Bone Pain in Stage I - III Breast CancerPhase 2NOLANNCT01712009

NOLAN: Naproxen or Loratadine and Neulasta

A Phase 2 study testing Naproxen, Loratadine and Pegfilgrastim in people with Bone Pain in Stage I - III Breast Cancer, run by Amgen at 83 sites 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 primary objective of the study is to estimate the difference in bone pain between breast cancer patients receiving chemotherapy and pegfilgrastim and either no prophylactic intervention, prophylactic naproxen, or prophylactic loratadine. Read more about this study

Who is it for?: Ages 18 to 100 years, women only
Conditions the study is for: Bone Pain in Stage I - III Breast Cancer
What is being tested?: Naproxen, Loratadine and Pegfilgrastim
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 600 participants
Where: 83 sitesUnited States
Study dates: 1 Nov 2012to 18 Mar 2015
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 100 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

None listed.

Who cannot join

History of other malignancy within the past 5 years, with the following exceptions:
Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
Adequately treated cervical carcinoma in situ without evidence of disease
Planning to receive weekly chemotherapy
Ongoing chronic pain, or other painful conditions requiring treatment (including immediate post-operative treatment of surgical or procedural-associated pain) as determined by the investigator
Chronic oral steroid use. Premedication related to the administration of chemotherapy, and use of anti-emetics is allowed, per usual clinical practice

Show all 18Show fewer

Chronic use of oral non-steroidal anti-inflammatory drug (NSAIDs) or oral antihistamines outside of those dictated by the randomization groups outlined in the protocol, with the following exception:
Chronic oral aspirin use for cardiovascular-related indications
Prior chemotherapy treatment for cancer within 5 years of current breast cancer diagnosis
Prior use of granulocyte colony stimulating factor (G-CSF)
History of clinically significant gastrointestinal (GI) bleeding, history of GI ulcers or active GI bleeding within 6 months prior to randomization
History of clinically significant bleeding disorders, thromboembolism within 6 months prior to randomization
Currently enrolled in, or less than 30 days since ending, another clinical trial which includes language directing G-CSF (filgrastim, pegfilgrastim, other) or granulocyte-macrophage colony-stimulating factor (GM-CSF) (sargramostim) use
Currently enrolled in, or less than 30 days since ending, another interventional clinical trial which includes a blinded treatment or blinded treatment arm (whether or not the subject is randomized to the blinded arm)
Currently enrolled in, or less than 30 days since ending, another interventional clinical trial which includes the use of any agent not currently considered to be standard therapy for the adjuvant or neoadjuvant treatment of stage I-III breast cancer based on National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for Breast Cancer
Currently enrolled in, or less than 30 days since ending, any pain intervention study
Female subjects who are pregnant or lactating or of reproductive potential not willing to employ an effective method of birth control during treatment and for 17 days after discontinuing study treatment
History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the Investigator or Amgen, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion

Trial locations and contacts

83 sites in 1 country.

