An Extension Study of Duloxetine in Fibromyalgia (Extension of F1J-JE-HMGZ, NCT01552057)

Browse trials for

• Fibromyalgia 1,336
• Myofascial Pain Syndromes 1,136

Fibromyalgia

1,336 studies on the registry are indexed under Fibromyalgia; 266 are open to participants now.

This study's enrollment of 149 is above the median of 60 across 1,035 interventional studies indexed under Fibromyalgia.

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Study arms

• Experimental
  60 mg Duloxetine

  Duloxetine 20 milligrams (mg) taken orally once every day for 1 week, followed by 40 mg taken orally once every day for 1 week, and then 60 mg taken orally once every day for 48 weeks

  Drug: Duloxetine

Interventions

• DrugDuloxetine

  Administered Orally

  Also known as: LY248686, Cymbalta, Ariclaim, Xeristar, Yentreve

Primary outcomes

1. Number of Participants Who Experienced an Adverse Event (AE)

   A summary of serious and other non-serious AEs regardless of causality is located in the Reported Adverse Events module.

   Time frame: Baseline through 53 weeks

Secondary outcomes

1. Patient Global Impression-Improvement (PGI-I) at Endpoint

   PGI-I measures the participant's perception of improvement at the time of assessment compared with the start of treatment. Scores ranged from 1 (very much better) to 7 (very much worse).

   Time frame: 50 weeks

2. Clinical Global Impression-Improvement (CGI-I) at Endpoint

   CGI-I measures the clinician's perception of participant improvement at the time of assessment (compared with the start of treatment). Scores ranged from 1 (very much better) to 7 (very much worse).

   Time frame: 50 weeks

3. Change From Baseline to 50-Week Endpoint in Fibromyalgia Impact Questionnaire (FIQ)

   FIQ is a 20-item, self-administered questionnaire using Likert-type scales to measure participant outcomes over the past week. Items 1 through 11 measured physical functioning on 4-point scales. Items 12 and 13 measured the number of days a participant felt well and days a participant was unable to work due to fibromyalgia symptoms, respectively. Items 14 through 20 were 11-point scales on which a participant rated work difficulty, pain, fatigue, morning tiredness, stiffness, anxiety, and depression, respectively. If a participant did not do all the tasks listed, those items were deleted from scoring. Algorithms were used to determine total FIQ scores which ranged from 0 to 100; higher scores indicated a more negative impact.

   Time frame: Baseline, 50 weeks

4. Change From Baseline to 50-Week Endpoint in Brief Pain Inventory-Severity (BPI-S) and Brief Pain Inventory-Interference (BPI-I) Scores on the BPI-Modified Short Form

   BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function, respectively. Severity scores ranged from 0 (no pain) to 10 (severe pain) for each question assessing average pain, worst pain, least pain, and pain right now. Interference scores ranged from 0 (does not interfere) to 10 (completely interferes) for each question assessing interference of pain in past 24 hours with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference was the average of non-missing scores of individual interference items.

   Time frame: Baseline, 50 weeks

5. Change From Baseline to 50-Week Endpoint in 36-Item Short-Form (SF-36) Health Survey Domain Scores

   The SF-36 Health Survey is a generic, health-related survey assessing the participant's quality of life on 8 domains: physical functioning, daily functioning (physical), bodily pain, general health, vitality, social functioning, daily functioning (emotional), and mental health. Each domain was scored by summing individual items pertaining to that domain and transforming scores into a 0 to 100 scale, with higher scores indicating better health status or functioning.

   Time frame: Baseline, 50 weeks

6. Change From Baseline to 50-Week Endpoint in Beck Depression Inventory-II (BDI-II)

   The BDI-II is a 21-item self-administered questionnaire designed to assess the characteristics of depression. Each item was scored on a 4-point scale ranging from 0 (not present) to 3 (present in the extreme) and was summed to give a total BDI-II score. A total BDI-II score of 0 through 13 was considered minimal, 14 through 19 was mild, 20 through 28 was moderate, and 29 through 63 was severe depression symptoms.

   Time frame: Baseline, 50 weeks

7. Change From Baseline to 50-Week Endpoint in Widespread Pain Index (WPI) and Symptom Severity (SS) in American College of Rheumatology (ACR) Fibromyalgia Diagnostic Criteria 2010

   WPI: Participant-reported areas (out of 19 points on the body) in which the participant had pain in the past week. WPI scores ranged from 0 (no areas) to 19 (all areas). SS: The sum of severity scores for fatigue, waking unrefreshed, and cognitive symptoms \[each rated from 0 (no problem) to 3 (severe; life-disturbing problems)\] plus the severity of somatic symptoms in general \[rated from 0 (no symptoms) to 3 (a great deal of symptoms)\]. The total SS score ranged from 0 and 12.

   Time frame: Baseline, 50 weeks

Baseline characteristics