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Chronic Shoulder PainPhase 4NCT01289236

"MILNACIPRAN" in Subjects With Chronic Shoulder Pain

A Phase 4 study testing milnacipran in people with Chronic Shoulder Pain, run by Valera Bussell at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to compare the safety and efficacy of multiple doses of "Milnacipran" to a placebo dose in subjects with Chronic Shoulder Pain. Read more about this study

Who is it for?
Ages 25 years and older
Conditions the study is for
Chronic Shoulder Pain
What is being tested?
milnacipran
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteUnited States
Study dates
Oct 2009to Jun 2011
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males, postmenopausal/ sterile females or females using reliable contraceptives who are >25 years of age.
  • Chronic shoulder pain in at least one shoulder for > 3 months (If both shoulders are painful, the investigator will choose the most painful shoulder for evaluation during the study) If both are equally painful, the investigator will choose the shoulder for evaluation.
  • History of shoulder or proximal arm pain due to bursitis, osteoarthritis of the shoulder, impingement or rotator cuff tear.
  • Subjects who give their written informed consent.
  • Subjects who at screening are not on chronic analgesic/anti-inflammatory medication and have a VAS pain score of > 40mm and < 90mm or subjects who are on chronic analgesic/anti-inflammatory medication at screening and have a VAS pain score of > 30mm and < 90mm, indicating a lack of adequate and sustained response to current therapy.
  • At baseline, after all analgesic/anti-inflammatory medication has been discontinued for 2 weeks (including withdrawal from acetaminophen rescue medication for 24 hours prior to screening) should have a VAS pain score of > 40mm and < 90mm.
  • Subjects who are willing to discontinue all NSAIDs or other analgesic medication taken for their shoulder pain with the exception of acetaminophen 500-1000mg (1-2 tablets) q.i.d., p.r.n. (maximum 8 tablets or 4 grams per day. Subjects must be willing to use only acetaminophen as a rescue pain medication for the shoulder pain. All analgesic medications must be stopped at least 2 weeks prior to the baseline visit and all acetaminophen must be discontinued at least 24 hours prior to the baseline visit. Subjects must be willing to abstain from any peri-articular injections for the shoulder during the course of the trial.
  • Subjects who have an x-ray at screening or MRI within 6 months prior to screening.

Who cannot join

  • Women of childbearing potential may not be entered if:
  • Their pregnancy tests (urine) are positive They are nursing They do not use or agree to use an effective method of contraception until all follow-up procedures are complete. (Acceptable methods of contraception are oral, injectable, implanted contraceptive agent, abstinence or an intra-uterine device with a failure rate of < 1%
  • Participation in another experimental drug/device study within the past 30 days.
  • Acute infection of the study joint
  • History of adverse reaction or allergy to milnacipran or acetaminophen
  • Shoulder pain due to an injury for which litigation is planned or pending.
Show all 29Show fewer
  • Any cervical spine disease that in the opinion of the investigator could confound assessments during the study.
  • Use of any oral corticosteroid during the past 30 days or peri-articular corticosteroid injection during the past 1 month.
  • Subjects with shoulder x-ray findings of fractures or avascular necrosis.
  • Subjects with any inter-current disease or condition that may interfere with the free use or evaluation of the affected shoulder for the duration of their participation in the study (severe congenital defects, weight bearing use of the shoulder due to crutches, walkers, canes etc.)
  • Subjects with history of alcohol or drug abuse within the past 5 years.
  • Subjects who have a compromised mental capacity or who may be unable to legally comprehend the details and nature of the study.
  • In the opinion of the investigator, a clinically significant abnormal lab results or history of disease that may place the subject at a health risk or compromise the study data or affect the subject's ability to complete the study.
  • Subjects who in the opinion of the investigator are unlikely to adhere to the study protocol or to complete the study as planned.
  • Subject has a chronic pain condition (chronic low back pain, chronic headache, fibromyalgia, chronic osteoarthritis, chronic rheumatoid arthritis etc.) that could confound the shoulder pain response to the study medication(in the opinion of the investigator)
  • Subject is using and is not willing to discontinue opioids, topical counterirritants (eg methylsalicylate or capsaicin) or the use of orthopedic devices for the study shoulder.
  • Significant liver impairment (defined as liver enzymes elevated more than three times the upper limit of normal) or significant renal impairment (defined as a serum creatinine level greater than twice the upper limit of normal.
  • Uncontrolled hypertension, history of stroke or transient ischemic attack within 6 months of enrollment, epilepsy, history of malignant neoplastic disease that is active (basal cell carcinoma of the skin is permitted), active infectious disease.
  • Subjects who have a history of uncontrolled Narrow Angle Glaucoma
  • Subjects who test positive for illegal or prohibited substances at Screening as demonstrated by a positive urine test or based on the Investigator's judgment.
  • Subjects who have active peptic ulcer disease, a history of inflammatory bowel disease or celiac sprue.
  • Subjects who have pulmonary dysfunction or severe chronic obstructive pulmonary disease that in the Investigator's opinion could interfere with study participation and completion.
  • Subjects who have unstable endocrine disease, including unstable diabetes or thyroid disease. Subjects with endocrine disorders that have been stable for the preceding 3 months will be permitted to enroll.
  • Male subjects with prostatic enlargement or other genitourinary disorders that put them at potentially significant risk for dysuria and/or urinary retention while taking agents with noradrenaline-reuptake inhibition properties (Entry permitted at Investigator's discretion)
  • Subjects who must participate in Physical Therapy during the course of their participation, unless stable in the opinion of the investigator.
  • Subjects with shoulder pain or other referred pain that does not originate from the shoulder.
  • Subjects who are taking SNRIs such as: Cymbalta
  • Subjects who are taking Lyrica or Neurontin
  • Subjects with cervical radiculopathy.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Delray Research Associates