City, postcode or hospital

83 sites in 1 country

United States83 sites

Research Site
Alexandria, Louisiana, 71301
Research Site
Anaheim, California, 92801
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Augusta, Georgia, 30901
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Battle Creek, Michigan, 49017
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Bend, Oregon, 97701
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Bethlehem, Pennsylvania, 18015
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Billings, Montana, 59101
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Boynton Beach, Florida, 33426
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Bristol, Tennessee, 37620
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Chattanooga, Tennessee, 37421
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Chesapeake, Virginia, 23320
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Corpus Christi, Texas, 78404
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Corpus Christi, Texas, 78412
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Cumberland, Maryland, 21502
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Daytona Beach, Florida, 32114
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Daytona Beach, Florida, 32117
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Denver, Colorado, 80210
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Denville, New Jersey, 07834
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Duluth, Minnesota, 55805
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East Syracuse, New York, 13057
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Elmhurst, Illinois, 60126
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Florence, South Carolina, 29506
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Fort Lauderdale, Florida, 33308
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Fullerton, California, 92835
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Gastonia, North Carolina, 28054
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Golden, Colorado, 80401
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Gurnee, Illinois, 60031
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Hickory, North Carolina, 28602
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Huntington, West Virginia, 25701
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Hutchinson, Kansas, 67502
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Indianapolis, Indiana, 46237
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Jackson, Mississippi, 39202
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Janesville, Wisconsin, 53548
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Jefferson City, Missouri, 65101
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Johnson City, New York, 13790
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Kansas City, Missouri, 64132
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Lafayette, Louisiana, 70503
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Lakeland, Florida, 33805
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Langhorne, Pennsylvania, 19047
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Lexington, Kentucky, 40503
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Littleton, Colorado, 80122
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Louisville, Kentucky, 40202
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Lowell, Massachusetts, 01854
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Madison, Wisconsin, 53792
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Marrero, Louisiana, 70072
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Massillon, Ohio, 44646
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Mount Sterling, Kentucky, 40353
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Mount Vernon, Illinois, 62864
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Muscle Shoals, Alabama, 35661
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Nashua, New Hampshire, 03060
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New Port Richey, Florida, 34652
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Norwich, Connecticut, 06360
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Ogden, Utah, 84403
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Omaha, Nebraska, 68106
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Paducah, Kentucky, 42003
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Pinehurst, North Carolina, 28374
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Plano, Texas, 75093
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Plantation, Florida, 33324
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Racine, Wisconsin, 53405
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Randallstown, Maryland, 21133
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Rockville, Maryland, 20850
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Saint Cloud, Minnesota, 56303
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Saint Joseph, Missouri, 64507
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Santa Maria, California, 93454
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Santa Rosa, California, 95403
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Shreveport, Louisiana, 71103
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Sioux City, Iowa, 51101
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Skokie, Illinois, 60076
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South Bend, Indiana, 46601
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Spokane, Washington, 99208
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St Louis, Missouri, 63136
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Stamford, Connecticut, 06902
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Stuart, Florida, 34994
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Thomasville, Georgia, 31792
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Torrance, California, 90501
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Urbana, Illinois, 61801
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Waterloo, Iowa, 50702
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Watertown, South Dakota, 57201
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Wauwatosa, Wisconsin, 53226
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Westminster, Maryland, 21157
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Weston, Wisconsin, 54476
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Whittier, California, 90603
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Zanesville, Ohio, 43701

Other trials in United States

About this study

Official title: Randomized, Phase 2 Study to Estimate the Effect of Prophylactic Intervention With Naproxen or Loratadine on Bone Pain in Breast Cancer Subjects Receiving Chemotherapy and Pegfilgrastim

Read the detailed description

In this study, the investigational products are naproxen, a non-steroidal antiinflammatory drug (NSAID), and loratadine, an anti-histamine. Both agents are being investigated as prophylactic medications to reduce the incidence and/or severity of bone pain in breast cancer patients receiving adjuvant or neoadjuvant myelosuppressive chemotherapy and pegfilgrastim prophylaxis.

Pegfilgrastim treatment is used to stimulate bone marrow to produce more neutrophils to help fight infections in patients undergoing chemotherapy.

Conditions: Bone Pain in Stage I - III Breast Cancer
Being tested: Naproxen, Loratadine, Pegfilgrastim, Chemotherapy
Keywords: Breast cancer, Chemotherapy, Neulasta, Pegfilgrastim, Naproxen, Loratadine, Non-steroidal antiinflammatory drug (NSAID), Anti-histamine, Bone Pain
Medical subject headings: Breast Neoplasms

What participants receive

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

NaproxenDrug
LoratadineDrug
PegfilgrastimBiological
Also called Neulasta®
Commercially available pegfilgrastim (Neulasta®) will be used in the study, and is considered background therapy. Pegfilgrastim is administered as a single 6 mg subcutaneous injection 24 hours to 72 hours after completion of chemotherapy.
ChemotherapyDrug
The choice of chemotherapy regimen (agent, dose, and schedule) is at the discretion of the treating physician.

