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PainPhase 3NCT02462850

A Multi-Center Actual-Use Study on the Safety of CL 108 for the Treatment of Moderate to Severe Acute Pain Associated With Osteoarthritis of the Knee or Hip

A Phase 3 study testing CL-108 in people with Pain and Nausea, run by Charleston Laboratories, Inc 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 CLCT-006, a multi-center open-label study, is to evaluate the safety of CL-108 (hydrocodone 7.5 mg/APAP 325 mg, promethazine 12.5 mg) for the treatment of moderate to severe acute pain ("flare") associated with osteoarthritis of the knee or hip under actual conditions of use. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pain, Nausea, Vomiting
What is being tested?
CL-108
Could I receive a placebo?
No, everyone receives an active treatment
How many people
178 participants
Where
1 siteUnited States
Study dates
Oct 2014to Feb 2015
Phase
Phase 3
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Informed consent
  • Signed consent obtained at screening prior to any procedures being performed.
  • Gender
  • Male or non-pregnant and non-lactating female. A female of child-bearing potential is eligible to participate in this study if she has a negative urine pregnancy test and is post-menopausal or using an acceptable method of birth control (i.e., hormonal, transdermal, or implanted contraceptives, intra-uterine device, diaphragm, condom, abstinence, or surgical sterilization)
  • Age
  • At least 18 years of age
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  • Diagnosis of OA
  • Clinical diagnosis of osteoarthritis of the hip and/or knee (signal joints) based on history and physical findings
  • Confirmation of OA
  • Radiographic evidence of OA of the knee or hip (e.g., joint space narrowing, K-L grades 1-4). [Any X-ray finding or report of an X-ray finding at any time that is indicative of OA of the knee or hip confirms the diagnosis of OA.]
  • Treatment of OA
  • Inadequate or unsatisfactory treatment with an NSAID for OA of the knee or hip with no previous use of an opioid for OA (i.e., need for "step up" to opioid treatment).
  • Flare of OA
  • Complaint of acute pain in the knee or hip (i.e., "flare" of osteoarthritis of the knee or hip)
  • Duration of Acute Pain
  • Pain in the signal joint(s) with onset ≤ 14 days
  • Pain Severity
  • Baseline PIS score must be ≥ moderate
  • Alcohol Intake
  • Willing to limit alcohol intake to ≤ 2 drinks per day during the study (i.e., from Screening Visit 1 through Follow-Up Visit 3)
  • Diary Completion
  • Be willing and able to record effectiveness, tolerability, and drug utilization information in the In-Clinic and Outpatient Diaries.

Who cannot join

  • Medical Condition
  • Presence of a serious uncontrolled medical condition (e.g., poorly controlled hypertension or diabetes)
  • Confounding Diseases
  • Presence of other major joint or bone disease (e.g., gout, inflammatory arthritis, Paget's disease), chronic pain syndrome, or fibromyalgia
  • Surgery
  • Patients who have had surgery on the affected joint within the past 6 months, subjects with a prosthesis at the index joint, patients possibly requiring knee or hip arthroplasty or other surgical procedure on the index joint within 3 months following screening
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  • Drug Allergy
  • History of hypersensitivity to an opioid drug, promethazine, acetaminophen, or NSAID (such as ibuprofen) or history of a dystonic/dyskinetic reaction to prior antiemetic or anti-psychotic medication
  • Confounding and Contraindicated Drugs
  • Use within 24 hours of Visit 2 of any analgesic (in particular, opioid), anti-emetic, glucosamine, chondroitin sulfate, or any drug contraindicated with hydrocodone, acetaminophen, or promethazine. Use within 4 months of Visit 2 of any intra-articular or oral corticosteroid or hyaluronic acid.
  • Investigational Drug Use
  • Use of any investigational drug within the past 30 days
  • Participated in Study
  • Previous participation in this study
  • Pregnancy, Lactation
  • Women who are pregnant or breast-feeding
  • Participant Relationship
  • Employee of the Principal Investigator, Sub-investigators or Charleston Laboratories or relative of an employee who is directly involved in this study.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: A Phase 3 Multi-Center Actual-Use Study on the Safety of CL 108 for the Treatment of Moderate to Severe Acute Pain Associated With Osteoarthritis of the Knee or Hip

The purpose of CLCT-006, a multi-center open-label study, is to evaluate the safety of CL-108 (hydrocodone 7.5 mg/APAP 325 mg, promethazine 12.5 mg) for the treatment of moderate to severe acute pain ("flare") associated with osteoarthritis of the knee or hip under actual conditions of use.

Read the detailed description

The purpose of CLCT-006, a multi-center open-label study, is to evaluate the safety of CL-108 (hydrocodone 7.5 mg/APAP 325 mg, promethazine 12.5 mg) for the treatment of moderate to severe acute pain ("flare") associated with osteoarthritis of the knee or hip under actual conditions of use.

The study will also endeavor to determine

  • the physicians' global evaluation of CL-108 as a treatment for moderate to severe acute pain associated with osteoarthritis of the knee or hip
  • the patients' global impression of change in pain after treatment of moderate to severe acute pain associated with osteoarthritis of the knee or hip
  • any change in the patient's quality of life after treatment of moderate to severe acute pain associated with osteoarthritis of the knee or hip
  • the percentage change in pain intensity after treatment of moderate to severe acute pain associated with osteoarthritis of the knee or hip
Conditions
Pain, Nausea, Vomiting
Being tested
CL-108
Keywords
Pain, Nausea, Vomiting
Medical subject headings
Pain, Nausea, Vomiting

What participants receive

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

  • CL-108Drug

Study groups in NCT02462850
Study groupRoleWhat they receive
CL-108ExperimentalCL-108 Hydrocodone 7.5 mg, acetaminophen 325 mg, Promethazine 12.5 mg
Receives: Drug: CL-108

What is being measured

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

  1. The safety of CL-108 will be evaluated and assessed by questionnaire, when used, for the treatment of moderate to severe acute pain associated with osteoarthritis of the knee or hip.

    Measured: 24 hours

Secondary outcomes (3)

  1. An assessment of the study medication will be provided as a treatment for osteoarthritis on the Physician's Global Evaluation (PGE) utilizing a poor to excellent scale

    Measured: 24 hours

  2. The change in arthritic pain since taking study medication over a specific period will be assessed on the Patient Global Impression of Change scale (PGIC)

    Measured: 24 hours

  3. Patients will complete a standard QOL questionnaire, comprising five dimensions of health-related quality of life (mobility, self-care, usual activities, pain/discomfort, and anxiety/ depression).

    Measured: 24 hours

Timeline

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

  1. First posted4 Jun 2015 (estimated)
  2. Study startOct 2014
  3. Primary completionJan 2015
  4. Study completionFeb 2015

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 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
178 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02462850
Sponsor's protocol ID
CLCT-006
Status last verified
Feb 2016
First submitted
22 May 2015
Last updated
3 Nov 2016
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CL-108 in people with Pain and Nausea, run by Charleston Laboratories, Inc 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 22 inclusion and 18 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 3 Nov 2016. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 safety of CL-108 will be evaluated and assessed by questionnaire, when used, for the treatment of moderate to severe acute pain associated with osteoarthritis of the knee or hip. (time frame: 24 hours). 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 NCT02462850.

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 3 Nov 2016.

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