    Delray Beach, Florida, 33484

Other trials in United States

About this study

Official title: An Exploratory, Randomized, Single Blinded, Placebo-Controlled, Dose-Ranging Study of the Safety and Efficacy of "MILNACIPRAN" in Subjects With Chronic Shoulder Pain

The purpose of this study is to compare the safety and efficacy of multiple doses of "Milnacipran" to a placebo dose in subjects with Chronic Shoulder Pain.

Read the detailed description

16 weeks. It is planned that this study will be conducted at a single site and will enroll approximately 40 subjects over 2-4 months. At the end of the 12-week dosing period, the study drug will be discontinued and all subjects in the treatment groups and control group will be followed for an additional 4 weeks.

Being tested
milnacipran, Placebo
Keywords
Shoulder Pain
Medical subject headings
Shoulder Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • milnacipranDrug

    Also called Savella

    1 tablet (50mg) BID (twice daily, approximately 12 hours apart) for 12 weeks after appropriate titration period

  • MilnacipranDrug

    Also called Savella

    1 tablet (100mg) BID (twice daily, approximately 12 hours apart)for 12 weeks after appropriate titration period.

  • PlaceboDrug

    1 tablet (placebo) BID (twice daily, approximately 12 hours apart) for 12 weeks after appropriate titration period.

Study groups in NCT01289236
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo BID (twice daily, approximately 12 hours apart)
Receives: Drug: Placebo
milnacipran 200 mgActive comparator200mg- 1 100mg tablet BID (twice daily, approximately 12 hours apart)
Receives: Drug: Milnacipran
milnacipran 100 mgActive comparator100mg- 1 50mg tablet BID (twice daily, approximately 12 hours apart)
Receives: Drug: milnacipran

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The primary efficacy endpoint will be the reduction in the mean VAS for chronic shoulder pain

    The primary efficacy endpoint will be the reduction in the mean VAS (Visual Analog Scale) for chronic shoulder pain at Week 12

    Measured: Week 12

Secondary outcomes (3)

  1. Improvement in the PGIC

    Overall improvement in the PGIC (Patient Global Impression of Change) at Week 12

    Measured: Week 12

  2. An improvement in the SPADI score

    Improvement in the SPADI (Shoulder Pain and Disability Index) score at Week 12

    Measured: Week 12

  3. Improvement in the SF-36 Health Questionnaire

    Improvement in the SF-36 (Short Form-36) Health Questionnaire at Week 12

    Measured: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2011 (estimated)
  2. Study startOct 2009
  3. Primary completionJun 2011
  4. Study completionJun 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01289236
Sponsor's protocol ID
SAV-MD-02
Status last verified
Aug 2012
First submitted
1 Feb 2011
Last updated
9 Aug 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing milnacipran in people with Chronic Shoulder Pain, run by Valera Bussell at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary efficacy endpoint will be the reduction in the mean VAS for chronic shoulder pain (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01289236.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2012.

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