Study groups in NCT01712009
Study group	Role	What they receive
Prophylactic naproxen	Experimental	Participants received adjuvant or neoadjuvant chemotherapy with pegfilgrastim prophylaxis in addition to prophylactic naproxen 500 mg orally twice a day (BID) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration. Receives: Drug: Naproxen; Biological: Pegfilgrastim; Drug: Chemotherapy
Prophylactic loratadine	Experimental	Participants received adjuvant or neoadjuvant chemotherapy with pegfilgrastim prophylaxis in addition to prophylactic loratadine 10 mg once a day (QD) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration. Receives: Drug: Loratadine; Biological: Pegfilgrastim; Drug: Chemotherapy
No prophylactic treatment	Other	Participants received adjuvant or neoadjuvant chemotherapy with pegfilgrastim prophylaxis. Receives: Biological: Pegfilgrastim; Drug: Chemotherapy

What is being measured

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

Percentage of Participants With Bone Pain (All Grades) in Cycle 1
Bone pain data were captured as part of standard adverse event (AE) reporting.
Measured: Cycle 1 (approximately 4 weeks, depending on the chemotherapy dosing interval)

Secondary outcomes (6)

Percentage of Participants With Bone Pain (All Grades) by Cycle (2-4) and Across Cycles
Bone pain data were captured as part of standard adverse event (AE) reporting.
Measured: Cycles 1, 2, 3 and 4 (approximately 4 weeks each, depending on the chemotherapy dosing interval)
Percentage of Participants With Severe Bone Pain by Cycle and Across Cycles
Bone pain data were captured as part of standard adverse event reporting. Severe bone pain is defined as grade 3 or 4 according to common terminology criteria for adverse events (CTCAE) version 3 grading criteria: Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, and Grade 4 = Life-threatening or disabling.
Measured: Cycles 1, 2, 3 and 4 (approximately 4 weeks each, depending on the chemotherapy dosing interval)
Mean Patient-reported Bone Pain by Cycle and Across Cycles
Participants completed a brief bone pain survey once per day for 5 days beginning the day they received their pegfilgrastim injection. The bone pain survey collected the severity of pain using a 0 (no pain) to 10 (worst pain) scale. Mean patient-reported bone pain values are the average of each participant's bone pain values across survey days 1-5 within each cycle. Across all cycles the mean is the average of each patient-reported bone pain value across all survey days 1-5 and across all cycles. An analysis of variance (ANOVA) model with treatment as explanatory term was used.
Measured: Five consecutive days during each cycle beginning on the day of pegfilgrastim administration (Day 2, 3, or 4 of each cycle)
Maximum Patient-reported Bone Pain by Cycle and Across Cycles
Participants completed a brief bone pain survey once per day for 5 days beginning the day they received their pegfilgrastim injection. The bone pain survey collected the severity of pain using a 0 (no pain) to 10 (worst pain) scale. Maximum patient-reported bone pain is the maximum of each participant's bone pain values across survey Days 1-5 within each cycle. Across all cycles the maximum is the maximum of each patient-reported bone pain value across all survey days 1-5 and across all cycles. An ANOVA model with treatment as explanatory term was used.
Measured: Five consecutive days during each cycle beginning on the day of pegfilgrastim administration (Day 2, 3, or 4 of each cycle)
Area Under the Curve (AUC) for Patient-reported Bone Pain
Patient-reported bone pain AUC was calculated using the trapezoidal rule with bone pain scores from day 1 to 5 for each cycle. The AUC across cycles is the average of AUCs across the cycle.
Measured: Five consecutive days during each cycle beginning on the day of pegfilgrastim administration (Day 2, 3, or 4 of each cycle)
Number of Participants With Adverse Events (AEs)
Severity was graded using CTCAE version 3. A serious adverse event (SAE) is defined as an adverse event that meets at least 1 of the following serious criteria: • fatal; • life threatening; • requires in-patient hospitalization or prolongation of existing hospitalization; • results in persistent or significant disability/incapacity; • congenital anomaly/birth defect; • other medically important serious event.
The investigator assessed each adverse event for relatedness to investigational product(s) or other protocol-required therapies.
Measured: From first dose of investigational product (IP, naproxen or loratidine) or first dose of pegfilgrastim (Peg), whichever occurred first, until 30 days after last dose, up to 24 weeks.

Timeline

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

1 Nov 201218 Mar 2015

First posted23 Oct 2012 (estimated)
Study start1 Nov 2012
Primary completion18 Mar 2015
Study completion18 Mar 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Bone Pain in Stage I - III Breast CancerStudies of the same condition, open and under way.
More trials run by AmgenThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 600 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01712009
Sponsor's protocol ID: 20110147
Acronym: NOLAN
Status last verified: Jan 2018
First submitted: 19 Oct 2012
Last updated: 30 Jan 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Kirshner JJ, McDonald MC 3rd, Kruter F, Guinigundo AS, Vanni L, Maxwell CL, Reiner M, Upchurch TE, Garcia J, Morrow PK. NOLAN: a randomized, phase 2 study to estimate the effect of prophylactic naproxen or loratadine vs no prophylactic treatment on bone pain in patients with early-stage breast cancer receiving chemotherapy and pegfilgrastim. Support Care Cancer. 2018 Apr;26(4):1323-1334. doi: 10.1007/s00520-017-3959-2. Epub 2017 Nov 16.
PubMed 29147854

Study at a glance

From the registry record, last updated by the sponsor on 30 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized, Phase 2 Study to Estimate the Effect of Prophylactic Intervention With Naproxen or Loratadine on Bone Pain in Breast Cancer Subjects Receiving Chemotherapy and Pegfilgrastim
ClinicalTrials.gov ID: NCT01712009
Acronym / sponsor ID: NOLAN / 20110147
Conditions: Bone Pain in Stage I - III Breast Cancer
Keywords: Breast cancer, Chemotherapy, Neulasta, Pegfilgrastim, Naproxen, Loratadine, Non-steroidal antiinflammatory drug (NSAID), Anti-histamine
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 600 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Study start: 1 Nov 2012 (actual)
Primary completion: 18 Mar 2015 (actual)
Study completion: 18 Mar 2015 (actual)
First posted: 23 Oct 2012 (estimated)
Results: Posted 9 Mar 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Pegfilgrastim treatment is used to stimulate bone marrow to produce more neutrophils to help fight infections in patients undergoing chemotherapy.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Prophylactic naproxen	Experimental	Drug: Naproxen, Biological: Pegfilgrastim, Drug: ChemotherapyParticipants received adjuvant or neoadjuvant chemotherapy with pegfilgrastim prophylaxis in addition to prophylactic naproxen 500 mg orally twice a day (BID) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
Prophylactic loratadine	Experimental	Drug: Loratadine, Biological: Pegfilgrastim, Drug: ChemotherapyParticipants received adjuvant or neoadjuvant chemotherapy with pegfilgrastim prophylaxis in addition to prophylactic loratadine 10 mg once a day (QD) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
No prophylactic treatment	Other	Biological: Pegfilgrastim, Drug: ChemotherapyParticipants received adjuvant or neoadjuvant chemotherapy with pegfilgrastim prophylaxis.

Who may qualify

Ages: 18 to 100 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (0 listed)

Key exclusion criteria (18 listed)

History of other malignancy within the past 5 years, with the following exceptions:
Planning to receive weekly chemotherapy
Ongoing chronic pain, or other painful conditions requiring treatment (including immediate post-operative treatment of surgical or procedural-associated pain) as determined by the investigator
Chronic oral steroid use. Premedication related to the administration of chemotherapy, and use of anti-emetics is allowed, per usual clinical practice
Chronic use of oral non-steroidal anti-inflammatory drug (NSAIDs) or oral antihistamines outside of those dictated by the randomization groups outlined in the protocol, with the following exception:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Naproxen	Drug	Prophylactic naproxen
Loratadine	Drug	Prophylactic loratadine
PegfilgrastimAlso: Neulasta®Commercially available pegfilgrastim (Neulasta®) will be used in the study, and is considered background therapy. Pegfilgrastim is administered as a single 6 mg subcutaneous injection 24 hours to 72 hours after completion of chemotherapy.	Biological	No prophylactic treatment, Prophylactic loratadine, Prophylactic naproxen
ChemotherapyThe choice of chemotherapy regimen (agent, dose, and schedule) is at the discretion of the treating physician.	Drug	No prophylactic treatment, Prophylactic loratadine, Prophylactic naproxen

Primary outcome

Percentage of Participants With Bone Pain (All Grades) in Cycle 1
Time frame: Cycle 1 (approximately 4 weeks, depending on the chemotherapy dosing interval)
Bone pain data were captured as part of standard adverse event (AE) reporting.

