Trial Outcomes & Findings for Study Evaluating the Long-Term Safety of Desvenlafaxine Succinate Sustained-Release (DVS SR) in Subjects With Pain Associated With Diabetic Peripheral Neuropathy (NCT NCT01050218)
NCT ID: NCT01050218
Last Updated: 2023-12-11
Results Overview
The primary efficacy variable was the pain severity score measured on an 11 point NRS on which 0=no pain and 10=worst possible pain. The primary efficacy evaluation was the change from baseline in mean pain score on the NRS.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
237 participants
Primary outcome timeframe
Baseline and 9 months
Results posted on
2023-12-11
Participant Flow
Patients were recruited in the United States from July 2006 to September 2008.
Outpatients must have completed double-blind treatment and all scheduled evaluations in study 3151A5-322 (NCT00283842), with no major protocol violations and no events that, in the opinion of the investigator, would have precluded the subject's entry into the long-term open-label study.
Participant milestones
| Measure |
DVS SR Open Label
Daily dose of 100mg or 200mg at the investigators discretion. Subjects already randomized at a dose of 400mg may continue at that dose level.
|
|---|---|
|
Overall Study
STARTED
|
237
|
|
Overall Study
COMPLETED
|
142
|
|
Overall Study
NOT COMPLETED
|
95
|
Reasons for withdrawal
| Measure |
DVS SR Open Label
Daily dose of 100mg or 200mg at the investigators discretion. Subjects already randomized at a dose of 400mg may continue at that dose level.
|
|---|---|
|
Overall Study
Adverse Event
|
37
|
|
Overall Study
Lack of Efficacy
|
8
|
|
Overall Study
Protocol Violation
|
3
|
|
Overall Study
Withdrawal by Subject
|
18
|
|
Overall Study
Discontinued by sponsor
|
18
|
|
Overall Study
Compliance
|
2
|
|
Overall Study
Failed to return
|
7
|
|
Overall Study
Serious Adverse Event
|
1
|
|
Overall Study
Family emergency
|
1
|
Baseline Characteristics
Study Evaluating the Long-Term Safety of Desvenlafaxine Succinate Sustained-Release (DVS SR) in Subjects With Pain Associated With Diabetic Peripheral Neuropathy
Baseline characteristics by cohort
| Measure |
DVS SR Open Label
n=237 Participants
Daily dose of 100mg or 200mg at the investigators discretion. Subjects already randomized at a dose of 400mg may continue at that dose level.
|
|---|---|
|
Age, Continuous
|
59.84 years
STANDARD_DEVIATION 8.90 • n=99 Participants
|
|
Sex: Female, Male
Female
|
64 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
173 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline and 9 monthsPopulation: The efficacy population was the intent-to-treat (ITT). This included all randomized subjects who had a baseline primary efficacy evaluation, had taken at least 1 dose of test article, and had at least 1 primary efficacy evaluation (ie, at least 1 NRS daily pain score) after the first dose of test article. No participants met that criterion.
The primary efficacy variable was the pain severity score measured on an 11 point NRS on which 0=no pain and 10=worst possible pain. The primary efficacy evaluation was the change from baseline in mean pain score on the NRS.
Outcome measures
Outcome data not reported
Adverse Events
DVS SR Open Label
Serious events: 26 serious events
Other events: 199 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DVS SR Open Label
n=237 participants at risk
Daily dose of 100mg or 200mg at the investigators discretion. Subjects already randomized at a dose of 400mg may continue at that dose level.
