders
Anxiety
|
5.8%
8/139
|
|
Psychiatric disorders
Depression
|
5.8%
8/139
|
|
Vascular disorders
Hypotension
|
5.8%
8/139
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Publication statement in clinical trial agreement
- Publication restrictions are in place
Restriction type: OTHER