6 secondary outcomes

Percentage of Participants With Bone Pain (All Grades) by Cycle (2-4) and Across Cycles
Time frame: Cycles 1, 2, 3 and 4 (approximately 4 weeks each, depending on the chemotherapy dosing interval)
Percentage of Participants With Severe Bone Pain by Cycle and Across Cycles
Time frame: Cycles 1, 2, 3 and 4 (approximately 4 weeks each, depending on the chemotherapy dosing interval)
Mean Patient-reported Bone Pain by Cycle and Across Cycles
Time frame: Five consecutive days during each cycle beginning on the day of pegfilgrastim administration (Day 2, 3, or 4 of each cycle)
Maximum Patient-reported Bone Pain by Cycle and Across Cycles
Time frame: Five consecutive days during each cycle beginning on the day of pegfilgrastim administration (Day 2, 3, or 4 of each cycle)
Area Under the Curve (AUC) for Patient-reported Bone Pain
Time frame: Five consecutive days during each cycle beginning on the day of pegfilgrastim administration (Day 2, 3, or 4 of each cycle)
Number of Participants With Adverse Events (AEs)
Time frame: From first dose of investigational product (IP, naproxen or loratidine) or first dose of pegfilgrastim (Peg), whichever occurred first, until 30 days after last dose, up to 24 weeks.

Results and safety

Results posted to the registry on 9 Mar 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
No Prophylaxis	198	160
Naproxen 500 mg BID	200	171
Loratadine 10 mg QD	202	181

Primary outcome: Percentage of Participants With Bone Pain (All Grades) in Cycle 1

Time frame: Cycle 1 (approximately 4 weeks, depending on the chemotherapy dosing interval). Number (95% Confidence Interval). Unit: percentage of participants

Measure	No Prophylaxis n = 191	Naproxen 500 mg BID n = 196	Loratadine 10 mg QD n = 200
Value	46.6 (39.4 to 53.9)	40.3 (33.4 to 47.5)	42.5 (35.6 to 49.7)

No Prophylaxis vs Naproxen 500 mg BID: Difference: -6.3 (95% CI -16.7 to 4.1)
No Prophylaxis vs Loratadine 10 mg QD: Difference: -4.1 (95% CI -14.5 to 6.3)
Naproxen 500 mg BID vs Loratadine 10 mg QD: Difference: 2.2 (95% CI -8.0 to 12.4)

Population analysed: Full anlysis set

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first dose of investigational product (naproxen or loratidine) or first dose of pegfilgrastim, whichever occurred first, until 30 days after last dose, up to 24 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
No Prophylactic Intervention	34 of 196 (17.3%)	184 of 196 (93.9%)	Not reported
Naproxen 500mg BID	30 of 193 (15.5%)	190 of 193 (98.4%)	Not reported
Loratadine 10mg QD	14 of 198 (7.1%)	193 of 198 (97.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 29147854Kirshner JJ, McDonald MC 3rd, Kruter F, Guinigundo AS, Vanni L, Maxwell CL, Reiner M, Upchurch TE, Garcia J, Morrow PK. NOLAN: a randomized, phase 2 study to estimate the effect of prophylactic naproxen or loratadine vs no prophylactic treatment on bone pain in patients with early-stage breast cancer receiving chemotherapy and pegfilgrastim. Support Care Cancer. 2018 Apr;26(4):1323-1334. doi: 10.1007/s00520-017-3959-2. Epub 2017 Nov 16.
AmgenTrials clinical trials websiteLink provided by the sponsor.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

MD study director

Amgen

83 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Naproxen, Loratadine and Pegfilgrastim in people with Bone Pain in Stage I - III Breast Cancer, run by Amgen at 83 sites 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 0 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 30 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 83 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants With Bone Pain (All Grades) in Cycle 1 (time frame: Cycle 1 (approximately 4 weeks, depending on the chemotherapy dosing interval)). 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 NCT01712009, which also lists 1 linked publication.

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 30 Jan 2018.