|
|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.42%
1/237
|
|
Cardiac disorders
Angina pectoris
|
0.42%
1/237
|
|
Cardiac disorders
Atrial fibrillation
|
0.42%
1/237
|
|
Cardiac disorders
Bradycardia
|
0.42%
1/237
|
|
Cardiac disorders
Cardiac failure congestive
|
1.3%
3/237
|
|
Cardiac disorders
Diastolic dysfunction
|
0.42%
1/237
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.42%
1/237
|
|
Gastrointestinal disorders
Diarrhoea
|
0.42%
1/237
|
|
Gastrointestinal disorders
Erosive oesophagitis
|
0.42%
1/237
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.42%
1/237
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.84%
2/237
|
|
Gastrointestinal disorders
Nausea
|
1.3%
3/237
|
|
Gastrointestinal disorders
Vomiting
|
0.84%
2/237
|
|
General disorders
Asthenia
|
0.42%
1/237
|
|
General disorders
Chest pain
|
1.3%
3/237
|
|
General disorders
Oedema peripheral
|
0.42%
1/237
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.42%
1/237
|
|
Infections and infestations
Cellulitis
|
0.42%
1/237
|
|
Infections and infestations
Diverticulitis
|
0.42%
1/237
|
|
Infections and infestations
Localised infection
|
0.84%
2/237
|
|
Infections and infestations
Pneumonia
|
0.42%
1/237
|
|
Injury, poisoning and procedural complications
Overdose
|
0.42%
1/237
|
|
Investigations
Blood glucose fluctuation
|
0.42%
1/237
|
|
Investigations
Blood glucose increased
|
0.42%
1/237
|
|
Investigations
Blood pressure increased
|
0.42%
1/237
|
|
Metabolism and nutrition disorders
Dehydration
|
0.42%
1/237
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.42%
1/237
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.42%
1/237
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.42%
1/237
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.42%
1/237
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.42%
1/237
|
|
Nervous system disorders
Headache
|
0.84%
2/237
|
|
Nervous system disorders
Status epilepticus
|
0.42%
1/237
|
|
Nervous system disorders
Syncope
|
0.42%
1/237
|
|
Psychiatric disorders
Mental status changes
|
0.84%
2/237
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.42%
1/237
|
|
Renal and urinary disorders
Renal failure acute
|
0.42%
1/237
|
|
Renal and urinary disorders
Urinary retention
|
0.42%
1/237
|
|
Reproductive system and breast disorders
Ovarian mass
|
0.42%
1/237
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.42%
1/237
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.42%
1/237
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.42%
1/237
|
|
Vascular disorders
Iliac artery stenosis
|
0.42%
1/237
|
Other adverse events
| Measure |
DVS SR Open Label
n=237 participants at risk
Daily dose of 100mg or 200mg at the investigators discretion. Subjects already randomized at a dose of 400mg may continue at that dose level.
|
|---|---|
|
Ear and labyrinth disorders
Ear and labyrinth disorders general
|
5.1%
12/237
|
|
Eye disorders
Eye disorders general
|
5.5%
13/237
|
|
Gastrointestinal disorders
Diarrhoea
|
5.1%
12/237
|
|
Gastrointestinal disorders
Dry mouth
|
6.3%
15/237
|
|
Gastrointestinal disorders
Nausea
|
9.7%
23/237
|
|
Gastrointestinal disorders
Vomiting
|
6.8%
16/237
|
|
General disorders
Fatigue
|
5.5%
13/237
|
|
Infections and infestations
Nasopharyngitis
|
8.0%
19/237
|
|
Infections and infestations
Upper respiratory tract infection
|
10.1%
24/237
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications general
|
19.4%
46/237
|
|
Investigations
Investigations general
|
16.0%
38/237
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders general
|
8.4%
20/237
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.9%
14/237
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.1%
12/237
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.5%
13/237
|
|
Nervous system disorders
Dizziness
|
16.5%
39/237
|
|
Nervous system disorders
Headache
|
7.6%
18/237
|
|
Psychiatric disorders
Psychiatric disorders general
|
14.8%
35/237
|
|
Renal and urinary disorders
Renal and urinary disorders general
|
11.8%
28/237
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders general
|
5.5%
13/237
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders general
|
11.0%
26/237
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders general
|
15.6%
37/237
|
|
Vascular disorders
Hypertension
|
8.0%
19/237
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The PIs agreed to allow the sponsor 60 days to review and require changes to presentations or publications but only to protect confidential information and intellectual property, and for the sponsor to file a patent application, as applicable. The PIs also agreed for data to be presented first as a joint, multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER