Trial Outcomes & Findings for A Study Evaluating Desvenlafaxine Sustained Release (DVS SR) in Adult Female Outpatients With Fibromyalgia (NCT NCT00696787)

Last Updated: 2013-02-25

Results Overview

The primary efficacy variable was the change from baseline on the NRS. The primary time point was the average pain score during the last data-analysis-interval of week 8. The baseline score was the average of the NRS scores across the last 7 days of the screening period (just prior to the start of the placebo run-in). 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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

125 participants

Primary outcome timeframe

Baseline and 8 weeks

Results posted on

2013-02-25

Participant Flow

Subjects were recruited in the United States from June 2006 to November 2008.

After a 7 to 30 day screening period, eligible subjects entered a 7 day single blind placebo run-in period during which placebo responses were assessed.

Participant milestones

Participant milestones
Measure	Placebo In the first stage, subjects were randomly assigned to receive placebo. Study was stopped after stage 1 by sponsor.	DVS SR In the first stage, subjects were randomly assigned to receive DVS SR 200 mg/day. Study was stopped after stage 1 by sponsor.	Pregabalin In the first stage, subjects were randomly assigned to receive Pregabalin 450 mg/day. Study was stopped after stage 1 by sponsor.
Overall Study STARTED	40	42	43
Overall Study COMPLETED	25	22	17
Overall Study NOT COMPLETED	15	20	26

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo In the first stage, subjects were randomly assigned to receive placebo. Study was stopped after stage 1 by sponsor.	DVS SR In the first stage, subjects were randomly assigned to receive DVS SR 200 mg/day. Study was stopped after stage 1 by sponsor.	Pregabalin In the first stage, subjects were randomly assigned to receive Pregabalin 450 mg/day. Study was stopped after stage 1 by sponsor.
Overall Study Adverse Event	1	0	6
Overall Study Discontinuation by Sponsor	9	13	14
Overall Study Lack of Efficacy	0	1	0
Overall Study Lost to Follow-up	4	0	3
Overall Study Withdrawal by Subject	0	3	2
Overall Study Failed to return	1	3	1

Baseline Characteristics

A Study Evaluating Desvenlafaxine Sustained Release (DVS SR) in Adult Female Outpatients With Fibromyalgia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=40 Participants In the first stage, subjects were randomly assigned to receive placebo. Study was stopped after stage 1 by sponsor.	DVS SR n=42 Participants In the first stage, subjects were randomly assigned to receive DVS SR 200 mg/day. Study was stopped after stage 1 by sponsor.	Pregabalin n=43 Participants In the first stage, subjects were randomly assigned to receive Pregabalin 450 mg/day. Study was stopped after stage 1 by sponsor.	Total n=125 Participants Total of all reporting groups
Age Continuous	46.90 years STANDARD_DEVIATION 12.65 • n=5 Participants	47.83 years STANDARD_DEVIATION 10.53 • n=7 Participants	45.42 years STANDARD_DEVIATION 12.11 • n=5 Participants	46.70 years STANDARD_DEVIATION 11.74 • n=4 Participants
Sex: Female, Male Female	40 Participants n=5 Participants	42 Participants n=7 Participants	43 Participants n=5 Participants	125 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline and 8 weeks

Population: The Modified Intent to Treat (MITT) population included all randomized subjects who had taken at least one dose of double-blind test article, who had a baseline primary efficacy evaluation, and who had at least one primary efficacy evaluation on double-blind therapy.

Outcome measures

Outcome measures
Measure	Placebo n=40 Participants In the first stage, subjects were randomly assigned to receive placebo. Study was stopped after stage 1 by sponsor.	DVS SR n=42 Participants In the first stage, subjects were randomly assigned to receive DVS SR 200 mg/day. Study was stopped after stage 1 by sponsor.	Pregabalin n=43 Participants In the first stage, subjects were randomly assigned to receive Pregabalin 450 mg/day. Study was stopped after stage 1 by sponsor.
Change From Baseline on the Numeric Rating Scale (NRS)	-1.98 units on scale Standard Error 0.37	-1.60 units on scale Standard Error 0.37	-1.70 units on scale Standard Error 0.38

SECONDARY outcome

Timeframe: Baseline and 8 weeks

Population: All randomized subjects who had taken at least one dose of double-blind test article, had a baseline primary efficacy evaluation, and had at least one primary efficacy evaluation on double-blind therapy. Subjects who did not complete the study due to its discontinuation were excluded.

The efficacy variable was the change from baseline on the numeric rating scale (NRS). The time point was the average pain score during the last data-analysis-interval of week 8, data analysis interval. The baseline score was the average of the NRS scores across the last 7 days of the screening period (just prior to the start of the placebo run-in). The efficacy variable was the pain severity score measured on an 11 point NRS on which 0=no pain and 10=worst possible pain.

Outcome measures

Outcome measures
Measure	Placebo n=31 Participants In the first stage, subjects were randomly assigned to receive placebo. Study was stopped after stage 1 by sponsor.	DVS SR n=29 Participants In the first stage, subjects were randomly assigned to receive DVS SR 200 mg/day. Study was stopped after stage 1 by sponsor.	Pregabalin n=29 Participants In the first stage, subjects were randomly assigned to receive Pregabalin 450 mg/day. Study was stopped after stage 1 by sponsor.
Change From Baseline on the Numeric Rating Scale (NRS) in the Treatment of Pain Associated With Fibromyalgia in Adult Female Outpatients	-2.00 units on scale Standard Error 0.37	-1.64 units on scale Standard Error 0.39	-1.45 units on scale Standard Error 0.40

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 25 other events

Deaths: 0 deaths

DVS SR

Serious events: 0 serious events

Other events: 25 other events

Deaths: 0 deaths

Pregabalin

Serious events: 1 serious events

Other events: 32 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=40 participants at risk In the first stage, subjects were randomly assigned to receive placebo. Study was stopped after stage 1 by sponsor.	DVS SR n=42 participants at risk In the first stage, subjects were randomly assigned to receive DVS SR 200 mg/day. Study was stopped after stage 1 by sponsor.	Pregabalin n=43 participants at risk In the first stage, subjects were randomly assigned to receive Pregabalin 450 mg/day. Study was stopped after stage 1 by sponsor.
Reproductive system and breast disorders Pregnancy and spontaneous abortion	0.00% 0/40	0.00% 0/42	2.3% 1/43

Other adverse events

Other adverse events
Measure	Placebo n=40 participants at risk In the first stage, subjects were randomly assigned to receive placebo. Study was stopped after stage 1 by sponsor.	DVS SR n=42 participants at risk In the first stage, subjects were randomly assigned to receive DVS SR 200 mg/day. Study was stopped after stage 1 by sponsor.	Pregabalin n=43 participants at risk In the first stage, subjects were randomly assigned to receive Pregabalin 450 mg/day. Study was stopped after stage 1 by sponsor.
Eye disorders Eye disorders general	2.5% 1/40	0.00% 0/42	7.0% 3/43
Gastrointestinal disorders Constipation	2.5% 1/40	11.9% 5/42	2.3% 1/43
Gastrointestinal disorders Diarrhoea	5.0% 2/40	2.4% 1/42	2.3% 1/43
Gastrointestinal disorders Dry mouth	5.0% 2/40	4.8% 2/42	4.7% 2/43
Gastrointestinal disorders Nausea	10.0% 4/40	14.3% 6/42	7.0% 3/43
Gastrointestinal disorders Vomiting	7.5% 3/40	4.8% 2/42	0.00% 0/43
General disorders Fatigue	0.00% 0/40	2.4% 1/42	7.0% 3/43
Infections and infestations Upper respiratory tract infection	5.0% 2/40	2.4% 1/42	11.6% 5/43
Injury, poisoning and procedural complications Injury, poisoning and procedural complications general	5.0% 2/40	2.4% 1/42	7.0% 3/43
Metabolism and nutrition disorders Metabolism and nutrition disorders general	2.5% 1/40	4.8% 2/42	7.0% 3/43
Musculoskeletal and connective tissue disorders Arthralgia	5.0% 2/40	2.4% 1/42	0.00% 0/43
Musculoskeletal and connective tissue disorders Myalgia	5.0% 2/40	0.00% 0/42	0.00% 0/43
Nervous system disorders Dizziness	2.5% 1/40	4.8% 2/42	37.2% 16/43
Nervous system disorders Headache	10.0% 4/40	4.8% 2/42	11.6% 5/43
Nervous system disorders Migraine	5.0% 2/40	0.00% 0/42	2.3% 1/43
Nervous system disorders Somnolence	10.0% 4/40	4.8% 2/42	14.0% 6/43
Psychiatric disorders Insomnia	10.0% 4/40	2.4% 1/42	0.00% 0/43
Reproductive system and breast disorders Reproductive system and breast disorders general	5.0% 2/40	0.00% 0/42	0.00% 0/43
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders general	7.5% 3/40	4.8% 2/42	2.3% 1/43
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders general	0.00% 0/40	11.9% 5/42	7.0% 3/43

Additional Information

U. S. Contact Center

Wyeth

Email: [email protected]

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